Preliminary Registration Detail

Research Registry No : PLRID-00924_V1
Postgraduate Research : No
University Departmental Research : Yes
Name of University : Aung San TB Hospital
Department : National TB Program
Registration Date : 2020-08-19
Principle Investigator : Zaw Myint
Co-Investigators : Dr Si Thu Aung, Dr Anita Mesic, Helena Huerga, Mathieu Bastard, Elisa Ardizzoni, Francis Varaine, Ye Yint Naing
Title of Research : endTB (Expand New Drugs for TB) Observational Study: Treatment of MDR-TB with regimens containing bedaquiline or delamanid
Field of Research : Tropical and Infectious Diseases
Preliminary Research Design : Analytic Study
Preliminary Research Type : Applied
Preliminary Justification : -
Preliminary Aim : endTB aims to find shorter, less toxic and more effective treatments for ‘multidrug-resistant TB’
Preliminary Objectives : Primary objectives: 1. To describe patient outcomes and assess factors associated with unfavorable outcomes (treatment failure, lost to follow-up and death). 2. To estimate the frequency of adverse events of clinical significance. Secondary objectives: 3. To assess the frequency of relapse 6 months after successful treatment completion. 4. To describe the frequency and timing of smear and culture conversion. 5. To describe the frequency of resistance acquisition to fluoroquinolones, second-line injectables and in a subgroup of patients, to bedaquiline, delamanid, linezolid and clofazimine. 6. To describe the distribution of: indications for use of bedaquiline and delamanid; treatment regimens used; frequency and reasons for drug interruptions, drug discontinuations, dose adjustments and regimen changes. 7. To assess delay time between being declared eligible for bedaquiline or delamanid and treatment start.
Preliminary Sample Size : 50/All MDR-TB patients started on treatment containing bedaquiline or delamanid and enrolled in clinical care within the endTB Project and the Myanmar National Tuberculosis Program.
Preliminary Study Duration : 5 years (ERB approval in Myanmar will be extended yearly as per country regulations)
Preliminary Study Area : Yangon/NTP/Aung San TB Hospital
Preliminary Study Method : Prospective and retrospective observational cohort
Preliminary Research Outcome : ongoing process
Preliminary Research Finding : ongoing process
Preliminary Progress Report : In total 50 patients have been included in Myanmar from May 2016 up to the end of April 2018. Informed consent was obtained from all the patients. The median age of enrolled patients was 36.4 years with interquartile range of 26.9-45.7. The majority of th
Study Starting Date : 2020-12-01
IRB/PRC/ERC Approval Date : 2027-06-15
IRB/PRC/ERC Approval Letter/Document : 14102020033304IRBExtensionApproval2020Scanneddocument.pdf
Pre-existing Registration ID : -
Pre-existing Name of Organization : -
Pre-existing Name of Organization Website : -