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1. Randomized, open-label, phase 2a study to evaluate the contribution of artefenomel to the clinical and parasiticidal activity of artefenomel plus ferroquine in African patients with uncomplicated Plasmodium falciparum malaria

Author

Gansane, Adama, Lingani, Moussa, Yeka, Adoke, Nahum, Alain, Bouyou-Akotet, Marielle, Mombo-Ngoma, Ghyslain, Kaguthi, Grace, Barceló, Catalina, Laurijssens, Bart, Cantalloube, Cathy, Macintyre, Fiona, Djeriou, Elhadj, Jessel, Andreas, Bejuit, Raphaël, Demarest, Helen, Marrast, Anne Claire, Debe, Siaka, Tinto, Halidou, Kibuuka, Afizi, Nahum, Diolinda, Mawili-Mboumba, Denise Patricia, Zoleko-Manego, Rella, Mugenya, Irene, Olewe, Frederick, Duparc, Stephan, and Ogutu, Bernhards

Published
2023
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2. Operational effectiveness of tafenoquine and primaquine for the prevention of Plasmodium vivax recurrence in Brazil: a retrospective observational study

Author

Brito, Marcelo, Rufatto, Rosilene, Brito-Sousa, José Diego, Murta, Felipe, Sampaio, Vanderson, Balieiro, Patrícia, Baía-Silva, Djane, Castro, Vanessa, Alves, Brenda, Alencar, Aline, Duparc, Stephan, Grewal Daumerie, Penny, Borghini-Fuhrer, Isabelle, Jambert, Elodie, Peterka, Cássio, Edilson Lima, Francisco, Jr, Carvalho Maia, Leonardo, Lucena Cruz, Catherine, Maciele, Bruna, Vasconcelos, Mariana, Machado, Myrna, Augusto Figueira, Elder, Alcirley Balieiro, Antônio, Batista Pereira, Dhelio, and Lacerda, Marcus

Published
2024
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8. Tafenoquine co-administered with dihydroartemisinin–piperaquine for the radical cure of Plasmodium vivax malaria (INSPECTOR): a randomised, placebo-controlled, efficacy and safety study

Author

Sutanto, Inge, Soebandrio, Amin, Ekawati, Lenny L, Chand, Krisin, Noviyanti, Rintis, Satyagraha, Ari Winasti, Subekti, Decy, Santy, Yulia Widya, Crenna-Darusallam, Chelzie, Instiaty, Instiaty, Budiman, Waras, Prasetya, Catur Bidik, Lardo, Soroy, Elyazar, Iqbal, Duparc, Stephan, Cedar, Eve, Rolfe, Katie, Fernando, Disala, Berni, Alessandro, Jones, Siôn, Kleim, Jörg-Peter, Fletcher, Kim, Sharma, Hema, Martin, Ana, Taylor, Maxine, Goyal, Navin, Green, Justin A, Tan, Lionel K, and Baird, J Kevin

Published
2023
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9. Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries

Author

Vignier, Nicolas, Bouchaud, Olivier, Angheben, Andrea, Bottieau, Emmanuel, Calleri, Guido, Salas-Coronas, Joaquín, Martin, Charlotte, Ramos, José Manuel, Mechain, Matthieu, Rapp, Christophe, Nothdurft, Hans-Dieter, Velasco, Maria, Bardají, Azucena, Rojo-Marcos, Gerardo, Visser, Leo G., Hatz, Christoph, Bisoffi, Zeno, Jelinek, Tomas, Duparc, Stephan, Bourhis, Yann, Tommasini, Silva, Iannucelli, Maurizio, Bacchieri, Antonella, Mattera, Giovan Giuseppe, Merlo Pich, Emilio, and Behrens, Ronald H.

Published
2021
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10. Randomized Placebo-Controlled Trial Evaluating the Ophthalmic Safety of Single-Dose Tafenoquine in Healthy Volunteers

Author

Ackert, Jessica, Mohamed, Khadeeja, Slakter, Jason S., El-Harazi, Sherif, Berni, Alessandro, Gevorkyan, Hakop, Hardaker, Elizabeth, Hussaini, Azra, Jones, Siôn W., Koh, Gavin C. K. W., Patel, Jyoti, Rasmussen, Scott, Kelly, Deborah S., Barañano, David E., Thompson, John T., Warren, Keith A., Sergott, Robert C., Tonkyn, John, Wolstenholme, Allen, Coleman, Hanna, Yuan, Alex, Duparc, Stephan, and Green, Justin A.

