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4. Clinical antiviral efficacy of favipiravir in early COVID-19 (PLATCOV): an open-label, randomised, controlled, adaptive platform trial

Author

Luvira, Viravarn, Schilling, William H. K., Jittamala, Podjanee, Watson, James A., Boyd, Simon, Siripoon, Tanaya, Ngamprasertchai, Thundon, Almeida, Pedro J., Ekkapongpisit, Maneerat, Cruz, Cintia, Callery, James J., Singh, Shivani, Tuntipaiboontana, Runch, Kruabkontho, Varaporn, Ngernseng, Thatsanun, Tubprasert, Jaruwan, Abdad, Mohammad Yazid, Keayarsa, Srisuda, Madmanee, Wanassanan, Aguiar, Renato S., Santos, Franciele M., Hanboonkunupakarn, Pongtorn, Hanboonkunupakarn, Borimas, Poovorawan, Kittiyod, Imwong, Mallika, Taylor, Walter R. J., Chotivanich, Vasin, Chotivanich, Kesinee, Pukrittayakamee, Sasithon, Dondorp, Arjen M., Day, Nicholas P. J., Teixeira, Mauro M., Piyaphanee, Watcharapong, Phumratanaprapin, Weerapong, and White, Nicholas J.

Published
2024
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5. Methaemoglobin as a surrogate marker of primaquine antihypnozoite activity in Plasmodium vivax malaria: A systematic review and individual patient data meta-analysis

Author

Fadilah, Ihsan, Commons, Robert J., Chau, Nguyen Hoang, Chu, Cindy S., Day, Nicholas P. J., Koh, Gavin C. K. W., Green, Justin A., Lacerda, Marcus VG, Llanos-Cuentas, Alejandro, Nelwan, Erni J., Nosten, Francois, Pasaribu, Ayodhia Pitaloka, Sutanto, Inge, Taylor, Walter R. J., Thriemer, Kamala, Price, Ric N., White, Nicholas J., Baird, J. Kevin, and Watson, James A.

Subjects
Hemoglobin -- Measurement -- Health aspects, Diseases -- Relapse, Primaquine -- Dosage and administration -- Physiological aspects, Malaria -- Drug therapy, Biological sciences
Abstract

Background The 8-aminoquinolines, primaquine and tafenoquine, are the only available drugs for the radical cure of Plasmodium vivax hypnozoites. Previous evidence suggests that there is dose-dependent 8-aminoquinoline induced methaemoglobinaemia and that higher methaemoglobin concentrations are associated with a lower risk of P. vivax recurrence. We undertook a systematic review and individual patient data meta-analysis to examine the utility of methaemoglobin as a population-level surrogate endpoint for 8-aminoquinoline antihypnozoite activity to prevent P. vivax recurrence. Methods and findings We conducted a systematic search of Medline, Embase, Web of Science, and the Cochrane Library, from 1 January 2000 to 29 September 2022, inclusive, of prospective clinical efficacy studies of acute, uncomplicated P. vivax malaria mono-infections treated with radical curative doses of primaquine. The day 7 methaemoglobin concentration was the primary surrogate outcome of interest. The primary clinical outcome was the time to first P. vivax recurrence between day 7 and day 120 after enrolment. We used multivariable Cox proportional-hazards regression with site random-effects to characterise the time to first recurrence as a function of the day 7 methaemoglobin percentage (log base 2 transformed), adjusted for the partner schizonticidal drug, the primaquine regimen duration as a proxy for the total primaquine dose (mg base/kg), the daily primaquine dose (mg/kg), and other factors. The systematic review protocol was registered with PROSPERO (CRD42023345956). We identified 219 P. vivax efficacy studies, of which 8 provided relevant individual-level data from patients treated with primaquine; all were randomised, parallel arm clinical trials assessed as having low or moderate risk of bias. In the primary analysis data set, there were 1,747 patients with normal glucose-6-phosphate dehydrogenase (G6PD) activity enrolled from 24 study sites across 8 different countries (Indonesia, Brazil, Vietnam, Thailand, Peru, Colombia, Ethiopia, and India). We observed an increasing dose-response relationship between the daily weight-adjusted primaquine dose and day 7 methaemoglobin level. For a given primaquine dose regimen, an observed doubling in day 7 methaemoglobin percentage was associated with an estimated 30% reduction in the risk of P. vivax recurrence (adjusted hazard ratio = 0.70; 95% confidence interval [CI] [0.57, 0.86]; p = 0.0005). These pooled estimates were largely consistent across the study sites. Using day 7 methaemoglobin as a surrogate endpoint for recurrence would reduce required sample sizes by approximately 40%. Study limitations include the inability to distinguish between recrudescence, reinfection, and relapse in P. vivax recurrences. Conclusions For a given primaquine regimen, higher methaemoglobin on day 7 was associated with a reduced risk of P. vivax recurrence. Under our proposed causal model, this justifies the use of methaemoglobin as a population-level surrogate endpoint for primaquine antihypnozoite activity in patients with P. vivax malaria who have normal G6PD activity., Author(s): Ihsan Fadilah 1,2,*, Robert J. Commons 3,4,5, Nguyen Hoang Chau 6, Cindy S. Chu 2,7, Nicholas P. J. Day 2,8, Gavin C. K. W. Koh 9, Justin A. Green [...]

Published
2024
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6. Evaluation of hydroxychloroquine or chloroquine for the prevention of COVID-19 (COPCOV): A double-blind, randomised, placebo-controlled trial

Author

Schilling, William H. K., Mukaka, Mavuto, Callery, James J., Llewelyn, Martin J., Cruz, Cintia V., Dhorda, Mehul, Ngernseng, Thatsanun, Waithira, Naomi, Ekkapongpisit, Maneerat, Watson, James A., Chandna, Arjun, Nelwan, Erni J., Hamers, Raph L., Etyang, Anthony, Beg, Mohammad Asim, Sow, Samba, Yavo, William, Allabi, Aurel Constant, Basnyat, Buddha, Sharma, Sanjib Kumar, Amofa-Sekyi, Modupe, Yonga, Paul, Adler, Amanda, Yuentrakul, Prayoon, Cope, Tanya, Thaipadungpanit, Janjira, Rienpradub, Panuvit, Imwong, Mallika, Abdad, Mohammad Yazid, Blacksell, Stuart D., Tarning, Joel, Goudjo, Frejus Faustin, Dossou, Ange D., Konaté-Touré, Abibatou, Assi, Serge-Brice, Ouffoué, Kra, Nasronudin, Nasronudin, Rachman, Brian Eka, Romadhon, Pradana Zaky, Dewanto, Didi Darmahadi, Heryana, Made Oka, Novi, Theresia, Pasaribu, Ayodhia Pitaloka, Mutiara, Mutiara, Nasution, Miranda Putri Rahayu, Khairunnisa, Khairunnisa, Dalimunthe, Fauzan Azima, Airlangga, Eka, Fahrezzy, Akmal, Subronto, Yanri, Ananda, Nur Rahmi, Rahardjani, Mutia, Rimainar, Atika, Lucinde, Ruth Khadembu, Timbwa, Molline, Onyango, Otieno Edwin, Agutu, Clara, Akech, Samuel, Hamaluba, Mainga, Kipyego, Jairus, Ngachi, Obadiah, Haidara, Fadima Cheick, Traoré, Oumar Y., Diarra, François, Khanal, Basudha, Dahal, Piyush, Shrestha, Suchita, Rijal, Samita, Kabore, Youssouf, Adehossi, Eric, Guindo, Ousmane, Qamar, Farah Naz, Kazi, Abdul Momin, Woodrow, Charles J., Laird, Steven, Cheeba, Maina, Ayles, Helen, Cheah, Phaik Yeong, Taylor, Walter R. J., Batty, Elizabeth M., Chotivanich, Kesinee, Pukrittayakamee, Sasithon, Phumratanaprapin, Weerapong, von Seidlein, Lorenz, Dondorp, Arjen, Day, Nicholas P. J., and White, Nicholas J.

