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3. A multinational Delphi consensus to end the COVID-19 public health threat

Author

Lazarus, J. V., Romero, D., Kopka, C. J., Karim, S. A., Abu-Raddad, L. J., Almeida, G., Baptista-Leite, R., Barocas, J. A., Barreto, M. L., Bar-Yam, Y., Bassat, Q., Batista, C., Bazilian, M., Chiou, S. -T., del Rio, C., Dore, G. J., Gao, G. F., Gostin, L. O., Hellard, M., Jimenez, J. L., Kang, G., Lee, N., Maticic, M., Mckee, M., Nsanzimana, S., Oliu-Barton, M., Pradelski, B., Pyzik, O., Rabin, K., Raina, S., Rashid, S. F., Rathe, M., Saenz, R., Singh, S., Trock-Hempler, M., Villapol, S., Yap, P., Binagwaho, A., Kamarulzaman, A., El-Mohandes, A., Barreto, M., Abdulla, S., Addleman, S., Aghayeva, G., Agius, R., Ahmed, M., Ramy, M. A., Aide, P., Aleman, S., Alfred, J. -P., Ali, S., Aliaga, J., Aloudat, T., Alqahtani, S. A., Al-Salman, J., Amuasi, J. H., Agrawal, A., Anwar, W., Araujo-Jorge, T., Artaza, O., Asadi, L., Awuku, Y., Baker, M., Barberia, L., Bascolo, E., Belcher, P., Bell, L., Benzaken, A., Bergholtz, E., Bhadelia, N., Bhan, A., Bilodeau, S., Bitran, R., Bluyssen, P., Bosman, A., Bozza, F. A., Brinkmann, M. M., Brown, A., Mellado, B., Bukusi, E., Bullen, C., Buonanno, G., Burgess, R., Butler, M., Byakika-Kibwika, P., Cabieses, B., Carlsson, G., Cascini, Fidelia, Chabala, C., Chakroun, M., Cheng, K. K., Chetty, A., Chumachenko, D., Consalves, G., Conway Morris, A., Cordie, A., Corrah, T., Crabtree-Ramirez, B., Dashdorj, N., Davidovitch, N., de Souza, L. E., Dhariwal, A. C., Druica, E., Ergonul, O., Erondu, N. A., Essar, M. Y., Ewing, A., Fanjul, G., Feierstein, D., Feigl-Ding, E., Figueroa, R., Figueroa, J. P., Fisher, D., Flores, W., Forero-Pena, D. A., Frumkin, H., Gamkrelidze, A., Gandhi, M., Garcia, P., Garcia-Basteiro, A. L., Garcia-Sastre, A., Garg, S., Gbeasor-Komlanvi, F. A., Gershenson, C., Gilada, I., Giovanella, L., Gonzalez, M., Green, M. S., Greenhalgh, T., Griffin, P., Griffin, S., Grinsztejn, B., Anand, T., Guerra, G., Guinto, R., Gujski, M., Guner, R., Hamdy, A., Hancean, M. -G., Haniffa, A., Hartigan-Go, K. Y., Hassan, H. K., Hay, S. I., Heino, M. T. J., Hel, Z., Hotez, P., Hu, J., Hukic, M., Ijsselmuiden, C., Iroko, D., Iskarous, M., Izugbara, C., Jacobs, C., Jadad, A. R., Jehan, F., Jordan, A., Jroundi, I., Kain, K., Kamberi, F., Karamov, E., Karan, A., Katz, R., Katzourakis, A., Kazembe, A., Khamis, F., Khamzayev, K., Khanyola, J., Khunti, K., Kiguli-Malwadde, E., Kim, W. J., Kirenga, B. J., Klimovsky, D., Kmush, B. L., Knaul, F., Kogevinas, M., Kristensen, F., Kumar, D., Kumar, R., Kvalsvig, A., Lacerda, M. V., Lal, A., Lawton, T., Lemery, J., Leonardi, A. J., Li, Y., Lottvall, J., Lounis, M., Maceira, D., Macintyre, C. R., Madani, A., Magiorkinis, G., Malekzadeh, R., Choisy, M., Marcelin, J. R., Marks, G. B., Marr, L., Marrazzo, J., Martina, A., Martin-Moreno, J. M., Mateos, C., Mayxay, M., Mazarati, J. B., Mboup, S., Mcdonald, J., Mcmillan, F., Mechili, E., Medici, A., Davis, S. L. M., Meier, P., Memish, Z. A., Menon, J., Menon, P., Mesiano-Crookston, J., Michie, S., Mikolasevic, I., Milicevic, O., Mishra, A. K., Mohamed, R., Mokdad, A. H., Monroy-Valle, M., Morawska, L., Moschos, S. A., Motawea, K., Mousavi, S. H., Mumtaz, G., Munene, P. K., Munoz