Published
2019
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11. Efficacy and Safety of Fosmidomycin–Piperaquine as Nonartemisinin-Based Combination Therapy for Uncomplicated Falciparum Malaria : A Single-Arm, Age De-escalation Proof-of-Concept Study in Gabon

Author

Mombo-Ngoma, Ghyslain, Remppis, Jonathan, Sievers, Moritz, Manego, Rella Zoleko, Endamne, Lilian, Kabwende, Lumeka, Veletzky, Luzia, Nguyen, The Trong, Groger, Mirjam, Lötsch, Felix, Mischlinger, Johannes, Flohr, Lena, Kim, Johanna, Cattaneo, Chiara, Hutchinson, David, Duparc, Stephan, Moehrle, Joerg, Velavan, Thirumalaisamy P., Lell, Bertrand, Ramharter, Michael, Adegnika, Ayola Akim, Mordmüller, Benjamin, and Kremsner, and Peter G.

Published
2018

12. A Randomized Trial Evaluating the Prophylactic Activity of DSM265 Against Preerythrocytic Plasmodium falciparum Infection During Controlled Human Malarial Infection by Mosquito Bites and Direct Venous Inoculation

Author

Murphy, Sean C., Duke, Elizabeth R., Shipman, Kelly J., Jensen, Ryan L., Fong, Youyi, Ferguson, Sue, Janes, Holly E., Gillespie, Kevin, Seilie, Annette M., Hanron, Amelia E., Rinn, Laurie, Fishbaugher, Matthew, VonGoedert, Tracie, Fritzen, Emma, Kappe, Stefan H., Chang, Ming, Sousa, Jason C., Marcsisin, Sean R., Chalon, Stephan, Duparc, Stephan, Kerr, Nicola, Möhrle, Jörg J., Andenmatten, Nicole, Rueckle, Thomas, and Kublin, James G.

Published
2018

14. Antimalarial activity of single-dose DSM265, a novel plasmodium dihydroorotate dehydrogenase inhibitor, in patients with uncomplicated Plasmodium falciparum or Plasmodium vivax malaria infection: a proof-of-concept, open-label, phase 2a study

Author

Llanos-Cuentas, Alejandro, Casapia, Martin, Chuquiyauri, Raúl, Hinojosa, Juan-Carlos, Kerr, Nicola, Rosario, Maria, Toovey, Stephen, Arch, Robert H, Phillips, Margaret A, Rozenberg, Felix D, Bath, Jade, Ng, Caroline L, Cowell, Annie N, Winzeler, Elizabeth A, Fidock, David A, Baker, Mark, Möhrle, Jörg J, Hooft van Huijsduijnen, Rob, Gobeau, Nathalie, Araeipour, Nada, Andenmatten, Nicole, Rückle, Thomas, and Duparc, Stephan

Published
2018
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17. Pyronaridine-artesunate real-world safety, tolerability, and effectiveness in malaria patients in 5 African countries: A single-arm, open-label, cohort event monitoring study

Author

Tona Lutete, Gaston, Mombo-Ngoma, Ghyslain, Assi, Serge-Brice, Bigoga, Jude D., Koukouikila-Koussounda, Felix, Ntamabyaliro, Nsengi Y., Ntoumi, Francine, Agnandji, Selidji T., Groger, Mirjam, Shin, Jangsik, Borghini-Fuhrer, Isabelle, Arbe-Barnes, Sarah, Allen, Stephen J., Kremsner, Peter G., Miller, Robert, Duparc, Stephan, and Ramharter, Michael

Subjects
Antimalarials -- Dosage and administration -- Patient outcomes, Drug therapy, Combination -- Methods -- Patient outcomes, Malaria -- Drug therapy -- Patient outcomes, Biological sciences
Abstract