Subjects
Hydroxychloroquine -- Testing, Chloroquine -- Testing, Biological sciences
Abstract

Background Hydroxychloroquine (HCQ) has proved ineffective in treating patients hospitalised with Coronavirus Disease 2019 (COVID-19), but uncertainty remains over its safety and efficacy in chemoprevention. Previous chemoprevention randomised controlled trials (RCTs) did not individually show benefit of HCQ against COVID-19 and, although meta-analysis did suggest clinical benefit, guidelines recommend against its use. Methods and findings Healthy adult participants from the healthcare setting, and later from the community, were enrolled in 26 centres in 11 countries to a double-blind, placebo-controlled, randomised trial of COVID-19 chemoprevention. HCQ was evaluated in Europe and Africa, and chloroquine (CQ) was evaluated in Asia, (both base equivalent of 155 mg once daily). The primary endpoint was symptomatic COVID-19, confirmed by PCR or seroconversion during the 3-month follow-up period. The secondary and tertiary endpoints were: asymptomatic laboratory-confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection; severity of COVID-19 symptoms; all-cause PCR-confirmed symptomatic acute respiratory illness (including SARS-CoV-2 infection); participant reported number of workdays lost; genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity (not reported here); and health economic analyses of HCQ and CQ prophylaxis on costs and quality of life measures (not reported here). The primary and safety analyses were conducted in the intention-to-treat (ITT) population. Recruitment of 40,000 (20,000 HCQ arm, 20,000 CQ arm) participants was planned but was not possible because of protracted delays resulting from controversies over efficacy and adverse events with HCQ use, vaccine rollout in some countries, and other factors. Between 29 April 2020 and 10 March 2022, 4,652 participants (46% females) were enrolled (HCQ/CQ n = 2,320; placebo n = 2,332). The median (IQR) age was 29 (23 to 39) years. SARS-CoV-2 infections (symptomatic and asymptomatic) occurred in 1,071 (23%) participants. For the primary endpoint the incidence of symptomatic COVID-19 was 240/2,320 in the HCQ/CQ versus 284/2,332 in the placebo arms (risk ratio (RR) 0.85 [95% confidence interval, 0.72 to 1.00; p = 0.05]). For the secondary and tertiary outcomes asymptomatic SARS-CoV-2 infections occurred in 11.5% of HCQ/CQ recipients and 12.0% of placebo recipients: RR: 0.96 (95% CI, 0.82 to 1.12; p = 0.6). There were no differences in the severity of symptoms between the groups and no severe illnesses. HCQ/CQ chemoprevention was associated with fewer PCR-confirmed all-cause respiratory infections (predominantly SARS-CoV-2): RR 0.61 (95% CI, 0.42 to 0.88; p = 0.009) and fewer days lost to work because of illness: 104 days per 1,000 participants over 90 days (95% CI, 12 to 199 days; p < 0.001). The prespecified meta-analysis of all published pre-exposure RCTs indicates that HCQ/CQ prophylaxis provided a moderate protective benefit against symptomatic COVID-19: RR 0.80 (95% CI, 0.71 to 0.91). Both drugs were well tolerated with no drug-related serious adverse events (SAEs). Study limitations include the smaller than planned study size, the relatively low number of PCR-confirmed infections, and the lower comparative accuracy of serology endpoints (in particular, the adapted dried blood spot method) compared to the PCR endpoint. The COPCOV trial was registered with ClinicalTrials.gov; number NCT04303507. Interpretation In this large placebo-controlled, double-blind randomised trial, HCQ and CQ were safe and well tolerated in COVID-19 chemoprevention, and there was evidence of moderate protective benefit in a meta-analysis including this trial and similar RCTs. Trial registration ClinicalTrials.gov NCT04303507; ISRCTN Registry ISRCTN10207947., Author(s): William H. K. Schilling 1,2,*, Mavuto Mukaka 1,2, James J. Callery 1,2, Martin J. Llewelyn 3,4, Cintia V. Cruz 1,2, Mehul Dhorda 1,2, Thatsanun Ngernseng 1, Naomi Waithira 1,2, [...]

Published
2024
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7. Primaquine for uncomplicated Plasmodium vivax malaria in children younger than 15 years: a systematic review and individual patient data meta-analysis

Author

Adhikari, Bipin, Alam, Mohammad Shafiul, Anstey, Nicholas M, Assefa, Ashenafi, Baird, J Kevin, Boyd, Sarah C, Chau, Nguyen H, Day, Nicholas PJ, Degaga, Tamiru Shibiru, Dondorp, Arjen M, Erhart, Annette, Ferreira, Marcelo U, Ghimire, Prakash, Khan, Wasif A, Ley, Benedikt, Mekuria, Asrat H, Mueller, Ivo, Naadim, Mohammad N, Nosten, Francois, Price, David J, Pukrittayakamee, Sasithon, Rowland, Mark, Sattabongkot, Jetsumon, SuarezKurtz, Guilherme, Sutanto, Inge, von Seidlein, Lorenz, William, Timothy, Woodrow, Charles J, Woyessa, Adugna, Commons, Robert J, Rajasekhar, Megha, Allen, Elizabeth N, Yilma, Daniel, Chotsiri, Palang, Abreha, Tesfay, Adam, Ishag, Awab, Ghulam Rahim, Barber, Bridget E, Brasil, Larissa W, Chu, Cindy S, Cui, Liwang, Edler, Peta, Gomes, Margarete do Socorro M, Gonzalez‑Ceron, Lilia, Grigg, Matthew J, Hamid, Muzamil Mahdi Abdel, Hwang, Jimee, Karunajeewa, Harin, Lacerda, Marcus V G, Ladeia-Andrade, Simone, Leslie, Toby, Longley, Rhea J, Monteiro, Wuelton Marcelo, Pasaribu, Ayodhia Pitaloka, Poespoprodjo, Jeanne Rini, Richmond, Caitlin L, Rijal, Komal Raj, Taylor, Walter R J, Thanh, Pham Vinh, Thriemer, Kamala, Vieira, José Luiz F, White, Nicholas J, Zuluaga-Idarraga, Lina M, Workman, Lesley J, Tarning, Joel, Stepniewska, Kasia, Guerin, Philippe J, Simpson, Julie A, Barnes, Karen I, and Price, Ric N

Published
2024
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8. Factors affecting haemoglobin dynamics in African children with acute uncomplicated Plasmodium falciparum malaria treated with single low-dose primaquine or placebo

Author

Onyamboko, Marie A., Olupot-Olupot, Peter, Were, Winifred, Namayanja, Cate, Onyas, Peter, Titin, Harriet, Baseke, Joy, Muhindo, Rita, Kayembe, Daddy K., Ndjowo, Pauline O., Basara, Benjamin B., Okalebo, Charles B., Williams, Thomas N., Uyoga, Sophie, Taya, Chiraporn, Bamisaiye, Adeola, Fanello, Caterina, Maitland, Kathryn, Day, Nicholas P. J., Taylor, Walter R. J., and Mukaka, Mavuto

Published
2023
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9. Effect of adherence to primaquine on the risk of Plasmodium vivax recurrence: a WorldWide Antimalarial Resistance Network systematic review and individual patient data meta-analysis

Author

Mehdipour, Parinaz, Rajasekhar, Megha, Dini, Saber, Zaloumis, Sophie, Abreha, Tesfay, Adam, Ishag, Awab, Ghulam Rahim, Baird, J. Kevin, Brasil, Larissa W., Chu, Cindy S., Cui, Liwang, Daher, André, do Socorro M Gomes, Margarete, Gonzalez‑Ceron, Lilia, Hwang, Jimee, Karunajeewa, Harin, Lacerda, Marcus V. G., Ladeia-Andrade, Simone, Leslie, Toby, Ley, Benedikt, Lidia, Kartini, Llanos-Cuentas, Alejandro, Longley, Rhea J., Monteiro, Wuelton Marcelo, Pereira, Dhelio B., Rijal, Komal Raj, Saravu, Kavitha, Sutanto, Inge, Taylor, Walter R. J., Thanh, Pham Vinh, Thriemer, Kamala, Vieira, José Luiz F., White, Nicholas J., Zuluaga-Idarraga, Lina M., Guerin, Philippe J., Price, Ric N., Simpson, Julie A., and Commons, Robert J.