Almagro, C., Muriuki, J., Muyingo, S., Naniche, D., Naylor, C. D., Ndembi, N., Nemec, J., Nesteruk, I., Ngaruiya, C., Nguyen, H., Nikolova, D., Nitzan, D., Norheim, O., Noushad, M., Ntoumi, F., Nyborg, G. A., Ochodo, E., Odabasi, Z., Okwen, M. P., Olivia, K., Ong, D. S. Y., Opara, I., Orozco, M., Oshitani, H., Pagel, C., Pai, M., Palsdottir, B., Papatheodoridis, G., Paraskevis, D., Leigh, J. P., Pecoul, B., Peichl, A., Perez-Then, E., Duc, P. P., Philippe, C., Pineda Rojas, A., Pladsen, C., Pozniak, A., Quiroga, R., Qureshi, H., Rampal, S., Ranney, M., Rathe, L., Ratzan, S., Raventos, H., Rees, H., Reis, R., Ricciardi, Walter, Rizk, N., Robalo, M., Robertson, E., Robinson, L., Rokx, C., Ros, T., Rottingen, J. -A., Rubin, M., Ruxrungtam, K., Sadirova, S., Saha, S., Salgado, N., Sanchez, L., Sangaramoorthy, T., Santamaria-Ulloa, C., Santos, R., Sawaf, B., Schneider, M. F., Schooley, R. T., Sener, A., Sepulveda, J., Shah, J., Shibani, M., Shoib, S., Sikazwe, I., Simaitis, A., Gill, A. S., Skhvitaridze, N., Sokolovic, M., Solomon, R., Solorzano, X., Springer, S. A., Srol, J., Staines, A., Stelfox, H. T., Strathdee, S., Sulaiman, L. H., Sutton, B., Svanaes, D., Swed, S., Sypsa, V., Sorensen, K., Tajudeen, R., Tan, A., Tang, J., Tanner, M., Sethi, T., Temmerman, M., Than, K. K., Tinto, H., Tometissi, S. P., Torres, I., Tshering, K. P., Tsiodras, S., Tsofa, B., Vahlne, A., Vargas, J. R., Bernal, I. D. V., Ventura, D., Vilasanjuan, R., Vipond, J., Wamala-Andersson, S., Wargocki, P., West, R., Weyand, A., White, T. M., Wolff, G., Yao, M., Yates, C. A., Yeboah, G., Yee-Sin, L., Yi, S., Teo, Y. -Y., Yong, P., Zamora-Mesia, V., Ovrehus, A., Cascini F. (ORCID:0000-0001-6499-0734), Ricciardi W. (ORCID:0000-0002-5655-688X), Lazarus, J. V., Romero, D., Kopka, C. J., Karim, S. A., Abu-Raddad, L. J., Almeida, G., Baptista-Leite, R., Barocas, J. A., Barreto, M. L., Bar-Yam, Y., Bassat, Q., Batista, C., Bazilian, M., Chiou, S. -T., del Rio, C., Dore, G. J., Gao, G. F., Gostin, L. O., Hellard, M., Jimenez, J. L., Kang, G., Lee, N., Maticic, M., Mckee, M., Nsanzimana, S., Oliu-Barton, M., Pradelski, B., Pyzik, O., Rabin, K., Raina, S., Rashid, S. F., Rathe, M., Saenz, R., Singh, S., Trock-Hempler, M., Villapol, S., Yap, P., Binagwaho, A., Kamarulzaman, A., El-Mohandes, A., Barreto, M., Abdulla, S., Addleman, S., Aghayeva, G., Agius, R., Ahmed, M., Ramy, M. A., Aide, P., Aleman, S., Alfred, J. -P., Ali, S., Aliaga, J., Aloudat, T., Alqahtani, S. A., Al-Salman, J., Amuasi, J. H., Agrawal, A., Anwar, W., Araujo-Jorge, T., Artaza, O., Asadi, L., Awuku, Y., Baker, M., Barberia, L., Bascolo, E., Belcher, P., Bell, L., Benzaken, A., Bergholtz, E., Bhadelia, N., Bhan, A., Bilodeau, S., Bitran, R., Bluyssen, P., Bosman, A., Bozza, F. A., Brinkmann, M. M., Brown, A., Mellado, B., Bukusi, E., Bullen, C., Buonanno, G., Burgess, R., Butler, M., Byakika-Kibwika, P., Cabieses, B., Carlsson, G., Cascini, Fidelia, Chabala, C., Chakroun, M., Cheng, K. K., Chetty, A., Chumachenko, D., Consalves, G., Conway Morris, A., Cordie, A., Corrah, T., Crabtree-Ramirez, B., Dashdorj, N., Davidovitch, N., de