Trial · NCT00130247
Tuberculosis Treatment Shortening Trial
NCT00130247, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2010-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tuberculosis Treatment Shortening Trial. Trials, record NCT00130247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00130247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tuberculosis Treatment Shortening Trial
- NCT number
- NCT00130247
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 394 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Tuberculosis
- Interventions
- Ethambutol, Isoniazid, Pyrazinamide, Rifampin
- First posted
- 2005-08-15
- Last updated
- 2026-10-15
- Results first posted
- 2010-01-27
- Limitations and caveats
- Enrollment was stopped early and the number of patients enrolled was 1/2 of the original sample size. The study was completed.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat | 30 months | Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive \[defined as at least 1 of the following\]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment. |
| Primary | Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-TB Treatment - Per-protocol | 30 months | Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive \[defined as at least 1 of the following\]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment. |
| Secondary | Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat | 2 years | A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence. |
| Secondary | Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol | 2 years | A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence. |
| Secondary | Relapses at 1 and 2 Years | 1 and 2 years after successful completion of initial anti-TB treatment | |
| Secondary | Acquired Drug Resistance in Patients Who Relapsed | 2 years | |
| Secondary | Immunologic: Changes in Cytokine Levels in Mycobacterium Tuberculosis (MTB) Antigen-stimulated Whole Blood Culture Supernatants | After 2 and 6 months of anti-TB treatment and upon relapse | |
| Secondary | Immunologic: Store Peripheral Blood Mononuclear Cells (PBMC) | Pre-treatment and serum pre-treatment after 2 and 6 months of anti-TB treatment, and at the time of relapse for future immunologic analysis | |
| Secondary | Immunologic: Changes in Sputum Cytokine Levels | After 1 and 2 months of anti-TB treatment | |
| Secondary | Microbiologic: Changes in Sputum Mycobacterial mRNA | At 1 and 2 months of anti-TB treatment, and upon relapse |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat | 30 months | The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset. | Participants | NUMBER |
| SECONDARY | Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat | 2 years | The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset. | Participants | NUMBER |
| SECONDARY | Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol | 2 years | The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention. | Participants | NUMBER |
| SECONDARY | Relapses at 1 and 2 Years | 1 and 2 years after successful completion of initial anti-TB treatment | Analysis includes the 386 patients who received the intervention, completed treatment, and started post-treatment follow-up (193 patients in each treatment arm). Two subjects were lost after completing treatment and contributed no follow-up time, and 6 subjects did not receive the intervention so were not included in the analysis. | Participants | NUMBER |
| SECONDARY | Acquired Drug Resistance in Patients Who Relapsed | 2 years | This analysis was per protocol and looked for acquired drug resistance among the 13 patients in the 4-Month Arm who relapsed and the 3 patients in the 6-Month Arm who relapsed. | Participants | NUMBER |
| SECONDARY | Immunologic: Changes in Cytokine Levels in Mycobacterium Tubercolosis (MTB) Antigen-stimulated Whole Blood Culture Supernatants - Results Are Pending | After 2 and 6 months of anti-TB treatment and upon relapse | |||
| SECONDARY | Immunologic: Store Peripheral Blood Mononuclear Cells (PBMC) - Results Are Pending | Pre-treatment and serum pre-treatment after 2 and 6 months of anti-TB treatment, and at the time of relapse for future immunologic analysis | |||
| SECONDARY | Immunologic: Changes in Sputum Cytokine Levels - Results Are Pending | After 1 and 2 months of anti-TB treatment | |||
| SECONDARY | Microbiologic: Changes in Sputum Mycobacterial mRNA - Results Are Pending | At 1 and 2 months of anti-TB treatment, and upon relapse | |||
| PRIMARY | Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-TB Treatment - Per-protocol | 30 months | The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention. | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat | 4-Month Arm | 13 | Participants | ||
| Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat | 6-Month Arm | 3 | Participants | ||
| Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat | 4-Month Arm | Treatment Failures | 0 | Participants | |
| Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat | 6-Month Arm | Treatment Failures | 0 | Participants | |
| Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat | 4-Month Arm | Relapses | 13 | Participants | |
| Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat | 6-Month Arm | Relapses | 3 | Participants | |
| Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol | 4-Month Arm | Treatment Failures | 0 | Participants | |
| Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol | 6-Month Arm | Treatment Failures | 0 | Participants | |
| Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol | 4-Month Arm | Relapses | 13 | Participants | |
| Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol | 6-Month Arm | Relapses | 3 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 4-Month Arm | 196 | |
| Overall Study | STARTED | 6-Month Arm | 198 | |
| Overall Study | COMPLETED | 4-Month Arm | 194 | |
| Overall Study | COMPLETED | 6-Month Arm | 194 | |
| Overall Study | NOT COMPLETED | 4-Month Arm | 2 | |
| Overall Study | NOT COMPLETED | 6-Month Arm | 4 |
Source ClinicalTrials.gov
Adverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | 4-Month Arm | 48 | 196 | 63 |
| other | Abdominal Pain | Gastrointestinal disorders | 6-Month Arm | 49 | 198 | 59 |
| other | Acne | Skin and subcutaneous tissue disorders | 4-Month Arm | 14 | 196 | 15 |
| other | Acne | Skin and subcutaneous tissue disorders | 6-Month Arm | 16 | 198 | 17 |
| other | Appetite Lost | Metabolism and nutrition disorders | 4-Month Arm | 39 | 196 | 49 |
| other | Appetite Lost | Metabolism and nutrition disorders | 6-Month Arm | 30 | 198 | 35 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 4-Month Arm | 64 | 196 | 92 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | 6-Month Arm | 64 | 198 | 87 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 4-Month Arm | 34 | 196 | 46 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 6-Month Arm | 31 | 198 | 36 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 4-Month Arm | ||
| Total, all-cause mortality | 6-Month Arm | ||
| Total, other adverse events | 4-Month Arm | 170 | 196 |
| Total, other adverse events | 6-Month Arm | 164 | 198 |
| Total, serious adverse events | 4-Month Arm | 19 | 196 |
| Total, serious adverse events | 6-Month Arm | 22 | 198 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 4-Month Arm vs 6-Month Arm: Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat | Trial comparisons |
| 4-Month Arm vs 6-Month Arm: Acquired Drug Resistance in Patients Who Relapsed | Trial comparisons |
| 4-Month Arm vs 6-Month Arm: Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-TB Treatment - Per-protocol | Trial comparisons |
| 4-Month Arm vs 6-Month Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00130247
GET https://conductscience.org/api/trials/v1/NCT00130247/events?page=2