Published
2023
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10. The heterogeneity of symptom reporting across study sites: a secondary analysis of a randomised placebo-controlled multicentre antimalarial trial

Author

Thriemer, Kamala, Commons, Robert James, Rajasekhar, Megha, Degaga, Tamiru Shibiru, Chand, Krisin, Chau, Nguyen Hoang, Assefa, Ashenafi, Naddim, Mohammad Nader, Pasaribu, Ayodhia Pitaloka, Rahim, Awab Ghulam, Sutanto, Inge, Hien, Tran Tinh, Hailu, Asrat, Hasanzai, Mohammad Anwar, Ekawati, Lenny L., Woyessa, Adugna, Teferi, Tedla, Waithira, Naomi, Taylor, Walter R. J., Ley, Benedikt, Dondorp, Arjen, Baird, J. Kevin, White, Nicholas J., Day, Nicholas P., Price, Ric N., Simpson, Julie A., and von Seidlein, Lorenz

Published
2023
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11. Effect of primaquine dose on the risk of recurrence in patients with uncomplicated Plasmodium vivax: a systematic review and individual patient data meta-analysis

Author

Adhikari, Bipin, Anstey, Nicholas M, Assefa, Ashenafi, Boyd, Sarah C, Chau, Nguyen Hoang, Day, Nicholas PJ, Degaga, Tamiru Shibiru, Dondorp, Arjen M, Erhart, Annette, Ferreira, Marcelo Urbano, Ghimire, Prakash, Green, Justin A, Koh, Gavin CKW, Mekuria, Asrat Hailu, Mueller, Ivo, Naadim, Mohammad Nader, Nelwan, Erni J, Nosten, Francois, Price, David J, Sattabongkot, Jetsumon, Stepniewska, Kasia, von Seidlein, Lorenz, William, Timothy, Woodrow, Charles J, Woyessa, Adugna, Commons, Robert J, Rajasekhar, Megha, Edler, Peta, Abreha, Tesfay, Awab, Ghulam R, Baird, J Kevin, Barber, Bridget E, Chu, Cindy S, Cui, Liwang, Daher, André, Gonzalez-Ceron, Lilia, Grigg, Matthew J, Hwang, Jimee, Karunajeewa, Harin, Lacerda, Marcus V G, Ladeia-Andrade, Simone, Lidia, Kartini, Llanos-Cuentas, Alejandro, Longley, Rhea J, Pereira, Dhelio B, Pasaribu, Ayodhia P, Pukrittayakamee, Sasithon, Rijal, Komal R, Sutanto, Inge, Taylor, Walter R J, Thanh, Pham V, Thriemer, Kamala, Vieira, José Luiz F, Watson, James A, Zuluaga-Idarraga, Lina M, White, Nicholas J, Guerin, Philippe J, Simpson, Julie A, and Price, Ric N

Published
2024
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12. Primaquine dose and the risk of haemolysis in patients with uncomplicated Plasmodium vivax malaria: a systematic review and individual patient data meta-analysis

Author

Adhikari, Bipin, Alam, Mohammad Shafiul, Anstey, Nicholas M, Assefa, Ashenafi, Boyd, Sarah C, Chau, Nguyen Hoang, Day, Nicholas PJ, Degaga, Tamiru Shibiru, Dondorp, Arjen M, Ferreira, Marcelo Urbano, Ghimire, Prakash, Green, Justin A, Khan, Wasif Ali, Koh, Gavin CKW, Mekuria, Asrat Hailu, Naadim, Mohammad Nader, Nelwan, Erni J, Nosten, Francois, Pasaribu, Ayodhia Pitaloka, Price, David J, Stepniewska, Kasia, von Seidlein, Lorenz, William, Timothy, Woodrow, Charles J, Woyessa, Adugna, Rajasekhar, Megha, Simpson, Julie A, Ley, Benedikt, Edler, Peta, Chu, Cindy S, Abreha, Tesfay, Awab, Ghulam R, Baird, J Kevin, Bancone, Germana, Barber, Bridget E, Grigg, Matthew J, Hwang, Jimee, Karunajeewa, Harin, Lacerda, Marcus V G, Ladeia-Andrade, Simone, Llanos-Cuentas, Alejandro, Pukrittayakamee, Sasithon, Rijal, Komal R, Saravu, Kavitha, Sutanto, Inge, Taylor, Walter R J, Thriemer, Kamala, Watson, James A, Guerin, Philippe J, White, Nicholas J, Price, Ric N, and Commons, Robert J

Published
2024
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13. Antiviral efficacy of molnupiravir versus ritonavir-boosted nirmatrelvir in patients with early symptomatic COVID-19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial

Author

White, Nicholas J, Schilling, William HK, Phumratanaprapin, Weerapong, Luvira, Viravarn, Callery, James J, Day, Nicholas PJ, Pukrittayakamee, Sasithon, Boyd, Simon, Cruz, Cintia, Dondorp, Arjen M, Taylor, Walter RJ, Watson, James A, Piyaphanee, Watcharapong, Poovorawan, Kittiyod, Ngamprasertchai, Thundon, Siripoon, Tanaya, Hanboonkunupakarn, Borimas, Chotivanich, Kesinee, Jittamala, Podjanee, Imwong, Mallika, Thaipadungpanit, Janjira, Ekkapongpisit, Maneerat, Kruabkontho, Varaporn, Ngernseng, Thatsanun, Tubprasert, Jaruwan, Abdad, Mohammad Yazid, Batty, Elizabeth M, Singh, Shivani, Chotivanich, Vasin, Ruksakul, Wiroj, Sangketchon, Chunlanee, Hanboonkunupakarn, Pongtorn, Sookprome, Sakol, Teixeira, Mauro, Almeida, Pedro J, Aguiar, Renato S, Santos, Franciele, Ashley, Elizabeth, Vongsouvath, Manivanh, Phommasone, Koukeo, Dubot-Pérès, Audrey, Vidhamaly, Sisouphanh, Chingsanoon, Ammala, Bisayher, Sixiong, Chommanam, Danoy, Evans, Terry John, Vidhamaly, Vayouly, Boutthasavong, Latsaniphone, Mayxay, Mayfong, Potaporn, Manus, Srisubat, Attasit, Loharjun, Bootsakorn, Schilling, William H K, Saroj, Manisaree, Tanglakmankhong, Nuttakan, Madmanee, Wanassanan, Kouhathong, Jindarat, Suwannasin, Kanokon, Pagornrat, Watcharee, Piaraksa, Nattaporn, Taylor, Walter R J, Day, Nicholas P J, and Teixeira, Mauro M

Published
2024
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16. Arterolane–piperaquine–mefloquine versus arterolane–piperaquine and artemether–lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a single-centre, open-label, randomised, non-inferiority trial

Author

Hamaluba, Mainga, van der Pluijm, Rob W, Weya, Joseph, Njuguna, Patricia, Ngama, Mwanajuma, Kalume, Peter, Mwambingu, Gabriel, Ngetsa, Caroline, Wambua, Juliana, Boga, Mwanamvua, Mturi, Neema, Lal, Altaf A, Khuroo, Arshad, Taylor, Walter R J, Gonçalves, Sónia, Miotto, Olivo, Dhorda, Mehul, Mutinda, Brian, Mukaka, Mavuto, Waithira, Naomi, Hoglund, Richard M, Imwong, Mallika, Tarning, Joel, Day, Nicholas P J, White, Nicholas J, Bejon, Philip, and Dondorp, Arjen M

Published
2021
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17. Primaquine for uncomplicated Plasmodium vivaxmalaria in children younger than 15 years: a systematic review and individual patient data meta-analysis