Souza, L. E., Dhariwal, A. C., Druica, E., Ergonul, O., Erondu, N. A., Essar, M. Y., Ewing, A., Fanjul, G., Feierstein, D., Feigl-Ding, E., Figueroa, R., Figueroa, J. P., Fisher, D., Flores, W., Forero-Pena, D. A., Frumkin, H., Gamkrelidze, A., Gandhi, M., Garcia, P., Garcia-Basteiro, A. L., Garcia-Sastre, A., Garg, S., Gbeasor-Komlanvi, F. A., Gershenson, C., Gilada, I., Giovanella, L., Gonzalez, M., Green, M. S., Greenhalgh, T., Griffin, P., Griffin, S., Grinsztejn, B., Anand, T., Guerra, G., Guinto, R., Gujski, M., Guner, R., Hamdy, A., Hancean, M. -G., Haniffa, A., Hartigan-Go, K. Y., Hassan, H. K., Hay, S. I., Heino, M. T. J., Hel, Z., Hotez, P., Hu, J., Hukic, M., Ijsselmuiden, C., Iroko, D., Iskarous, M., Izugbara, C., Jacobs, C., Jadad, A. R., Jehan, F., Jordan, A., Jroundi, I., Kain, K., Kamberi, F., Karamov, E., Karan, A., Katz, R., Katzourakis, A., Kazembe, A., Khamis, F., Khamzayev, K., Khanyola, J., Khunti, K., Kiguli-Malwadde, E., Kim, W. J., Kirenga, B. J., Klimovsky, D., Kmush, B. L., Knaul, F., Kogevinas, M., Kristensen, F., Kumar, D., Kumar, R., Kvalsvig, A., Lacerda, M. V., Lal, A., Lawton, T., Lemery, J., Leonardi, A. J., Li, Y., Lottvall, J., Lounis, M., Maceira, D., Macintyre, C. R., Madani, A., Magiorkinis, G., Malekzadeh, R., Choisy, M., Marcelin, J. R., Marks, G. B., Marr, L., Marrazzo, J., Martina, A., Martin-Moreno, J. M., Mateos, C., Mayxay, M., Mazarati, J. B., Mboup, S., Mcdonald, J., Mcmillan, F., Mechili, E., Medici, A., Davis, S. L. M., Meier, P., Memish, Z. A., Menon, J., Menon, P., Mesiano-Crookston, J., Michie, S., Mikolasevic, I., Milicevic, O., Mishra, A. K., Mohamed, R., Mokdad, A. H., Monroy-Valle, M., Morawska, L., Moschos, S. A., Motawea, K., Mousavi, S. H., Mumtaz, G., Munene, P. K., Munoz Almagro, C., Muriuki, J., Muyingo, S., Naniche, D., Naylor, C. D., Ndembi, N., Nemec, J., Nesteruk, I., Ngaruiya, C., Nguyen, H., Nikolova, D., Nitzan, D., Norheim, O., Noushad, M., Ntoumi, F., Nyborg, G. A., Ochodo, E., Odabasi, Z., Okwen, M. P., Olivia, K., Ong, D. S. Y., Opara, I., Orozco, M., Oshitani, H., Pagel, C., Pai, M., Palsdottir, B., Papatheodoridis, G., Paraskevis, D., Leigh, J. P., Pecoul, B., Peichl, A., Perez-Then, E., Duc, P. P., Philippe, C., Pineda Rojas, A., Pladsen, C., Pozniak, A., Quiroga, R., Qureshi, H., Rampal, S., Ranney, M., Rathe, L., Ratzan, S., Raventos, H., Rees, H., Reis, R., Ricciardi, Walter, Rizk, N., Robalo, M., Robertson, E., Robinson, L., Rokx, C., Ros, T., Rottingen, J. -A., Rubin, M., Ruxrungtam, K., Sadirova, S., Saha, S., Salgado, N., Sanchez, L., Sangaramoorthy, T., Santamaria-Ulloa, C., Santos, R., Sawaf, B., Schneider, M. F., Schooley, R. T., Sener, A., Sepulveda, J., Shah, J., Shibani, M., Shoib, S., Sikazwe, I., Simaitis, A., Gill, A. S., Skhvitaridze, N., Sokolovic, M., Solomon, R., Solorzano, X., Springer, S. A., Srol, J., Staines, A., Stelfox, H. T., Strathdee, S., Sulaiman, L. H., Sutton, B., Svanaes, D., Swed, S., Sypsa, V., Sorensen, K., Tajudeen, R., Tan, A., Tang, J., Tanner, M., Sethi, T., Temmerman, M., Than, K. K., Tinto, H., Tometissi, S. P., Torres, I., Tshering, K. P., Tsiodras, S., Tsofa, B., Vahlne, A., Vargas, J. R., Bernal, I. D. V., Ventura, D., Vilasanjuan, R., Vipond, J., Wamala-Andersson, S., Wargocki, P., West, R., Weyand, A., White, T. M., Wolff, G., Yao, M., Yates, C. A., Yeboah, G., Yee-Sin, L., Yi, S., Teo, Y. -Y., Yong, P., Zamora-Mesia, V., Ovrehus, A., Cascini F. (ORCID:0000-0001-6499-0734), and Ricciardi W. (ORCID:0000-0002-5655-688X)

