Evidence map›Paper›PMID 23667677›Full record

ArticlePloS one2013

An evaluation of culture results during treatment for tuberculosis as surrogate endpoints for treatment failure and relapse.

Patrick P J Phillips, Katherine Fielding, Andrew J Nunn

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 8 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Treatment Effect Measures for Culture Conversion Endpoints in Phase IIb Tuberculosis Treatment Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Comparing the Efficacy of Drug Regimens for Pulmonary Tuberculosis: Meta-analysis of Endpoints in Early-Phase Clinical Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
    Pooled it
  5. Guideline
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Optimising pyrazinamide for the treatment of tuberculosis.The European respiratory journal · 2021
    Trial
  11. Trial
  12. Trial
  13. High-Dose Vitamin DAmerican journal of respiratory and critical care medicine · 2017
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Article
  20. Beyond culturability: VBNC-like and differentially culturableFrontiers in cellular and infection microbiology · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Patrick P J PhillipsMedical Research Council Clinical Trials Unit, London, United Kingdom. patrick.phillips@ctu.mrc.ac.uk
Katherine Fielding
Andrew J Nunn

Funding

Medical Research Council MC_EX_G0800814Medical Research Council MC_U122888469Medical Research Council MR/K012126/1
6 · The paper itself

Abstract

It is widely acknowledged that new regimens are urgently needed for the treatment of tuberculosis. The primary endpoint in the Phase III trials is a composite outcome of failure at the end of treatment or relapse after stopping treatment. Such trials are usually both long and expensive. Valid surrogate endpoints measured during or at the end of treatment could dramatically reduce both the time and cost of assessing the effectiveness of new regimens. The objective of this study was to evaluate sputum culture results on solid media during treatment as surrogate endpoints for poor outcome. Data were obtained from twelve randomised controlled trials conducted by the British Medical Research Council in the 1970s and 80s in East Africa and East Asia, consisting of 6974 participants and 49 different treatment regimens. The month two culture result was shown to be a poor surrogate in East Africa but a good surrogate in Hong Kong. In contrast, the month three culture was a good surrogate in trials conducted in East Africa but not in Hong Kong. As well as differences in location, ethnicity and probable strain of Mycobacteria tuberculosis, Hong Kong trials more often evaluated regimens with rifampicin throughout and intermittent regimens, and patients in East African trials more often presented with extensive cavitation and were slower to convert to culture negative during treatment. An endpoint that is a summary measure of the longitudinal profile of culture results over time or that is able to detect the presence of M. tuberculosis later in treatment is more likely to be a better endpoint for a phase II trial than a culture result at a single time point and may prove to be an acceptable surrogate. More data are needed before any endpoint can be used as a surrogate in a confirmatory phase III trial.

Indexed as

BiomarkersCell Culture TechniquesClinical Trials, Phase III as TopicEndpoint DeterminationHumansLinear ModelsSputumTuberculosisBiomarkers

Identifiers

PMID23667677
PMCPMC3648512

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.