Background In Phase II/III randomized controlled clinical trials for the treatment of acute uncomplicated malaria, pyronaridine-artesunate demonstrated high efficacy and a safety profile consistent with that of comparators, except that asymptomatic, mainly mild-to-moderate transient increases in liver aminotransferases were reported for some patients. Hepatic safety, tolerability, and effectiveness have not been previously assessed under real-world conditions in Africa. Methods and findings This single-arm, open-label, cohort event monitoring study was conducted at 6 health centers in Cameroon, Democratic Republic of Congo, Gabon, Ivory Coast, and Republic of Congo between June 2017 and April 2019. The trial protocol as closely as possible resembled real-world clinical practice for the treatment of malaria at the centers. Eligible patients were adults or children of either sex, weighing at least 5 kg, with acute uncomplicated malaria who did not have contraindications for pyronaridine-artesunate treatment as per the summary of product characteristics. Patients received fixed-dose pyronaridine-artesunate once daily for 3 days, dosed by body weight, without regard to food intake. A tablet formulation was used in adults and adolescents and a pediatric granule formulation in children and infants under 20 kg body weight. The primary outcome was the hepatic event incidence, defined as the appearance of the clinical signs and symptoms of hepatotoxicity confirmed by a >2x rise in alanine aminotransferase/aspartate aminotransferase (ALT/AST) versus baseline in patients with baseline ALT/AST >2x the upper limit of normal (ULN). As a secondary outcome, this was assessed in patients with ALT/AST >2x ULN prior to treatment versus a matched cohort of patients with normal baseline ALT/AST. The safety population comprised 7,154 patients, of mean age 13.9 years (standard deviation (SD) 14.6), around half of whom were male (3,569 [49.9%]). Patients experienced 8,560 malaria episodes; 158 occurred in patients with baseline ALT/AST elevations >2xULN. No protocol-defined hepatic events occurred following pyronaridine-artesunate treatment of malaria patients with or without baseline hepatic dysfunction. Thus, no cohort comparison could be undertaken. Also, as postbaseline clinical chemistry was only performed where clinically indicated, postbaseline ALT/AST levels were not systematically assessed for all patients. Adverse events of any cause occurred in 20.8% (1,490/7,154) of patients, most frequently pyrexia (5.1% [366/7,154]) and vomiting (4.2% [303/7,154]). Adjusting for Plasmodium falciparum reinfection, clinical effectiveness at day 28 was 98.6% ([7,369/7,746] 95% confidence interval (CI) 98.3 to 98.9) in the per-protocol population. There was no indication that comorbidities or malnutrition adversely affected outcomes. The key study limitation was that postbaseline clinical biochemistry was only evaluated when clinically indicated. Conclusions Pyronaridine-artesunate had good tolerability and effectiveness in a representative African population under conditions similar to everyday clinical practice. These findings support pyronaridine-artesunate as an operationally useful addition to the management of acute uncomplicated malaria. Trial registration ClinicalTrials.gov NCT03201770., Author(s): Gaston Tona Lutete 1, Ghyslain Mombo-Ngoma 2,3,4, Serge-Brice Assi 5, Jude D. Bigoga 6, Felix Koukouikila-Koussounda 7, Nsengi Y. Ntamabyaliro 1, Francine Ntoumi 3,7, Selidji T. Agnandji 2,3, Mirjam [...]

Published
2021
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20. Safety and efficacy of four drug regimens versus standard-of-care for the treatment of symptomatic outpatients with COVID-19: A randomised, open-label, multi-arm, phase 2 clinical trial

Author

Chandiwana, Nomathemba, primary, Kruger, Chelsea, additional, Johnstone, Hilary, additional, Chughlay, Mohamed Farouk, additional, Ju, Chung, additional, Kim, Byungsu, additional, Dineka, Yengiwe, additional, Arbe-Barnes, Sarah, additional, Miller, Robert, additional, Owen, Andrew, additional, Hill, Andrew, additional, Windgassen, Daniel, additional, Abla, Nada, additional, Marrast, Anne Claire, additional, Duparc, Stephan, additional, and Francois Venter, Willem Daniel, additional

Published
2022
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22. Additional file 1 of Randomized, open-label, phase 2a study to evaluate the contribution of artefenomel to the clinical and parasiticidal activity of artefenomel plus ferroquine in African patients with uncomplicated Plasmodium falciparum malaria