Abstract

Despite notable scientific and medical advances, broader political, socioeconomic and behavioural factors continue to undercut the response to the COVID-19 pandemic1,2. Here we convened, as part of this Delphi study, a diverse, multidisciplinary panel of 386 academic, health, non-governmental organization, government and other experts in COVID-19 response from 112 countries and territories to recommend specific actions to end this persistent global threat to public health. The panel developed a set of 41 consensus statements and 57 recommendations to governments, health systems, industry and other key stakeholders across six domains: communication; health systems; vaccination; prevention; treatment and care; and inequities. In the wake of nearly three years of fragmented global and national responses, it is instructive to note that three of the highest-ranked recommendations call for the adoption of whole-of-society and whole-of-government approaches1, while maintaining proven prevention measures using a vaccines-plus approach2 that employs a range of public health and financial support measures to complement vaccination. Other recommendations with at least 99% combined agreement advise governments and other stakeholders to improve communication, rebuild public trust and engage communities3 in the management of pandemic responses. The findings of the study, which have been further endorsed by 184 organizations globally, include points of unanimous agreement, as well as six recommendations with >5% disagreement, that provide health and social policy actions to address inadequacies in the pandemic response and help to bring this public health threat to an end.

Published
2022

4. Allocating external financing for health: a discrete choice experiment of stakeholder preferences

Author

Grepin, K.A., Pinkstaff, C.B., Hole, A.R., Henderson, K., Norheim, O.F., Rottingen, J.-A., and Ottersen, T.

Abstract

Most donors of external financing for health use allocation policies to determine which countries are eligible to receive financial support and how much support each should receive. Currently, most of these policies place a great deal of weight on income per capita as a determinant of aid allocation but there is increasing interest in putting more weight on other country characteristics in the design of such policies. It is unclear, however, how much weight should be placed on other country characteristics. Using an online discrete choice experiment designed to elicit preferences over country characteristics to guide decisions about the allocation of external financing for health, we find that stakeholders assign a great deal of importance to health inequalities and the burden of disease but put very little weight on income per capita. We also find considerable variation in preferences across stakeholders, with people from low- and middle-income countries putting more weight on the burden of disease and people from high-income countries putting more weight on health inequalities. These findings suggest that stakeholders put more weight on burden of disease and health inequalities than on income per capita in evaluating which countries should received external financing for health and that that people living in aid recipient may have different preferences than people living in donor countries. Donors may wish to take these differences in preferences in mind if they are reconsidering their aid allocation policies.

