Skip to content

Advertisement

  • Poster presentation
  • Open Access

Short- versus long-term outcomes after treatment for tuberculosis

  • 1 and
  • 1
Trials201314 (Suppl 1) :P44

https://doi.org/10.1186/1745-6215-14-S1-P44

  • Published:

Keywords

  • Tuberculosis
  • Clinical Endpoint
  • Colony Count
  • Sputum Culture
  • Pivotal Trial

Background

TB remains a major killer amongst infectious diseases and current treatment involves a four-drug regimen for at least six months. Clinical development of a single novel TB drug is expected to take at least six years. A completely novel combination regimen would require twenty years or more. New drugs and regimens are required to shorten treatment duration, reduce toxicity and combat drug resistance.

We reviewed the ability of short-term outcomes from phase II trials to predict longer-term outcomes from phase III trials and hence improve selection of optimum combinations of new and existing drugs for development in pivotal trials.

Methods

Phase II or phase III trials of combinations of eight agents for drug sensitive individuals with tuberculosis were included in our systematic review. Definitive clinical endpoints included treatment failure and treatment relapse. Early clinical endpoints incorporated positive or negative culture at various time points, time to sputum culture conversion and serial viable colony counts.

For categorical data, the odds ratio will be calculated using the Mantel-Haenszel method, and for continuous data, such as colony counts, the mean difference will be calculated. Time to event outcomes will be summarised via the generic inverse-variance method. Additionally, early endpoints will be evaluated as surrogate outcomes for poor outcome via the generalised R2 statistic.

Results

2865 trials were identified for potential inclusion in the review. Of these, 47 phase II and 478 phase III trials were included. Data is currently being extracted and full results will be presented.

Authors’ Affiliations

(1)
University of Liverpool, Liverpool, UK

Copyright

© Bonnett and Davies; licensee BioMed Central Ltd. 2013

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Comments

By submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Please note that comments may be removed without notice if they are flagged by another user or do not comply with our community guidelines.

Advertisement