Author

Gansane, Adama, Lingani, Moussa, Yeka, Adoke, Nahum, Alain, Bouyou-Akotet, Marielle, Mombo-Ngoma, Ghyslain, Kaguthi, Grace, Barceló, Catalina, Laurijssens, Bart, Cantalloube, Cathy, Macintyre, Fiona, Djeriou, Elhadj, Jessel, Andreas, Bejuit, Raphaël, Demarest, Helen, Marrast, Anne Claire, Debe, Siaka, Tinto, Halidou, Kibuuka, Afizi, Nahum, Diolinda, Mawili-Mboumba, Denise Patricia, Zoleko-Manego, Rella, Mugenya, Irene, Olewe, Frederick, Duparc, Stephan, and Ogutu, Bernhards

Abstract

Additional file 1: Study protocol.

Published
2023
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23. Additional file 2 of Randomized, open-label, phase 2a study to evaluate the contribution of artefenomel to the clinical and parasiticidal activity of artefenomel plus ferroquine in African patients with uncomplicated Plasmodium falciparum malaria

Author

Gansane, Adama, Lingani, Moussa, Yeka, Adoke, Nahum, Alain, Bouyou-Akotet, Marielle, Mombo-Ngoma, Ghyslain, Kaguthi, Grace, Barceló, Catalina, Laurijssens, Bart, Cantalloube, Cathy, Macintyre, Fiona, Djeriou, Elhadj, Jessel, Andreas, Bejuit, Raphaël, Demarest, Helen, Marrast, Anne Claire, Debe, Siaka, Tinto, Halidou, Kibuuka, Afizi, Nahum, Diolinda, Mawili-Mboumba, Denise Patricia, Zoleko-Manego, Rella, Mugenya, Irene, Olewe, Frederick, Duparc, Stephan, and Ogutu, Bernhards

Abstract

Additional file 2: Clinical trial simulation to determine the dose and sample sizes.

Published
2023
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24. Additional file 5 of Randomized, open-label, phase 2a study to evaluate the contribution of artefenomel to the clinical and parasiticidal activity of artefenomel plus ferroquine in African patients with uncomplicated Plasmodium falciparum malaria

Author

Gansane, Adama, Lingani, Moussa, Yeka, Adoke, Nahum, Alain, Bouyou-Akotet, Marielle, Mombo-Ngoma, Ghyslain, Kaguthi, Grace, Barceló, Catalina, Laurijssens, Bart, Cantalloube, Cathy, Macintyre, Fiona, Djeriou, Elhadj, Jessel, Andreas, Bejuit, Raphaël, Demarest, Helen, Marrast, Anne Claire, Debe, Siaka, Tinto, Halidou, Kibuuka, Afizi, Nahum, Diolinda, Mawili-Mboumba, Denise Patricia, Zoleko-Manego, Rella, Mugenya, Irene, Olewe, Frederick, Duparc, Stephan, and Ogutu, Bernhards

Abstract

Additional file 5. Supplementary tables and figures.

Published
2023
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25. Additional file 4 of Randomized, open-label, phase 2a study to evaluate the contribution of artefenomel to the clinical and parasiticidal activity of artefenomel plus ferroquine in African patients with uncomplicated Plasmodium falciparum malaria

Author

Gansane, Adama, Lingani, Moussa, Yeka, Adoke, Nahum, Alain, Bouyou-Akotet, Marielle, Mombo-Ngoma, Ghyslain, Kaguthi, Grace, Barceló, Catalina, Laurijssens, Bart, Cantalloube, Cathy, Macintyre, Fiona, Djeriou, Elhadj, Jessel, Andreas, Bejuit, Raphaël, Demarest, Helen, Marrast, Anne Claire, Debe, Siaka, Tinto, Halidou, Kibuuka, Afizi, Nahum, Diolinda, Mawili-Mboumba, Denise Patricia, Zoleko-Manego, Rella, Mugenya, Irene, Olewe, Frederick, Duparc, Stephan, and Ogutu, Bernhards

Abstract

Additional file 4: Exposure–response pharmacokinetic/pharmacodynamic analysis.