Published
2018

6. Exploring the evidence base for national and regional policy interventions to combat resistance

Author

Dar, F K, Littmann, J, Rweyemamu, M, Buckley, E J, Shahid, M, Kock, R A, Li, H L, Giha, H, Khan, M, So, A D, Bindayna, K M, Kessel, A, Pedersen, H B, Permanand, G, Zumla, A, Rottingen, J-A, and Heymann, D L

Abstract

The effectiveness of existing policies to control antimicrobial resistance is not yet fully understood. A strengthened evidence base is needed to inform effective policy interventions across countries with different income levels and the human health and animal sectors. We examine three policy domains—responsible use, surveillance, and infection prevention and control—and consider which will be the most effective at national and regional levels. Many complexities exist in the implementation of such policies across sectors and in varying political and regulatory environments. Therefore, we make recommendations for policy action, calling for comprehensive policy assessments, using standardised frameworks, of cost-effectiveness and generalisability. Such assessments are especially important in low-income and middle-income countries, and in the animal and environmental sectors. We also advocate a One Health approach that will enable the development of sensitive policies, accommodating the needs of each sector involved, and addressing concerns of specific countries and regions.

Published
2016

10. Coagulation factors VIIa and Xa induce cell signaling leading to up-regulation of the egr-1 gene.

Author

Camerer, E, Rottingen, J A, Gjernes, E, Larsen, K, Skartlien, A H, Iversen, J G, and Prydz, H

Abstract

Intracellular signaling induced by the coagulation factors (F) VIIa and Xa is poorly understood. We report here studies on these processes in a human keratinocyte line (HaCaT), which is a constitutive producer of tissue factor (TF) and responds to both FVIIa and FXa with elevation of cytosolic Ca(2+), phosphorylation of extracellular signal-regulated kinase (Erk) 1/2, p38(MAPK), and c-Jun N-terminal kinase, and up-regulation of transcription of the early growth response gene-1 (egr-1). Using egr-1 as end point, we observed with both agonists that phosphatidylinositol-specific phospholipase C and the mitogen-activated protein kinase/Erk kinase/Erk pathway were mediators of the responses. The responses to FVIIa were TF-dependent and up-regulation of egr-1 mRNA did not require presence of the TF cytoplasmic domain. Antibodies to EPR-1 and factor V had no effect on the response to FXa. We have provided evidence that TF is not the sole component of the FVIIa receptor. The requirement for proteolytic activity of both FVIIa and FXa suggests that protease-activated receptors may be involved. We now report evidence suggesting that protease-activated receptor 2 or a close homologue may be a necessary but not sufficient component of this particular signal transduction pathway. The up-regulation of egr-1 describes one way by which the initiation of blood coagulation may influence gene transcription. The ability of these coagulation proteases to induce intracellular signals at concentrations at or below the plasma concentrations of their zymogen precursors suggests that these processes may occur also in vivo.

Published
1999

11. Coagulation factors VII and X induce Ca2+ oscillations in Madin-Darby canine kidney cells only when proteolytically active.