Author

Commons, Robert J, Rajasekhar, Megha, Allen, Elizabeth N, Yilma, Daniel, Chotsiri, Palang, Abreha, Tesfay, Adam, Ishag, Awab, Ghulam Rahim, Barber, Bridget E, Brasil, Larissa W, Chu, Cindy S, Cui, Liwang, Edler, Peta, Gomes, Margarete do Socorro M, Gonzalez‑Ceron, Lilia, Grigg, Matthew J, Hamid, Muzamil Mahdi Abdel, Hwang, Jimee, Karunajeewa, Harin, Lacerda, Marcus V G, Ladeia-Andrade, Simone, Leslie, Toby, Longley, Rhea J, Monteiro, Wuelton Marcelo, Pasaribu, Ayodhia Pitaloka, Poespoprodjo, Jeanne Rini, Richmond, Caitlin L, Rijal, Komal Raj, Taylor, Walter R J, Thanh, Pham Vinh, Thriemer, Kamala, Vieira, José Luiz F, White, Nicholas J, Zuluaga-Idarraga, Lina M, Workman, Lesley J, Tarning, Joel, Stepniewska, Kasia, Guerin, Philippe J, Simpson, Julie A, Barnes, Karen I, Price, Ric N, Adhikari, Bipin, Alam, Mohammad Shafiul, Anstey, Nicholas M, Assefa, Ashenafi, Baird, J Kevin, Boyd, Sarah C, Chau, Nguyen H, Day, Nicholas PJ, Degaga, Tamiru Shibiru, Dondorp, Arjen M, Erhart, Annette, Ferreira, Marcelo U, Ghimire, Prakash, Khan, Wasif A, Ley, Benedikt, Mekuria, Asrat H, Mueller, Ivo, Naadim, Mohammad N, Nosten, Francois, Price, David J, Pukrittayakamee, Sasithon, Rowland, Mark, Sattabongkot, Jetsumon, SuarezKurtz, Guilherme, Sutanto, Inge, von Seidlein, Lorenz, William, Timothy, Woodrow, Charles J, and Woyessa, Adugna

Abstract

Primaquine, the only widely available treatment to prevent relapsing Plasmodium vivaxmalaria, is produced as 15 mg tablets, and new paediatric formulations are being developed. To inform the optimal primaquine dosing regimen for children, we aimed to determine the efficacy and safety of different primaquine dose strategies in children younger than 15 years.

Published
2024
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19. Case Series of Primaquine-Induced Haemolytic Events in Controlled Trials with G6PD Screening

Author

Kosasih, Ayleen, primary, James, Robert, additional, Chau, Nguyen Hoang, additional, Karman, Michelle M., additional, Panggalo, Lydia Visita, additional, Wini, Lyndes, additional, Thanh, Ngo Viet, additional, Obadia, Thomas, additional, Satyagraha, Ari Winasti, additional, Asih, Puji Budi Setia, additional, Syafruddin, Din, additional, Taylor, Walter R. J., additional, Mueller, Ivo, additional, Sutanto, Inge, additional, Karunajeewa, Harin, additional, Pasaribu, Ayodhia Pitaloka, additional, and Baird, J. Kevin, additional

Published
2023
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20. Prevalence of soil-transmitted helminths and associated risk factors among primary school children in Kandahar, Afghanistan: A cross-sectional analytical study

Author

Rahimi, Bilal Ahmad, primary, Rafiqi, Najeebullah, additional, Tareen, Zarghoon, additional, Kakar, Khalil Ahmad, additional, Wafa, Mohammad Hashim, additional, Stanikzai, Muhammad Haroon, additional, Beg, Mohammad Asim, additional, Dost, Abdul Khaliq, additional, and Taylor, Walter R., additional

Published
2023
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21. Weekly primaquine for radical cure of patients with Plasmodium vivax malaria and glucose-6-phosphate dehydrogenase deficiency

Author

Taylor, Walter R. J., primary, Meagher, Niamh, additional, Ley, Benedikt, additional, Thriemer, Kamala, additional, Bancone, Germana, additional, Satyagraha, Ari, additional, Assefa, Ashenafi, additional, Chand, Krisin, additional, Chau, Nguyen Hoang, additional, Dhorda, Mehul, additional, Degaga, Tamiru S., additional, Ekawati, Lenny L., additional, Hailu, Asrat, additional, Hasanzai, Mohammad Anwar, additional, Naddim, Mohammad Nader, additional, Pasaribu, Ayodhia Pitaloka, additional, Rahim, Awab Ghulam, additional, Sutanto, Inge, additional, Thanh, Ngo Viet, additional, Tuyet-Trinh, Nguyen Thi, additional, Waithira, Naomi, additional, Woyessa, Adugna, additional, Dondorp, Arjen, additional, von Seidlein, Lorenz, additional, Simpson, Julie A., additional, White, Nicholas J., additional, Baird, J. Kevin, additional, Day, Nicholas P., additional, and Price, Ric N., additional

Published
2023
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22. Antiviral efficacy of molnupiravir versus ritonavir-boosted nirmatrelvir in patients with early symptomatic COVID-19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial

Author

Schilling, William H K, primary, Jittamala, Podjanee, additional, Watson, James A, additional, Boyd, Simon, additional, Luvira, Viravarn, additional, Siripoon, Tanaya, additional, Ngamprasertchai, Thundon, additional, Batty, Elizabeth M, additional, Cruz, Cintia, additional, Callery, James J, additional, Singh, Shivani, additional, Saroj, Manisaree, additional, Kruabkontho, Varaporn, additional, Ngernseng, Thatsanun, additional, Tanglakmankhong, Nuttakan, additional, Tubprasert, Jaruwan, additional, Abdad, Mohammad Yazid, additional, Madmanee, Wanassanan, additional, Kouhathong, Jindarat, additional, Suwannasin, Kanokon, additional, Pagornrat, Watcharee, additional, Piaraksa, Nattaporn, additional, Hanboonkunupakarn, Pongtorn, additional, Hanboonkunupakarn, Borimas, additional, Poovorawan, Kittiyod, additional, Potaporn, Manus, additional, Srisubat, Attasit, additional, Loharjun, Bootsakorn, additional, Taylor, Walter R J, additional, Chotivanich, Vasin, additional, Chotivanich, Kesinee, additional, Imwong, Mallika, additional, Pukrittayakamee, Sasithon, additional, Dondorp, Arjen M, additional, Day, Nicholas P J, additional, Teixeira, Mauro M, additional, Piyaphanee, Watcharapong, additional, Phumratanaprapin, Weerapong, additional, White, Nicholas J, additional, Schilling, William HK, additional, Day, Nicholas PJ, additional, Taylor, Walter RJ, additional, Thaipadungpanit, Janjira, additional, Ekkapongpisit, Maneerat, additional, Ruksakul, Wiroj, additional, Sangketchon, Chunlanee, additional, Sookprome, Sakol, additional, Teixeira, Mauro, additional, Almeida, Pedro J, additional, Aguiar, Renato S, additional, Santos, Franciele, additional, Ashley, Elizabeth, additional, Vongsouvath, Manivanh, additional, Phommasone, Koukeo, additional, Dubot-Pérès, Audrey, additional, Vidhamaly, Sisouphanh, additional, Chingsanoon, Ammala, additional, Bisayher, Sixiong, additional, Chommanam, Danoy, additional, Evans, Terry John, additional, Vidhamaly, Vayouly, additional, Boutthasavong, Latsaniphone, additional, and Mayxay, Mayfong, additional

Published
2023
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24. The effect of chloroquine dose and primaquine on Plasmodium vivax recurrence: a WorldWide Antimalarial Resistance Network systematic review and individual patient pooled meta-analysis