Published
2023
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26. 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

31. Effectiveness of pyronaridine-artesunate against Plasmodium malariae, Plasmodium ovale spp, and mixed-Plasmodium infections: a post-hoc analysis of the CANTAM-Pyramax trial

Author

Groger, Mirjam, primary, Tona Lutete, Gaston, additional, Mombo-Ngoma, Ghyslain, additional, Ntamabyaliro, Nsengi Y, additional, Kahunu Mesia, Gauthier, additional, Muena Mujobu, Trésor Bodjick, additional, Dimessa Mbadinga, Lia Betty, additional, Zoleko Manego, Rella, additional, Egger-Adam, Diane, additional, Borghini-Fuhrer, Isabelle, additional, Shin, Jangsik, additional, Miller, Robert, additional, Arbe-Barnes, Sarah, additional, Duparc, Stephan, additional, and Ramharter, Michael, additional

Published
2022
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32. Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, double-blind, randomised, phase 2b dose-selection study

Author

Llanos-Cuentas, Alejandro, Lacerda, Marcus V, Rueangweerayut, Ronnatrai, Krudsood, Srivicha, Gupta, Sandeep K, Kochar, Sanjay K, Arthur, Preetam, Chuenchom, Nuttagarn, Möhrle, Jörg J, Duparc, Stephan, Ugwuegbulam, Cletus, Kleim, Jörg-Peter, Carter, Nick, Green, Justin A, and Kellam, Lynda

Published
2014
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33. A pharmacometrics approach to assess the feasibility of capillary microsampling to replace venous sampling in clinical studies: Tafenoquine case study.

Author

Bachhav, Sagar S., Taylor, Maxine, Martin, Ana, Green, Justin A., Duparc, Stephan, Rolfe, Katie, Sharma, Hema, Tan, Lionel K., and Goyal, Navin

Subjects
BIOAVAILABILITY, CAPILLARIES, BLOOD volume, CORD blood, SAMPLING (Process), PHARMACOKINETICS, BODY weight
Abstract

Aim: Microsampling has the advantage of smaller blood sampling volume and suitability in vulnerable populations compared to venous sampling in clinical pharmacokinetics studies. Current regulatory guidance requires correlative studies to enable microsampling as a technique. A post hoc population pharmacokinetic (POPPK) approach was utilized to investigate blood capillary microsampling as an alternative to venous sampling. Methods: Pharmacokinetic data from microsampling and venous sampling techniques during a paediatric study evaluating tafenoquine, a single‐dose antimalarial for P. vivax, were used. Separate POPPK models were developed and validated based on goodness of fit and visual predictive checks, with pharmacokinetic data obtained via each sampling technique. Results: Each POPPK model adequately described tafenoquine pharmacokinetics using a two‐compartment model with body weight based on allometric scaling of clearance and volume of distribution. Tafenoquine pharmacokinetic parameter estimates including clearance (3.4 vs 3.7 L/h) were comparable across models with slightly higher interindividual variability (38.3% vs 27%) in capillary microsampling‐based data. A bioavailability/bioequivalence comparison demonstrated that the point estimate (90% CI) of capillary microsample versus venous sample model‐based individual post hoc estimates for area under the concentration‐time curve from time zero to infinity (AUC0‐inf) (100.7%, 98.0‐103.5%) and Cmax (79.7%, 76.9‐82.5%) met the 80‐125% and 70‐143% criteria, respectively. Overall, both POPPK models led to the same dose regimen recommendations across weight bins based on achieving target AUC. Conclusions: This analysis demonstrated that a POPPK approach can be employed to assess the performance of alternative pharmacokinetic sampling techniques. This approach provides a robust solution in scenarios where variability in pharmacokinetic data collected via venous sampling and microsampling may not result in a strong linear relationship. The findings also established that microsampling techniques may replace conventional venous sampling methods. [ABSTRACT FROM AUTHOR]

Published
2023
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34. 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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37. 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

38. Impact of the malaria comprehensive case management programme in Odisha, India

Author

Pradhan, Madan M., primary, Pradhan, Sreya, additional, Dutta, Ambarish, additional, Shah, Naman K., additional, Valecha, Neena, additional, Joshi, Pyare L., additional, Pradhan, Khageshwar, additional, Grewal Daumerie, Penny, additional, Banerji, Jaya, additional, Duparc, Stephan, additional, Mendis, Kamini, additional, Sharma, Surya K., additional, Murugasampillay, Shiva, additional, and Anvikar, Anupkumar R., additional