Author

Camerer, E, Rottingen, J A, Iversen, J G, and Prydz, H

Abstract

We have recently reported that the activated serine protease and blood coagulation Factor VII (FVIIa) can induce Ca2+ oscillations in Madin-Darby canine kidney cells. We now demonstrate a similar response by Madin-Darby canine kidney cells to the active coagulation Factor X (FXa), which is also a serine protease and a substrate of the tissue factor (TF).FVIIa complex in the initiation of the coagulation cascade. The phosphatidyl inositol-specific phospholipase C inhibitor U73122 inhibited the signals elicited by both FVIIa and FXa. Lack of sensibility to the tyrosine kinase inhibitors herbimycin A, genistein, and the tyrphostin AG18 and discordance between TF expression and FVIIa responsiveness argued against TF acting as a cytokine-like receptor, with tyrosine kinase-mediated activation by FVIIa. As demonstrated using the protease inhibitor benzamidine and by specific active site inhibition with 1,5-dansyl-Glu-Gly-Arg chloromethyl ketone, both FVIIa and FXa lost their ability to elicit a calcium response when devoid of their proteolytic activity. Consistent with this, the native (zymogen) form of Factor X did not induce Ca2+ transients. Homologous but not heterologous inhibition of FVIIa- and FXa-evoked Ca2+ signals by 1,5-dansyl-Glu-Gly-Arg chloromethyl ketone-inactivated FVIIa and FXa suggested that each factor had its own specific cell surface anchoring receptor. The two coagulation factors did not show homologous desensitization as seen for thrombin stimulation. Studies with hirudin excluded involvement of the established activation pathway through thrombin itself. Lack of desensitization of the response to FVIIa or FXa by thrombin ruled out any involvement of proteinase activated receptor-1 (PAR-1), the thrombin receptor. We speculate that FXa and FVIIa may work via a receptor (possibly common) analogous to PAR-1 or its functional homologue PAR-2. Although TF is essential for the FVIIa-induced signaling event, its role in the phosphatidyl inositol-specific phospholipase C-mediated Ca2+ signal may be in anchoring FVIIa to the cell surface rather than in transmembrane signal mediation.

Published
1996

12. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results

Author

Carlos Guijarro, Farid Zand, Mohamed solyman Kabil, Sven Trelle, Birgitte Tholin, Belén Comeche, Johan Alexander Azañero Haro, Gonzalo Sierra Torres, Quarraisha Abdool Karim, Kari Tikkinen, Jean-michel Molina, Atousa Hakamifard, George M Varghese, Oscar Josue Ponce Ponte, Mazin Barry, Pilar Vizcarra, Niccolo Riccardi, Natalia Pérez-Macias, Aynaa AlSharidi, Nelson Lee, Alexandra Binnie, Firouzé BANI-SADR, Beatriz Díaz-Pollán, Aldo Pietro Maggioni, Ilkka Kalliala, Florian Desgranges, Anders Benjamin Kildal, Katerina Nezvalova-Henriksen, Corinne Merle, Andrés Martín Alcántara, Benjamin Gaborit, Daniel Lozano Martín, Antonio Ramos-Martinez, Miguel Villegas-Chiroque, Fredy Orlando Guevara Pulido, Ana Fernández-Cruz, Cormac McCarthy, Thesla Palanee-Phillips, Annalisa Marinosci, Abdullah Assiri, Florent Wallet, Juan Pablo Balbuena, Avik Ray, Francesc Puchades, Rajarao Mesipogu, Marjatta Sinisalo, Jonathan Sterne, Antonio Portolés, Heike Cappel-Porter, Jussi Mustonen, Jeremy Nel, BRUNO MOURVILLIER, María Consuelo Miranda Montoya, Chiara Fanciulli, L Marjukka Myllärniemi, Edinson Dante Meregildo Rodriguez, Alexy Inciarte, Mohamed Hassany, François Danion, Elena Muñez Rubio, Jean-Pierre QUENOT, Esperanza Merino de Lucas, Sheela Godbole, Luis Guillermo Barreto Rocchetti, Katerina Spasovska, William Connors, Kiana Shirani, Umang Agrawal, Srinivas Murthy, Bjorn Blomberg, Vasee Moorthy, Amith Balachandran, Antonio De Pablo Esteban, Mahnaz Amini, Dag Arne Lihaug Hoff, Zeinab Siami, Guillaume Martin-Blondel, Heng Gee Lee, Thrilok Chander Bingi, Vijay Krishnan, ANA BELEN RIVAS PATERNA, Eric D'Ortenzio, Samy Zaky, Carlos Arturo Alvarez-Moreno, Alonso Soto, VIKAS MARWAH, Marco Tulio Medina, Zaira R. Palacios-Baena, Jean-Sébastien Hulot, Miguel Angel Hueda Zavaleta, Felipe García, Francisco Fanjul, Hospices Civils de Lyon (HCL), INSERM UMR-S 606, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, PRES Sorbonne Paris-Cité, and Université Paris Denis Diderot, Université Paris Diderot - Paris 7 (UPD7), Michel-Avella, Amandine, Pan, H., Peto, R., Henao-Restrepo, A. -M., Preziosi, M. -P., Sathiyamoorthy, V., Karim, Q. A., Alejandria, M. M., Garcia, C. H., Kieny, M. -P., Malekzadeh, R., Murthy, S., Srinath Reddy, K., Periago, M. R., Hanna, P. A., Ader, F., Al-Bader, A. M., Alhasawi, A., Allum, E., Alotaibi, A., Alvarez-Moreno, C. A., Appadoo, S., Asiri, A., Aukrust, P., Barratt-Due, A., Bellani, S., Branca, M., Cappel-Porter, H. B. C., Cerrato, N., Chow, T. S., Como, N., Eustace, J., Garcia, P. J., Godbole, S., Gotuzzo, E., Griskevicius, L., Hamra, R., Hassan, M., Hassany, M., Hutton, D., Irmansyah, I., Jancoriene, L., Kirwan, J., Kumar, S., Lennon, P., Lopardo, G., Lydon, P., Magrini, N., Maguire, T., Manevska, S., Manuel, O., Mcginty, S., Medina, M. T., Mesa Rubio, M. L., Miranda-Montoya, M. C., Nel, J., Nunes, E. P., Perola, M., Portoles, A., Rasmin, M. R., Raza, A., Rees, H., Reges, P. P. S., Rogers, C. A., Salami, K., Salvadori, M. I., Sinani, N., Sterne, J. A. C., Stevanovikj, M., Tacconelli, E., Tikkinen, K. A. O., Trelle, S., Zaid, H., Rottingen, J. -A., Swaminathan S., &amp, Luzzati, R, Di Bella, S, Doctoral Programme in Population Health, Doctoral Programme in Biomedicine, HUS Abdominal Center, Department of Surgery, Urologian yksikkö, South Carelia Social and Health care District Eksote, HUS Heart and Lung Center, Department of Medicine, Clinicum, Department of Obstetrics and Gynecology, HUS Gynecology and Obstetrics, UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, and UCL - (SLuc) Service de médecine interne générale