Author

Commons, Robert J, Simpson, Julie A, Thriemer, Kamala, Humphreys, Georgina S, Abreha, Tesfay, Alemu, Sisay G, Añez, Arletta, Anstey, Nicholas M, Awab, Ghulam R, Baird, J Kevin, Barber, Bridget E, Borghini-Fuhrer, Isabelle, Chu, Cindy S, D'Alessandro, Umberto, Dahal, Prabin, Daher, André, de Vries, Peter J, Erhart, Annette, Gomes, Margarete S M, Gonzalez-Ceron, Lilia, Grigg, Matthew J, Heidari, Aliehsan, Hwang, Jimee, Kager, Piet A, Ketema, Tsige, Khan, Wasif A, Lacerda, Marcus V G, Leslie, Toby, Ley, Benedikt, Lidia, Kartini, Monteiro, Wuelton M, Nosten, Francois, Pereira, Dhelio B, Phan, Giao T, Phyo, Aung P, Rowland, Mark, Saravu, Kavitha, Sibley, Carol H, Siqueira, André M, Stepniewska, Kasia, Sutanto, Inge, Taylor, Walter R J, Thwaites, Guy, Tran, Binh Q, Tran, Hien T, Valecha, Neena, Vieira, José Luiz F, Wangchuk, Sonam, William, Timothy, Woodrow, Charles J, Zuluaga-Idarraga, Lina, Guerin, Philippe J, White, Nicholas J, and Price, Ric N

Published
2018
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25. Clinical antiviral efficacy of remdesivir in COVID-19: an open label, randomized, controlled adaptive platform trial (PLATCOV)

Author

Jittamala, Podjanee, primary, Schilling, William H K, additional, Watson, James A, additional, Luvira, Viravarn, additional, Siripoon, Tanaya, additional, Ngamprasertchai, Thundon, additional, Almeida, Pedro J, additional, Ekkapongpisit, Maneerat, additional, Cruz, Cintia, additional, Callery, James J, additional, Boyd, Simon, additional, Anunsittichai, Orawan, additional, Hongsuwan, Maliwan, additional, Singhaboot, Yutatirat, additional, Pagornrat, Watcharee, additional, Tuntipaiboontana, Runch, additional, Kruabkontho, Varaporn, additional, Ngernseng, Thatsanun, additional, Tubprasert, Jaruwan, additional, Abdad, Mohammad Yazid, additional, Keayarsa, Srisuda, additional, Madmanee, Wanassanan, additional, Aguiar, Renato S, additional, Santos, Franciele M, additional, Batty, Elizabeth M, additional, Hanboonkunupakarn, Pongtorn, additional, Hanboonkunupakarn, Borimas, additional, Sookprome, Sakol, additional, Poovorawan, Kittiyod, additional, Imwong, Mallika, additional, Taylor, Walter R J, additional, Chotivanich, Vasin, additional, Sangketchon, Chunlanee, additional, Ruksakul, Wiroj, additional, Chotivanich, Kesinee, additional, Pukrittayakamee, Sasithon, additional, Dondorp, Arjen M, additional, Day, Nicholas P J, additional, Teixeira, Mauro M, additional, Piyaphanee, Watcharapong, additional, Phumratanaprapin, Weerapong, additional, and White, Nicholas J, additional

Published
2023
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31. Safety of age-dosed, single low-dose primaquine in children with glucose-6-phosphate dehydrogenase deficiency who are infected with Plasmodium falciparum in Uganda and the Democratic Republic of the Congo: a randomised, double-blind, placebo-controlled, non-inferiority trial

Author

Taylor, Walter R, primary, Olupot-Olupot, Peter, additional, Onyamboko, Marie A, additional, Peerawaranun, Pimnara, additional, Weere, Winifred, additional, Namayanja, Cate, additional, Onyas, Peter, additional, Titin, Harriet, additional, Baseke, Joy, additional, Muhindo, Rita, additional, Kayembe, Daddy K, additional, Ndjowo, Pauline O, additional, Basara, Benjamin B, additional, Bongo, Georgette S, additional, Okalebo, Charles B, additional, Abongo, Grace, additional, Uyoga, Sophie, additional, Williams, Thomas N, additional, Taya, Chiraporn, additional, Dhorda, Mehul, additional, Tarning, Joel, additional, Dondorp, Arjen M, additional, Waithira, Naomi, additional, Fanello, Caterina, additional, Maitland, Kathryn, additional, Mukaka, Mavuto, additional, and Day, Nicholas J P, additional

Published
2023
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32. Variability in white blood cell count during uncomplicated malaria and implications for parasite density estimation : a WorldWide Antimalarial Resistance Network individual patient data meta-analysis

Author

Wynberg, Elke, Commons, Robert J., Humphreys, Georgina, Ashurst, Hazel, Burrow, Rebekah, Adjei, George O., Adjuik, Martin, Anstey, Nicholas M., Anvikar, Anup, Baird, Kevin J., Barber, Bridget E., Barennes, Hubert, Baudin, Elisabeth, Bell, David J., Bethell, Delia, Binh, Tran Quang, Borghini, Isabelle, Chu, Cindy S., Daher, Andre, D'Alessandro, Umberto, Das, Debashish, Davis, Timothy Me, de Vries, Peter J., Djimde, Abdoulaye A., Dondorp, Arjen M., Dorsey, Grant, Faucher, Jean-Francois F., Fogg, Carole, Gaye, Oumar, Grigg, Matthew, Hatz, Christoph, Kager, Piet A., Lacerda, Marcus, Laman, Moses, Mårtensson, Andreas, Menan, Herve Ignace Eby, Monteiro, Wuelton M., Moore, Brioni R., Nosten, Francois, Ogutu, Bernhards, Osorio, Lyda, Penali, Louis K., Pereira, Dhelio B., Rahim, Awab G., Ramharter, Michael, Sagara, Issaka, Schramm, Birgit, Seidlein, Lorenz, Siqueira, Andre M., Sirima, Sodiomon B., Starzengruber, Peter, Sutanto, Inge, Taylor, Walter R., Toure, Offianan A., Utzinger, Jurg, Valea, Innocent, Valentini, Giovanni, White, Nicholas J., William, Timothy, Woodrow, Charles J., Richmond, Caitlin L., Guerin, Philippe J., Price, Ric N., Stepniewska, Kasia, Wynberg, Elke, Commons, Robert J., Humphreys, Georgina, Ashurst, Hazel, Burrow, Rebekah, Adjei, George O., Adjuik, Martin, Anstey, Nicholas M., Anvikar, Anup, Baird, Kevin J., Barber, Bridget E., Barennes, Hubert, Baudin, Elisabeth, Bell, David J., Bethell, Delia, Binh, Tran Quang, Borghini, Isabelle, Chu, Cindy S., Daher, Andre, D'Alessandro, Umberto, Das, Debashish, Davis, Timothy Me, de Vries, Peter J., Djimde, Abdoulaye A., Dondorp, Arjen M., Dorsey, Grant, Faucher, Jean-Francois F., Fogg, Carole, Gaye, Oumar, Grigg, Matthew, Hatz, Christoph, Kager, Piet A., Lacerda, Marcus, Laman, Moses, Mårtensson, Andreas, Menan, Herve Ignace Eby, Monteiro, Wuelton M., Moore, Brioni R., Nosten, Francois, Ogutu, Bernhards, Osorio, Lyda, Penali, Louis K., Pereira, Dhelio B., Rahim, Awab G., Ramharter, Michael, Sagara, Issaka, Schramm, Birgit, Seidlein, Lorenz, Siqueira, Andre M., Sirima, Sodiomon B., Starzengruber, Peter, Sutanto, Inge, Taylor, Walter R., Toure, Offianan A., Utzinger, Jurg, Valea, Innocent, Valentini, Giovanni, White, Nicholas J., William, Timothy, Woodrow, Charles J., Richmond, Caitlin L., Guerin, Philippe J., Price, Ric N., and Stepniewska, Kasia