Published
2022
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39. Malaria prevalence among young infants in different transmission settings, Africa

Author

Ceesay, Serign J., Koivogui, Lamine, Nahum, Alain, Taal, Makie Abdoulie, Okebe, Joseph, Affara, Muna, Kaman, Lama Eugene, Bohissou, Francis, Agbowai, Carine, Tolno, Benoit Gniouma, Amambua-Ngwa, Alfred, Bangoura, NFaly, Ahounou, Daniel, Muhammad, Abdul Khalie, Duparc, Stephan, Hamed, Kamal, Ubben, David, Bojang, Kalifa, Achan, Jane, and D'Alessandro, Umberto

Subjects
Health
Abstract

Infants are thought to be protected against malaria during the first 6 months of life, largely due to the transfer of maternal antibodies (1) and the presence of fetal hemoglobin [...]

Published
2015
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40. A Simplified Intravenous Artesunate Regimen for Severe Malaria—Reply

Author

Kremsner, Peter Gottfried, Taylor, Terrie, Issifou, Saadou, Kombila, Maryvonne, Chimalizeni, Yamikani, Kawaza, Kondwana, Akotet, Marielle K. Bouyou, Duscha, Mattias, Mordmüller, Benjamin, Kösters, Katrin, Humberg, Alexander, Miller, R. Scott, Weina, Peter, Duparc, Stephan, Möhrle, Jörg, Kun, Jürgen F. J., Planche, Tim, Teja-Isavadharm, Paktiya, Simpson, Julie Anne, Köhler, Carsten, and Krishna, Sanjeev

Published
2012
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42. Tafenoquine exposure assessment, safety, and relapse prevention efficacy in children with Plasmodium vivax malaria: open-label, single-arm, non-comparative, multicentre, pharmacokinetic bridging, phase 2 trial

Author

Vélez, Iván D, primary, Hien, Tran T, additional, Green, Justin A, additional, Martin, Ana, additional, Sharma, Hema, additional, Rousell, Victoria M, additional, Breton, John J, additional, Ernest, Terry B, additional, Rolfe, Katie, additional, Taylor, Maxine, additional, Mohamed, Khadeeja, additional, Jones, Siôn W, additional, Chau, Nguyen Hoang, additional, Hoa, Nhu Thi, additional, Duparc, Stephan, additional, Tan, Lionel K, additional, and Goyal, Navin, additional

Published
2022
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45. Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial

Author

Tshefu, Antoinette K, Gaye, Oumar, Kayentao, Kassoum, Thompson, Ricardo, Bhatt, Kirana M, Sesay, Sanie SS, Bustos, Dorina G, Tjitra, Emiliana, Bedu-Addo, George, Borghini-Fuhrer, Isabelle, Duparc, Stephan, Shin, Chang Sik, and Fleckenstein, Lawrence

Published
2010
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46. Plasmodium vivaxin Children: Hidden Burden and Conspicuous Challenges, a Narrative Review

Author

Drysdale, Myriam, Tan, Lionel, Martin, Ana, Fuhrer, Isabelle Borghini, Duparc, Stephan, and Sharma, Hema

Abstract

There has been progress towards decreasing malaria prevalence globally; however, Plasmodium vivaxhas been less responsive to elimination efforts compared with Plasmodium falciparum. P. vivaxmalaria remains a serious public health concern in regions where it is the dominant species (South and South-East Asia, the Eastern Mediterranean region, and South America) and is increasingly recognized for its contribution to overall morbidity and mortality worldwide. The incidence of P. vivaxdecreases with increasing age owing to rapidly acquired clinical immunity and there is a disproportionate burden of P. vivaxin infants and children, who remain highly vulnerable to severe disease, recurrence, and anemia with associated developmental impacts. Diagnosis is sometimes difficult owing to the sensitivity of diagnostic tests to detect low levels of parasitemia. Additionally, the propensity of P. vivaxto relapse following reactivation of dormant hypnozoites in the liver contributes to disease recurrence in infants and children, and potentiates morbidity and transmission. The 8-aminoquinolines, primaquine and tafenoquine, provide radical cure (relapse prevention). However, the risk of hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency necessitates testing prior to administration of 8-aminoquinolines, which has limited their uptake. Additional challenges include lack of availability of pediatric dose formulations and problems with adherence to primaquine owing to the length of treatment recommended. A paucity of data and studies specific to pediatric P. vivaxmalaria impacts the ability to deliver targeted interventions. It is imperative that P. vivaxin infants and children be the focus of future research, control initiatives, and anti-malarial drug development.