Subjects
Male, Kaplan Meier method, Intention to Treat Analysi, MESH: Treatment Failure, MESH: Hydroxychloroquine, remdesivir, Rate ratio, MESH: Intention to Treat Analysis, MESH: Length of Stay, law.invention, Lopinavir/*therapeutic use, 0302 clinical medicine, middle aged, Medicine, Hospital Mortality, MESH: Respiration, Artificial, Antiviral Agents/administration & dosage/adverse effects/*therapeutic use, comparative study, beta1a interferon, MESH: Middle Aged, Alanine, Respiration, adult, clinical trial, General Medicine, 3. Good health, Intention to Treat Analysis, [SDV] Life Sciences [q-bio], aged, health care quality, priority journal, drug withdrawal, Artificial, Interferon, Drug Therapy, Combination, medicine.medical_specialty, Initiation of ventilation, Interferon beta-1a/*therapeutic use, World Health Organization, Antiviral Agents, Article, Duration of hospital stay, antiviral drugs, 03 medical and health sciences, Drug Therapy, death, Humans, MESH: Hospital Mortality, human, MESH: Kaplan-Meier Estimate, Aged, MESH: Humans, treatment duration, extracorporeal oxygenation, Hydroxychloroquine, Length of Stay, major clinical study, mortality, Respiration, Artificial, Adenosine Monophosphate/*analogs & derivatives/therapeutic use, multicenter study, Alanine/*analogs & derivatives/therapeutic use, MESH: Interferon beta-1a, randomized controlled trial, MESH: Female, antivirus agent, [SDV]Life Sciences [q-bio], MESH: Hospitalization, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Lopinavir, Adenosine Monophosphate, COVID-19, Female, Hospitalization, Interferon beta-1a, Middle Aged, Treatment Failure, Randomized controlled trial, Interquartile range, law, MESH: COVID-19, MESH: Adenosine Monophosphate, 030212 general & internal medicine, antiviral drugs, Covid-19, MESH: Aged, Hydroxychloroquine/*therapeutic use, MESH: Lopinavir, Covid19, artificial ventilation, drug therapy, ritonavir, hospital patient, female, Combination, medicine.drug, MESH: Antiviral Agents, combination drug therapy, COVID-19/*drug therapy/mortality, Randomization, MESH: Alanine, drug repositioning, drug clearance, adenosine phosphate, coronavirus disease 2019, length of stay, Internal medicine, controlled study, Antiviral Agent, Intention-to-treat analysis, business.industry, MESH: Male, COVID-19 Drug Treatment, purl.org/pe-repo/ocde/ford#3.02.00 [https], MESH: Drug Therapy, Combination, 3121 General medicine, internal medicine and other clinical medicine, business
Abstract

The authors report interim results of the WHO Solidarity trial of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with Covid-19. Effects on overall mortality, initiation of ventilation, and duration of hospital stay are compared. Background World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). Methods We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. Results At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. Conclusions These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ; ClinicalTrials.gov number, .)