Abstract

Background: The World Health Organization (WHO) recommends that when peripheral malarial parasitaemia is quantified by thick film microscopy, an actual white blood cell (WBC) count from a concurrently collected blood sample is used in calculations. However, in resource-limited settings an assumed WBC count is often used instead. The aim of this study was to describe the variability in WBC count during acute uncomplicated malaria, and estimate the impact of using an assumed value of WBC on estimates of parasite density and clearance. Methods: Uncomplicated malaria drug efficacy studies that measured WBC count were selected from the WorldWide Antimalarial Resistance Network data repository for an individual patient data meta-analysis of WBC counts. Regression models with random intercepts for study-site were used to assess WBC count variability at presentation and during follow-up. Inflation factors for parasitaemia density, and clearance estimates were calculated for methods using assumed WBC counts (8000 cells/mu L and age-stratified values) using estimates derived from the measured WBC value as reference. Results: Eighty-four studies enrolling 27,656 patients with clinically uncomplicated malaria were included. Geometric mean WBC counts (x 1000 cells/mu L) in age groups < 1, 1-4, 5-14 and >= 15 years were 10.5, 8.3, 7.1, 5.7 and 7.5, 7.0, 6.5, 6.0 for individuals with falciparum (n = 24,978) and vivax (n = 2678) malaria, respectively. At presentation, higher WBC counts were seen among patients with higher parasitaemia, severe anaemia and, for individuals with vivax malaria, in regions with shorter regional relapse periodicity. Among falciparum malaria patients, using an assumed WBC count of 8000 cells/mu L resulted in parasite density underestimation by a median (IQR) of 26% (4-41%) in infants < 1 year old but an overestimation by 50% (16-91%) in adults aged = 15 years. Use of age-stratified assumed WBC values removed systematic bias but did not improve pr

Published
2023
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33. The haematological consequences of Plasmodium vivax malaria after chloroquine treatment with and without primaquine: a WorldWide Antimalarial Resistance Network systematic review and individual patient data meta-analysis

Author

Commons, Robert J., Simpson, Julie A., Thriemer, Kamala, Chu, Cindy S., Douglas, Nicholas M., Abreha, Tesfay, Alemu, Sisay G., Añez, Arletta, Anstey, Nicholas M., Aseffa, Abraham, Assefa, Ashenafi, Awab, Ghulam R., Baird, J. Kevin, Barber, Bridget E., Borghini-Fuhrer, Isabelle, D’Alessandro, Umberto, Dahal, Prabin, Daher, André, de Vries, Peter J., Erhart, Annette, Gomes, Margarete S. M., Grigg, Matthew J., Hwang, Jimee, Kager, Piet A., Ketema, Tsige, Khan, Wasif A., Lacerda, Marcus V. G., Leslie, Toby, Ley, Benedikt, Lidia, Kartini, Monteiro, Wuelton M., Pereira, Dhelio B., Phan, Giao T., Phyo, Aung P., Rowland, Mark, Saravu, Kavitha, Sibley, Carol H., Siqueira, André M., Stepniewska, Kasia, Taylor, Walter R. J., Thwaites, Guy, Tran, Binh Q., Hien, Tran T., Vieira, José Luiz F., Wangchuk, Sonam, Watson, James, William, Timothy, Woodrow, Charles J., Nosten, Francois, Guerin, Philippe J., White, Nicholas J., and Price, Ric N.

Published
2019
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36. Haematological consequences of acute uncomplicated falciparum malaria: a WorldWide Antimalarial Resistance Network pooled analysis of individual patient data

Author

Mansoor, Rashid, Commons, Robert J, Douglas, Nicholas M, Abuaku, Benjamin, Achan, Jane, Adam, Ishag, Adjei, George O, Adjuik, Martin, Alemayehu, Bereket H, Allan, Richard, Allen, Elizabeth N, Anvikar, Anupkumar R, Arinaitwe, Emmanuel, Ashley, Elizabeth A, Ashurst, Hazel, Asih, Puji BS, Bakyaita, Nathan, Barennes, Hubert, Barnes, Karen I, Basco, Leonardo, Bassat, Quique, Baudin, Elisabeth, Bell, David J, Bethell, Delia, Bjorkman, Anders, Boulton, Caroline, Bousema, Teun, Brasseur, Philippe, Bukirwa, Hasifa, Burrow, Rebekah, Carrara, Verena I, Cot, Michel, D'Alessandro, Umberto, Das, Debashish, Das, Sabyasachi, Davis, Timothy ME, Desai, Meghna, Djimde, Abdoulaye A, Dondorp, Arjen M, Dorsey, Grant, Drakeley, Chris J, Duparc, Stephan, Espie, Emmanuelle, Etard, Jean-Francois, Falade, Catherine, Faucher, Jean Francois, Filler, Scott, Fogg, Carole, Fukuda, Mark, Gaye, Oumar, Genton, Blaise, Rahim, Awab Ghulam, Gilayeneh, Julius, Gonzalez, Raquel, Grais, Rebecca F, Grandesso, Francesco, Greenwood, Brian, Grivoyannis, Anastasia, Hatz, Christoph, Hodel, Eva Maria, Humphreys, Georgina S, Hwang, Jimee, Ishengoma, Deus, Juma, Elizabeth, Kachur, S Patrick, Kager, Piet A, Kamugisha, Erasmus, Kamya, Moses R, Karema, Corine, Kayentao, Kassoum, Kazienga, Adama, Kiechel, Jean-Rene, Kofoed, Poul-Erik, Koram, Kwadwo, Kremsner, Peter G, Lalloo, David G, Laman, Moses, Lee, Sue J, Lell, Bertrand, Maiga, Amelia W, Martensson, Andreas, Mayxay, Mayfong, Mbacham, Wilfred, McGready, Rose, Menan, Herve, Menard, Didier, Mockenhaupt, Frank, Moore, Brioni R, Muller, Olaf, Nahum, Alain, Ndiaye, Jean-Louis, Newton, Paul N, Ngasala, Billy E, Nikiema, Frederic, Nji, Akindeh M, Noedl, Harald, Nosten, Francois, Ogutu, Bernhards R, Ojurongbe, Olusola, Osorio, Lyda, Ouedraogo, Jean-Bosco, Owusu-Agyei, Seth, Pareek, Anil, Penali, Louis K, Piola, Patrice, Plucinski, Mateusz, Premji, Zul, Ramharter, Michael, Richmond, Caitlin L, Rombo, Lars, Rosenthal, Philip J, Salman, Sam, Same-Ekobo, Albert, Sibley, Carol, Sirima, Sodiomon B, Smithuis, Frank M, Some, Fabrice A, Staedke, Sarah G, Starzengruber, Peter, Strub-Wourgaft, Nathalie, Sutanto, Inge, Swarthout, Todd D, Syafruddin, Din, Talisuna, Ambrose O, Taylor, Walter R, Temu, Emmanuel A, Thwing, Julie I, Tinto, Halidou, Tjitra, Emiliana, Toure, Offianan A, Tran, T Hien, Ursing, Johan, Valea, Innocent, Valentini, Giovanni, van Vugt, Michele, von Seidlein, Lorenz, Ward, Stephen A, Were, Vincent, White, Nicholas J, Woodrow, Charles J, Yavo, William, Yeka, Adoke, Zongo, Issaka, Simpson, Julie A, Guerin, Philippe J, Stepniewska, Kasia, Price, Ric N, Roper, Cally, Resistance, WorldWide Antimalarial, WorldWide Antimalarial Resistance Network Falciparum Haematology Study Group, Vecteurs - Infections tropicales et méditerranéennes (VITROME), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut de Recherche Biomédicale des Armées [Brétigny-sur-Orge] (IRBA), Epidémiologie des Maladies Chroniques en zone tropicale (EpiMaCT), CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM)-OmégaHealth (ΩHealth), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Group, WorldWide Antimalarial Resistance Network Falciparum Haematology Study, Mansoor, R, Ashley, EA, Ashurst, H, Burrow, R, Carrara, VI, Das, D, Dondorp, AM, Humphreys, GS, Lee, SJ, Mayxay, M, McGready, R, Newton, PN, Nosten, F, Richmond, CL, Sibley, C, Smithuis, FM, Taylor, WR, Tran, TH, von Seidlein, L, White, NJ, Woodrow, CJ, Guerin, PJ, Stepniewska, K, Price, RN, AII - Infectious diseases, Intensive Care Medicine, Infectious diseases, APH - Global Health, and APH - Quality of Care