Published
2023
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47. Additional file 2 of Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries

Author

Vignier, Nicolas, Bouchaud, Olivier, Angheben, Andrea, Bottieau, Emmanuel, Calleri, Guido, Salas-Coronas, Joaquín, Martin, Charlotte, Ramos, José Manuel, Mechain, Matthieu, Rapp, Christophe, Hans-Dieter Nothdurft, Velasco, Maria, Bardají, Azucena, Rojo-Marcos, Gerardo, Visser, Leo G., Hatz, Christoph, Bisoffi, Zeno, Jelinek, Tomas, Duparc, Stephan, Bourhis, Yann, Tommasini, Silva, Iannucelli, Maurizio, Bacchieri, Antonella, Mattera, Giovan Giuseppe, Pich, Emilio Merlo, and Behrens, Ronald H.

Subjects
parasitic diseases
Abstract

Additional file 2. Baseline biological results—safety registry of malaria patients treated with artenimol–piperaquine.

Published
2021
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48. Additional file 5 of Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries

Author

Vignier, Nicolas, Bouchaud, Olivier, Angheben, Andrea, Bottieau, Emmanuel, Calleri, Guido, Salas-Coronas, Joaquín, Martin, Charlotte, Ramos, José Manuel, Mechain, Matthieu, Rapp, Christophe, Hans-Dieter Nothdurft, Velasco, Maria, Bardají, Azucena, Rojo-Marcos, Gerardo, Visser, Leo G., Hatz, Christoph, Bisoffi, Zeno, Jelinek, Tomas, Duparc, Stephan, Bourhis, Yann, Tommasini, Silva, Iannucelli, Maurizio, Bacchieri, Antonella, Mattera, Giovan Giuseppe, Pich, Emilio Merlo, and Behrens, Ronald H.

Subjects
sense organs
Abstract

Additional file 5. Factors associated with the change in Alanine amino-transferase (ALAT), Aspartate amino-transferase (ASAT) and creatinin from baseline to the final treatment day.

Published
2021
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49. Additional file 1 of Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries

Author

Vignier, Nicolas, Bouchaud, Olivier, Angheben, Andrea, Bottieau, Emmanuel, Calleri, Guido, Salas-Coronas, Joaquín, Martin, Charlotte, Ramos, José Manuel, Mechain, Matthieu, Rapp, Christophe, Hans-Dieter Nothdurft, Velasco, Maria, Bardají, Azucena, Rojo-Marcos, Gerardo, Visser, Leo G., Hatz, Christoph, Bisoffi, Zeno, Jelinek, Tomas, Duparc, Stephan, Bourhis, Yann, Tommasini, Silva, Iannucelli, Maurizio, Bacchieri, Antonella, Mattera, Giovan Giuseppe, Pich, Emilio Merlo, and Behrens, Ronald H.

Abstract

Additional file 1. Illnesses and symptoms at Visit 1 by System Organ Class and Preferred Term—safety registry of malaria patients treated with artenimol–piperaquine.

Published
2021
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50. Additional file 3 of Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries

Author

Vignier, Nicolas, Bouchaud, Olivier, Angheben, Andrea, Bottieau, Emmanuel, Calleri, Guido, Salas-Coronas, Joaquín, Martin, Charlotte, Ramos, José Manuel, Mechain, Matthieu, Rapp, Christophe, Hans-Dieter Nothdurft, Velasco, Maria, Bardají, Azucena, Rojo-Marcos, Gerardo, Visser, Leo G., Hatz, Christoph, Bisoffi, Zeno, Jelinek, Tomas, Duparc, Stephan, Bourhis, Yann, Tommasini, Silva, Iannucelli, Maurizio, Bacchieri, Antonella, Mattera, Giovan Giuseppe, Pich, Emilio Merlo, and Behrens, Ronald H.

Subjects
parasitic diseases
Abstract

Additional file 3. Overview of adverse events (AE) and serious adverse event (SAE) other than adverse event of special interest (AESI).

Published
2021
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