Trial · NCT02821832
Using Biomarkers to Predict TB Treatment Duration
NCT02821832, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2022-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Using Biomarkers to Predict TB Treatment Duration. Trials, record NCT02821832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02821832
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Using Biomarkers to Predict TB Treatment Duration
- NCT number
- NCT02821832
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 946 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Pulmonary Tuberculosis
- Interventions
- Saliva collection, Urine collection, Sputum collection, Blood Collection, PET/CT Scan, Isoniazid, Rifampicin, Pyrazinamide and Ethambutol
- First posted
- 2016-07-04
- Last updated
- 2024-04-17
- Results first posted
- 2022-12-20
- Limitations and caveats
The COVID-19 pandemic forced the temporary halt of all study activities, which led to some missed visits. As study activities resumed, some study visits and PET/CT scans needed to be done out-of-window. All of the COVID-related protocol deviations can be attributed to clinical site restrictions and safety precautions taken to protect study staff and participants.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | 18 months | Estimation of the lower bound of a one-sided 95% confidence interval of the difference in success rates between arms B and C. If the lower bound is greater than -7%, this will be evidence that the treatment-shortening arm is not inferior to the standard duration arm. |
| Secondary | Radiologic, Immunologic and Microbiologic Measures | 18 months | The difference (and 95% confidence interval) in treatment success rates between a combined A+B Arm (with Arm A participants selected to represent a true 6-month standard of care population) and a combined Arm A+C (with the remaining Arm A participants selected to represent a treatment shortening strategy arm, and no overlap in Arm A participants assigned to B and C). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | 18 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Radiologic, Immunologic and Microbiologic Measures | 18 months |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm A | Cured | 217 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm B | Cured | 121 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm C | Cured | 117 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm A | Confirmed relapses | 5 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm B | Confirmed relapses | 1 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm C | Confirmed relapses | 9 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm A | Late withdrawal, lost to follow-up | 13 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm B | Late withdrawal, lost to follow-up | 9 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm C | Late withdrawal, lost to follow-up | 6 | Participants | |
| Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C | Arm A | Probable relapses | 1 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 251 | |
| Overall Study | STARTED | Arm B | 154 | |
| Overall Study | STARTED | Arm C | 141 | |
| Overall Study | COMPLETED | Arm A | 186 | |
| Overall Study | COMPLETED | Arm B | 106 | |
| Overall Study | COMPLETED | Arm C | 109 | |
| Overall Study | NOT COMPLETED | Arm A | 65 | |
| Overall Study | NOT COMPLETED | Arm B | 48 | |
| Overall Study | NOT COMPLETED | Arm C | 32 |
Source ClinicalTrials.gov
Adverse events93
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 |
|---|---|---|---|---|---|---|
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Arm A | 0 | 251 | 0 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Arm B | 0 | 154 | 0 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Arm C | 1 | 141 | 1 |
| serious | Alcoholic pancreatitis | Gastrointestinal disorders | Arm A | 1 | 251 | 1 |
| serious | Alcoholic pancreatitis | Gastrointestinal disorders | Arm B | 0 | 154 | 0 |
| serious | Alcoholic pancreatitis | Gastrointestinal disorders | Arm C | 0 | 141 | 0 |
| serious | Animal bite | Injury, poisoning and procedural complications | Arm A | 1 | 251 | 1 |
| serious | Animal bite | Injury, poisoning and procedural complications | Arm B | 0 | 154 | 0 |
| serious | Animal bite | Injury, poisoning and procedural complications | Arm C | 0 | 141 | 0 |
| serious | Appendicitis | Gastrointestinal disorders | Arm A | 1 | 251 | 1 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 4 | 251 |
| Total, all-cause mortality | Arm B | 3 | 154 |
| Total, all-cause mortality | Arm C | 0 | 141 |
| Total, other adverse events | Arm A | 0 | 251 |
| Total, other adverse events | Arm B | 0 | 154 |
| Total, other adverse events | Arm C | 0 | 141 |
| Total, serious adverse events | Arm A | 20 | 251 |
| Total, serious adverse events | Arm B | 5 | 154 |
| Total, serious adverse events | Arm C | 3 | 141 |
Source ClinicalTrials.gov
Papers4
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02821832
GET https://conductscience.org/api/trials/v1/NCT02821832/events?page=2