Published
2020

13. Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations

Author

Ursula Theuretzbacher, Christine Årdal, Kevin Outterson, Francesco Ciabuschi, John-Arne Røttingen, Jens Plahte, Enrico Baraldi, Ardal C., Baraldi E., Theuretzbacher U., Outterson K., Plahte J., Ciabuschi F., and Rottingen J.-A.

Subjects
0301 basic medicine, DRIVE-AB, medicine.medical_specialty, lcsh:RS1-441, Pharmacy, Antimicrobial innovation, Business model, lcsh:Pharmacy and materia medica, 03 medical and health sciences, medicine, Marketing, Duration (project management), Business Administration, Företagsekonomi, business.industry, Health Policy, Public health, Research, lcsh:RM1-950, Stakeholder, Timeline, 030104 developmental biology, Incentive, lcsh:Therapeutics. Pharmacology, New product development, Antibacterial innovation, Business, Pharmaceutical research and development
Abstract

Background Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs’ targets, costs, and durations related to discovery and early phase development of antibacterial therapies. Methods DRIVE-AB, a project focused on developing new economic incentives to stimulate antibacterial innovation, held a European stakeholder meeting in February 2015. All SMEs invited to this meeting (n = 44) were subsequently sent a survey to gather more data regarding their areas of activity, completed and expected development costs and timelines, and business models. Results Twenty-five companies responded to the survey. Respondents were primarily small companies each focusing on developing 1 to 3 new antibiotics, focused on pathogens of public health importance. Most have not yet completed any clinical trials. They have reported ranges of discovery and development out-of-pocket costs that appear to be less expensive than other studies of general pharmaceutical research and development (R&D) costs. The duration ranges reported for completing each phase of R&D are highly variable when compared to previously published general pharmaceutical innovation average durations. However, our sample population is small and may not be fully representative of all relevant antibiotic SMEs. Conclusions The data collected by this study provide important insights and estimates about R&D in European SMEs focusing on antibiotics, which can be combined with other data to design incentives to stimulate antibacterial innovation. The variation implies that costs and durations are difficult to generalize due to the unique characteristics of each antibiotic project and depend on individual business strategies and circumstances.

Published
2018

14. Risk factors associated with typhoid fever in Son La province, northern Vietnam.

Author

Tran HH, Bjune G, Nguyen BM, Rottingen JA, Grais RF, and Guerin PJ

Subjects
Adolescent, Adult, Analysis of Variance, Case-Control Studies, Child, Female, Hospitalization statistics & numerical data, Humans, Logistic Models, Male, Risk Factors, Surveys and Questionnaires, Typhoid Fever prevention & control, Vietnam epidemiology, Typhoid Fever epidemiology
Abstract

Between July and December 2002, we undertook a hospital-based case-control study to identify risk factors associated with typhoid fever in Son La province, northern Vietnam. Among 617 suspected cases, 90 cases of typhoid fever were confirmed by blood or stool culture. One hundred and eighty controls (neighbours of typhoid cases matched for gender and age) were chosen. Participants were interviewed at home using a standardized questionnaire. Seventy-five per cent of cases were aged 10-44 years. No cases in patients aged less than 5 years were recorded in this study. In a conditional logistic regression analysis recent contact with a typhoid patient (OR = 3.3, 95% CI 1.7-6.2, P < 0.001), no education (OR = 2.0, 95% CI 1.0-3.7, P = 0.03) and drinking untreated water (OR = 3.9, 95% CI 2.0-7.5, P < 0.001) were independently associated with typhoid fever. Improving quality of drinking water must be a priority and health education strategies targeted at individuals with no schooling, and contacts of patients, would be expected to decrease the burden of typhoid fever.

Published
2005
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