Subjects
Infectious Medicine, Plasmodium falciparum, wh_120, Infektionsmedicin, Severe anaemia, Parasitemia, wa_530, Antimalarials, Non-artemisinin-based therapy, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, parasitic diseases, qv_256, Humans, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, Malaria, Falciparum, Child, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Pooled analysis of individual patient data, Anemia, Public Health, Global Health, Social Medicine and Epidemiology, General Medicine, Artemisinin-based therapy, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Malaria, wc_750, Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Haemoglobin
Abstract

Background Plasmodium falciparum malaria is associated with anaemia-related morbidity, attributable to host, parasite and drug factors. We quantified the haematological response following treatment of uncomplicated P. falciparum malaria to identify the factors associated with malarial anaemia. Methods Individual patient data from eligible antimalarial efficacy studies of uncomplicated P. falciparum malaria, available through the WorldWide Antimalarial Resistance Network data repository prior to August 2015, were pooled using standardised methodology. The haematological response over time was quantified using a multivariable linear mixed effects model with nonlinear terms for time, and the model was then used to estimate the mean haemoglobin at day of nadir and day 7. Multivariable logistic regression quantified risk factors for moderately severe anaemia (haemoglobin < 7 g/dL) at day 0, day 3 and day 7 as well as a fractional fall ≥ 25% at day 3 and day 7. Results A total of 70,226 patients, recruited into 200 studies between 1991 and 2013, were included in the analysis: 50,859 (72.4%) enrolled in Africa, 18,451 (26.3%) in Asia and 916 (1.3%) in South America. The median haemoglobin concentration at presentation was 9.9 g/dL (range 5.0–19.7 g/dL) in Africa, 11.6 g/dL (range 5.0–20.0 g/dL) in Asia and 12.3 g/dL (range 6.9–17.9 g/dL) in South America. Moderately severe anaemia (Hb < 7g/dl) was present in 8.4% (4284/50,859) of patients from Africa, 3.3% (606/18,451) from Asia and 0.1% (1/916) from South America. The nadir haemoglobin occurred on day 2 post treatment with a mean fall from baseline of 0.57 g/dL in Africa and 1.13 g/dL in Asia. Independent risk factors for moderately severe anaemia on day 7, in both Africa and Asia, included moderately severe anaemia at baseline (adjusted odds ratio (AOR) = 16.10 and AOR = 23.00, respectively), young age (age < 1 compared to ≥ 12 years AOR = 12.81 and AOR = 6.79, respectively), high parasitaemia (AOR = 1.78 and AOR = 1.58, respectively) and delayed parasite clearance (AOR = 2.44 and AOR = 2.59, respectively). In Asia, patients treated with an artemisinin-based regimen were at significantly greater risk of moderately severe anaemia on day 7 compared to those treated with a non-artemisinin-based regimen (AOR = 2.06 [95%CI 1.39–3.05], p < 0.001). Conclusions In patients with uncomplicated P. falciparum malaria, the nadir haemoglobin occurs 2 days after starting treatment. Although artemisinin-based treatments increase the rate of parasite clearance, in Asia they are associated with a greater risk of anaemia during recovery.

Published
2022

38. Cardiovascular concentration–effect relationships of amodiaquine and its metabolite desethylamodiaquine: Clinical and preclinical studies

Author

Chan, Xin Hui S., primary, Chotsiri, Palang, additional, Capel, Rebecca A., additional, Pike, James, additional, Hanboonkunupakarn, Borimas, additional, Lee, Sue J., additional, Hanafiah, Maryam, additional, Win, Yan Naung, additional, Cremer, Maegan A., additional, Kiechel, Jean‐René, additional, Ogutu, Bernhards, additional, Taylor, Walter R. J., additional, Burton, Rebecca‐Ann B., additional, Tarning, Joel, additional, and White, Nicholas J., additional

Published
2022
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40. Quantifying primaquine effectiveness and improving adherence: a round table discussion of the APMEN Vivax Working Group

Author

Thriemer, Kamala, Bobogare, Albino, Ley, Benedikt, Gudo, Clarice Samo, Alam, Mohammad Shafiul, Anstey, Nick M., Ashley, Elizabeth, Baird, J. Kevin, Gryseels, Charlotte, Jambert, Elodie, Lacerda, Marcus, Laihad, Ferdinand, Marfurt, Jutta, Pasaribu, Ayodhia Pitaloka, Poespoprodjo, Jeanne Rini, Sutanto, Inge, Taylor, Walter R., van den Boogaard, Christel, Battle, Katherine E., Dysoley, Lek, Ghimire, Prakash, Hawley, Bill, Hwang, Jimee, Khan, Wasif Ali, Mudin, Rose Nani Binti, Sumiwi, Maria Endang, Ahmed, Rukhsana, Aktaruzzaman, M. M., Awasthi, Kiran Raj, Bardaji, Azucena, Bell, David, Boaz, Leonard, Burdam, Faustina Helen, Chandramohan, Daniel, Cheng, Qin, Chindawongsa, Keobouphaphone, Culpepper, Janice, Das, Santasabuj, Deray, Raffy, Desai, Meghna, Domingo, Gonzalo, Duoquan, Wang, Duparc, Stephan, Floranita, Rustini, Gerth-Guyette, Emily, Howes, Rosalind E., Hugo, Cecilia, Jagoe, George, Sariwati, Elvieda, Jhora, Sanya Tahmina, Jinwei, Wu, Karunajeewa, Harin, Kenangalem, Enny, Lal, Bibek Kumar, Landuwulang, Chandra, Le Perru, Emmanuel, Lee, Sang-Eun, Makita, Leo Sora, McCarthy, James, Mekuria, Asrat, Mishra, Neelima, Naket, Esau, Nambanya, Simone, Nausien, Johnny, Duc, Thang Ngo, Thi, Thuan Nguyen, Noviyanti, Rinitis, Pfeffer, Daniel, Qi, Gao, Rahmalia, Annisa, Rogerson, Stephen, Samad, Iriani, Sattabongkot, Jetsumon, Satyagraha, Ari, Shanks, Dennis, Sharma, Surender Nath, Sibley, Carol Hopkins, Sungkar, Ali, Syafruddin, Din, Talukdar, Arunansu, Tarning, Joel, ter Kuile, Feiko, Thapa, Suman, Theodora, Minerva, Huy, Tho Tran, Waramin, Edward, Waramori, Govert, Woyessa, Adugna, Wongsrichanalai, Chansuda, Xa, Nguyen Xuan, Yeom, Joon Sup, Hermawan, Lukas, Devine, Angela, Nowak, Spike, Jaya, Indra, Supargiyono, Supargiyono, Grietens, Koen Peeters, and Price, Ric N.

Published
2018
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41. Novel phenotypic assays for the detection of artemisinin-resistant Plasmodium falciparum malaria in Cambodia: in-vitro and ex-vivo drug-response studies

Author

Witkowski, Benoit, Amaratunga, Chanaki, Khim, Nimol, Sreng, Sokunthea, Chim, Pheaktra, Kim, Saorin, Lim, Pharath, Mao, Sivanna, Sopha, Chantha, Sam, Baramey, Anderson, Jennifer M, Duong, Socheat, Chuor, Char Meng, Taylor, Walter R J, Suon, Seila, Mercereau-Puijalon, Odile, Fairhurst, Rick M, and Menard, Didier

Published
2013
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43. Temporal distribution of Plasmodium falciparum recrudescence following artemisinin-based combination therapy: an individual participant data meta-analysis

