Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Lessons from a randomised clinical trial for multidrug-resistant tuberculosis
International Journal of Tuberculosis and Lung Disease, Volume 16, No. 12, Year 2012
Notification
URL copied to clipboard!
Description
BACKGROUND: The treatment of multidrug-resistant tuberculosis (MDR-TB) is currently based upon expert opinion and findings from case series, rather than upon randomised clinical trials (RCTs). OBJECTIVE: To describe the challenges encountered during an RCT for the treatment of MDR-TB. METHODS: Tuberculosis Trials Consortium Study 30 was a pilot, Phase I/II, double-blind, placebo-controlled, RCT of the safety and tolerability of 16 weeks of daily, low-dose linezolid treatment for MDR-TB. RESULTS: A total of 36 patients, 56% of the target of 64 patients, consented to participate, for an average of 0.69 enrolments per week. Of the 36 patients enrolled, only 25 (69%) completed at least 90 doses of study treatment. Among the 12 (33%) patients who did not complete all 112 doses of the study treatment, the median time to study withdrawal was 15 days (range 0-92). After the study, we discovered discordance between treatment assignment and study drug for at least 9 (25%) of the 36 patients. CONCLUSIONS: Recruitment and retention in this MDR-TB clinical trial posed substantial challenges, suggesting the need for a large, multidisciplinary group of study staff to support the participants. Withdrawal tended to occur early in study treatment. The discrepancy in assigned study medication reflects the need for stronger administrative controls for study drugs. © 2012 The Union.
Authors & Co-Authors
Padayatchi, Nesri
Unknown Affiliation
Mac Kenzie, William R.
Unknown Affiliation
Hirsch-Moverman, Yael R.
Unknown Affiliation
Feng, Pei Jean I.
Unknown Affiliation
Villarino, Elsa
Unknown Affiliation
Saukkonen, Jussi
Unknown Affiliation
Heilig, Charles M.
Unknown Affiliation
Weiner, Marc H.
Unknown Affiliation
El-Sadr, W. M.
Unknown Affiliation
Statistics
Citations: 12
Authors: 9
Affiliations: 6
Identifiers
Doi:
10.5588/ijtld.12.0315
ISSN:
10273719
Research Areas
Disability
Infectious Diseases
Study Design
Randomised Control Trial
Study Approach
Quantitative