Evidence map›Paper›PMID 19542476›Full record

Trial reportAmerican journal of respiratory and critical care medicine2009

Shortening treatment in adults with noncavitary tuberculosis and 2-month culture conversion.

John L Johnson, David Jamil Hadad, Reynaldo Dietze, Ethel Leonor Noia Maciel, Barrett Sewali, Phineas Gitta, Alphonse Okwera, Roy D Mugerwa, Mary Rose Alcaneses, Maria Imelda Quelapio and 5 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 77 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 5 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.

NCT00130247 phase3completednot on this map

A Prospective Study of Shortening the Duration of Standard Short Course Chemotherapy From 6 Months to 4 Months in HIV-non-infected Patients With Fully Drug-Susceptible, Non-cavitary Pulmonary Tuberculosis With Negative Sputum Cultures After 2 Months of Anti-TB Treatment

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2002 to 2008Enrolled394ConditionsTuberculosisArmsEthambutol, Isoniazid, Pyrazinamide, Rifampin
NCT04930744 phase2completednot on this mapstarted 2022, after this paper: background citation

A Prospective, Randomized Open-Label Phase II Study of the Safety and Tolerability of Metformin in Combination With Standard Antimicrobial Treatment of Pulmonary Tuberculosis in People Co-infected With HIV

TypeinterventionalSponsorUniversity of Massachusetts, WorcesterRan2022 to 2025Enrolled112ConditionsTuberculosis, Pulmonary Tuberculosis, HIV CoinfectionArmsIsoniazid, Rifampicin, Ethambutol, Pyrazinamide, Metformin hydrochoride
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Treatment Strategy for Rifampin-Susceptible Tuberculosis.The New England journal of medicine · 2023
    Trial
  8. Trial
  9. Trial
  10. Efficacy and Safety of High-Dose Rifampin in Pulmonary Tuberculosis. A Randomized Controlled Trial.American journal of respiratory and critical care medicine · 2018
    Trial
  11. Trial
  12. Tackling the unknowns of short-course rifapentine-based treatment for active tuberculosis: a decision analysis.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2016
    Trial
  13. Trial
  14. Smoking and 2-month culture conversion during anti-tuberculosis treatment.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2013
    Trial
  15. Trial
  16. Article
  17. Clinical Implications of Time to Culture Conversion inOpen forum infectious diseases · 2025
    Article
  18. Review
  19. GEODE: anFrontiers in pharmacology · 2025
    Article
  20. Article

17 more citing papers are in PubMed but not listed here.

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

15 authors.

John L JohnsonTuberculosis Research Unit, Department of Medicine, Case Western Reserve University School of Medicine and University Hospitals Case Medical Center, Cleveland, Ohio 44106-5083, USA. jlj@case.edu
David Jamil Hadad
Reynaldo Dietze
Ethel Leonor Noia Maciel
Barrett Sewali
Phineas Gitta
Alphonse Okwera
Roy D Mugerwa
Mary Rose Alcaneses
Maria Imelda Quelapio
Thelma E Tupasi
Libby Horter
Sara M Debanne
Kathleen D Eisenach
W Henry Boom

Funding

Tuberculosis Prevention Research Unit /TBRU/-266095383N01AI095383 · NIAID · CASE WESTERN RESERVE UNIVERSITY · 2000 to 2005
$5.6M
NIAID NIH HHS N01-AI-70022NIAID NIH HHS N01-AI95383PHS HHS HHSN266200700022C
6 · The paper itself

Abstract

rationaleCavitary disease and delayed culture conversion have been associated with relapse. Combining patient characteristics and measures of bacteriologic response might allow treatment shortening with current drugs in some patients.

objectivesTo assess whether treatment could be shortened from 6 to 4 months in patients with noncavitary tuberculosis whose sputum cultures converted to negative after 2 months.

methodsThis study was a randomized, open-label equivalence trial. HIV-uninfected adults with noncavitary tuberculosis were treated daily with isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months, followed by 2 months of isoniazid and rifampin. After 4 months, patients with drug-susceptible TB whose sputum cultures on solid media were negative after 8 weeks of treatment were randomly assigned to continue treatment for 2 more months or to stop treatment. Patients were followed for relapse for 30 months after beginning treatment. MEASUREMENTS AND MAIN

resultsEnrollment was stopped by the safety monitoring committee after 394 patients were enrolled due to apparent increased risk for relapse in the 4-month arm. A total of 370 patients were eligible for per protocol analysis. Thirteen patients in the 4-month arm relapsed, compared with three subjects in the 6-month arm (7.0 vs. 1.6%; risk difference, 0.054; 95% confidence interval with Hauck-Anderson correction, 0.01-0.10).

conclusionShortening treatment from 6 to 4 months in adults with noncavitary disease and culture conversion after 2 months using current drugs resulted in a greater relapse rate. The combination of noncavitary disease and 2-month culture conversion was insufficient to identify patients with decreased risk for relapse.

Indexed as

AdultAntitubercular AgentsDrug Administration ScheduleDrug Therapy, CombinationEthambutolFemaleHumansIsoniazidKaplan-Meier EstimateMaleMycobacterium tuberculosisProportional Hazards ModelsPyrazinamideRifampinSputumTreatment OutcomeAntitubercular AgentsEthambutolIsoniazidPyrazinamideRifampin

Identifiers

PMID19542476
PMCPMC2742745

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.