Author

Dahal, Prabin, Simpson, Julie Anne, Abdulla, Salim, Achan, Jane, Adam, Ishag, Agarwal, Aarti, Allan, Richard, Anvikar, Anupkumar R., Ashley, Elizabeth A., Bassat, Quique, Borrmann, Steffen, Bousema, Teun, Bukirwa, Hasifa, Carrara, Verena, I, Corsi, Marco, D'Alessandro, Umberto, Davis, Timothy M. E., Deloron, Philippe, Desai, Meghna, Dimbu, Pedro Rafael, Djalle, Djibrine, Djimde, Abdoulaye, Dorsey, Grant, Drakeley, Chris J., Duparc, Stephan, Edstein, Michael D., Espie, Emmanuelle, Faiz, Abul, Falade, Catherine, Fanello, Caterina, Faucher, Jean-Francois, Faye, Babacar, Fortes, Filomeno de Jesus, Gadalla, Nahla B., Gaye, Oumar, Gil, J. Pedro, Gilayeneh, Julius, Greenwood, Brian, Grivoyannis, Anastasia, Hien, Tran Tinh, Hwang, Jimee, Janssens, Bart, Juma, Elizabeth, Kamugisha, Erasmus, Karema, Corine, Karunajeewa, Harin A., Kiechel, Jean R., Kironde, Fred, Kofoed, Poul-Erik, Kremsner, Peter G., Lee, Sue J., Marsh, Kevin, Mårtensson, Andreas, Mayxay, Mayfong, Menan, Herve, Mens, Petra, Mutabingwa, Theonest K., Ndiaye, Jean-Louis, Ngasala, Billy, Noedl, Harald, Nosten, Francois, Offianan, Andre Toure, Ogutu, Bernhards R., Olliaro, Piero L., Ouedraogo, Jean Bosco, Piola, Patrice, Plowe, Christopher, V, Plucinski, Mateusz M., Pratt, Oliver James, Premji, Zulfikarali, Ramharter, Michael, Rogier, Christophe, Vitare, Primum, Rombo, Lars, Rosenthal, Philip J., Sibley, Carol, Sirima, Sodiomon, Smithuis, Frank, Staedke, Sarah G., Sutanto, Inge, Talisuna, Ambrose Otau, Tarning, Joel, Taylor, Walter R. J., Temu, Emmanuel, Thriemer, Kamala, Thuy-Nhien, Nguyen, Udhayakumar, Venkatachalam, Ursing, Johan D., van Herp, Michel, van Lenthe, Marit, van Vugt, Michele, William, Yavo, Winnips, Cornelis, Zaloumis, Sophie, Zongo, Issaka, White, Nick J., Guerin, Philippe J., Stepniewska, Kasia, Price, Ric N., Arinaitwe, Emmanuel, and Group, WorldWide Antimalarial Resistance Network Methodology Study

Subjects
Infectious Medicine, Efficacy, Follow-up, Recrudescence, Artemether, Lumefantrine Drug Combination, Plasmodium falciparum, Infektionsmedicin, Distribution, Artemisinins, Malaria, Antimalarials, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Infectious Diseases, Recurrence, Child, Preschool, Humans, Parasitology, Artemether, Child
Abstract

Background The duration of trial follow-up affects the ability to detect recrudescent infections following anti-malarial treatment. The aim of this study was to explore the proportions of recrudescent parasitaemia as ascribed by genotyping captured at various follow-up time-points in treatment efficacy trials for uncomplicated Plasmodium falciparum malaria. Methods Individual patient data from 83 anti-malarial efficacy studies collated in the WorldWide Antimalarial Resistance Network (WWARN) repository with at least 28 days follow-up were available. The temporal and cumulative distributions of recrudescence were characterized using a Cox regression model with shared frailty on study-sites. Fractional polynomials were used to capture non-linear instantaneous hazard. The area under the density curve (AUC) of the constructed distribution was used to estimate the optimal follow-up period for capturing a P. falciparum malaria recrudescence. Simulation studies were conducted based on the constructed distributions to quantify the absolute overestimation in efficacy due to sub-optimal follow-up. Results Overall, 3703 recurrent infections were detected in 60 studies conducted in Africa (15,512 children aged 48 mg/kg total piperaquine (PIP) dose and 9% [95% CI 0–22%] in those treated with ≤ 48 mg/kg PIP dose. In absolute terms, the simulation study found that trials limited to 28 days follow-up following AL underestimated the risk of recrudescence by a median of 2.8 percentage points compared to day 63 estimates and those limited to 42 days following DP underestimated the risk of recrudescence by a median of 2.0 percentage points compared to day 42 estimates. The analysis was limited by few clinical trials following patients for longer than 42 days (9 out of 83 trials) and the imprecision of PCR genotyping which overcalls recrudescence in areas of higher transmission biasing the later distribution. Conclusions Restricting follow-up of clinical efficacy trials to day 28 for AL and day 42 for DP will miss a proportion of late recrudescent treatment failures but will have a modest impact in derived efficacy. The results highlight that as genotyping methods improve consideration should be given for trials with longer duration of follow-up to detect early indications of emerging drug resistance.

Published
2022

44. Cardiovascular concentration–effect relationships of amodiaquine and its metabolite desethylamodiaquine: Clinical and preclinical studies.

Author

Chan, Xin Hui S., Chotsiri, Palang, Capel, Rebecca A., Pike, James, Hanboonkunupakarn, Borimas, Lee, Sue J., Hanafiah, Maryam, Win, Yan Naung, Cremer, Maegan A., Kiechel, Jean‐René, Ogutu, Bernhards, Taylor, Walter R. J., Burton, Rebecca‐Ann B., Tarning, Joel, and White, Nicholas J.

Subjects
HEART beat, DIASTOLIC blood pressure, SYSTOLIC blood pressure, MALARIA prevention, KENYANS, BLOOD pressure, ATRIUMS (Architecture)
Abstract

Aims: Amodiaquine is a 4‐aminoquinoline used extensively for the treatment and prevention of malaria. Orally administered amodiaquine is largely converted to the active metabolite desethylamodiaquine. Amodiaquine can cause bradycardia, hypotension, and electrocardiograph QT interval prolongation, but the relationship of these changes to drug concentrations is not well characterized. Methods: We conducted a secondary analysis of a pharmacokinetic study of the cardiac safety of amodiaquine (10 mg base/kg/day over 3 days) in 54 Kenyan adults (≥18 years) with uncomplicated malaria. Nonlinear mixed effects modelling was used to assess amodiaquine and desethylamodiaquine concentration–effect relationships for vital sign (pulse rate, blood pressure) and electrocardiograph interval (QT, QRS, PR) outcomes. We also measured the spontaneous beating heart rate after cumulative dosing of amodiaquine and desethylamodiaquine in isolated mouse atrial preparations. Results: Amodiaquine and desethylamodiaquine caused concentration‐dependent mean decreases in pulse rate (1.9 beats/min per 100 nmol/L; 95% confidence interval: 1.5–2.4), supine systolic blood pressure (1.7 mmHg per 100 nmol/L; 1.2–2.1), erect systolic blood pressure (1.5 mmHg per 100 nmol/L; 1.0–2.0) and erect diastolic blood pressure (1.4 mmHg per 100 nmol/L; 1.0–1.7). The mean QT interval prolongation was 1.4 ms per 100 nmol/L irrespective of correction factor after adjustment for residual heart rate dependency. There was no significant effect of drug concentration on postural change in blood pressure or PR and QRS intervals. In mouse atria, the spontaneous beating rate was significantly reduced by amodiaquine (n = 6) and desethylamodiaquine (n = 8) at 3 μmol/L (amodiaquine: 10 ± 2%; desethylamodiaquine: 12 ± 3%) and 10 μmol/L (amodiaquine: 50 ± 7%; desethylamodiaquine: 46 ± 6%) concentrations with no significant difference in potency between the 2 compounds. Conclusion: Amodiaquine and desethylamodiaquine have concentration‐dependent effects on heart rate, blood pressure, and ventricular repolarization. [ABSTRACT FROM AUTHOR]

Published
2023
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47. In Vivo Parasitological Measures of Artemisinin Susceptibility

Author

Stepniewska, Kasia, Ashley, Elizabeth, Lee, Sue J., Anstey, Nicholas, Barnes, Karen I., Binh, Tran Quang, D'Alessandro, Umberto, Day, Nicholas P. J., de Vries, Peter J., Dorsey, Grant, Guthmann, Jean-Paul, Mayxay, Mayfong, Newton, Paul N., Olliaro, Piero, Osorio, Lyda, Price, Ric N., Rowland, Mark, Smithuis, Frank, Taylor, Walter R. J., Nosten, François, and White, Nicholas J.

Published
2010

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