Research Protocol - Effectiveness of a simplified short regimen for Multidrug Resistant Tuberculosis treatment in Karakalpakstan, Uzbekistan

Hdl Handle:
http://hdl.handle.net/10144/322296
Title:
Research Protocol - Effectiveness of a simplified short regimen for Multidrug Resistant Tuberculosis treatment in Karakalpakstan, Uzbekistan
Authors:
du Cros, Philipp; Atadjan, Khamraev; Mirzagalib, Tillashaikhov; Nargiza, Parpieva; Zinaida, Tigay; Marjan, Sholtaeva; Tleubergen, Abdrasuliev; Betlam, Marttje; Wise, Emily; Ashagre, Teshome; Kuhlin, Johanna; Slyzkyi, Andrii; Taye, Alia; Dietrich, Sebastian; Nyangwa, Bern-Thomas; Greig, Jane; Hepple, Pamela; Cooke, Graham; Herboczek, Krzysztof; Asif, Muhammad; Achar, Jay; Berry, Catherine
Abstract:
Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated with high default rates, and experience in the MSF programme in Uzbekistan shows that the current standard treatment greatly limits the ability to scale up to meet the high rates of MDR TB in the region. A prospective observational study has been designed. The primary outcome measure is the success rate at the end of treatment, and relapse and re-infection rates during 12 months of follow up after completion of treatment. Secondary outcome measures include rate of adverse events, interim outcomes with sputum smear microscopy and culture conversion rates at 4 and 6 months and time to conversion. Primary objective: To describe outcomes at end of treatment and relapse rate at 1 year following treatment completion of a short course (9-11 month) MDR TB treatment in programmatic conditions in Karakalpakstan, Uzbekistan. Secondary objectives: 1. To describe the adverse events of the treatment regimen 2. To evaluate risk factors for unfavorable outcomes (death, lost-to-follow up and failure) and relapse as a combined cohort. 3. To describe the rate of resistance amplification amongst patients with outcome failure.
Affiliation:
Médecins Sans Frontières, Operational Center Amsterdam; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Imperial College London; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam
Issue Date:
Jul-2014
URI:
http://hdl.handle.net/10144/322296
Type:
Other
Language:
en
Description:
Research protocol. These materials can be used, adapted and copied as long as citation of the source is given including the direct URL to the material. This work is licensed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0/ https://i.creativecommons.org/l/by/4.0/88x31.png
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DC FieldValue Language
dc.contributor.authordu Cros, Philipp; Atadjan, Khamraev; Mirzagalib, Tillashaikhov; Nargiza, Parpieva; Zinaida, Tigay; Marjan, Sholtaeva; Tleubergen, Abdrasuliev; Betlam, Marttje; Wise, Emily; Ashagre, Teshome; Kuhlin, Johanna; Slyzkyi, Andrii; Taye, Alia; Dietrich, Sebastian; Nyangwa, Bern-Thomas; Greig, Jane; Hepple, Pamela; Cooke, Graham; Herboczek, Krzysztof; Asif, Muhammad; Achar, Jay; Berry, Catherineen_GB
dc.date.accessioned2014-07-01T11:04:05Z-
dc.date.available2014-07-01T11:04:05Z-
dc.date.issued2014-07-
dc.identifier.urihttp://hdl.handle.net/10144/322296-
dc.descriptionResearch protocol. These materials can be used, adapted and copied as long as citation of the source is given including the direct URL to the material. This work is licensed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0/ https://i.creativecommons.org/l/by/4.0/88x31.pngen_GB
dc.description.abstractMultidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated with high default rates, and experience in the MSF programme in Uzbekistan shows that the current standard treatment greatly limits the ability to scale up to meet the high rates of MDR TB in the region. A prospective observational study has been designed. The primary outcome measure is the success rate at the end of treatment, and relapse and re-infection rates during 12 months of follow up after completion of treatment. Secondary outcome measures include rate of adverse events, interim outcomes with sputum smear microscopy and culture conversion rates at 4 and 6 months and time to conversion. Primary objective: To describe outcomes at end of treatment and relapse rate at 1 year following treatment completion of a short course (9-11 month) MDR TB treatment in programmatic conditions in Karakalpakstan, Uzbekistan. Secondary objectives: 1. To describe the adverse events of the treatment regimen 2. To evaluate risk factors for unfavorable outcomes (death, lost-to-follow up and failure) and relapse as a combined cohort. 3. To describe the rate of resistance amplification amongst patients with outcome failure.en_GB
dc.language.isoenen
dc.subjectMDR TBen_GB
dc.subjecttreatmenten_GB
dc.titleResearch Protocol - Effectiveness of a simplified short regimen for Multidrug Resistant Tuberculosis treatment in Karakalpakstan, Uzbekistanen
dc.typeOtheren
dc.contributor.departmentMédecins Sans Frontières, Operational Center Amsterdam; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Ministry of Health Uzbekistan; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Imperial College London; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdam; Médecins Sans Frontières, Operational Center Amsterdamen_GB
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