Trial · NCT00023452
Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection
NCT00023452, Phase 3, Completed, Centers for Disease Control and Prevention; results first posted 2012-09-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection. Trials, record NCT00023452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00023452
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection
- NCT number
- NCT00023452
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 8,053 participants, actual
- Lead sponsor
- Centers for Disease Control and Prevention
- Conditions
- Tuberculosis
- Interventions
- RPT + INH once weekly for 3 months given by DOT, Isoniazid (INH) daily for 9 months
- First posted
- 2001-09-10
- Last updated
- 2024-08-27
- Results first posted
- 2012-09-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment | Baseline up to Month 33 | Cumulative TB disease rate defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for Mycobacterium tuberculosis \[MTB\]) and those \<18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease \[cough, fever, night sweats, weight loss, or hemoptysis\] based on history or physical exam plus radiograph, computed tomography \[CT\] scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for acid-fast bacilli \[AFB\], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants with (w/)33 months of follow-up calculated using survival analysis methods (Kaplan-Meier approach). |
| Secondary | Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy | Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH) | Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and those \<18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease \[cough, fever, night sweats, weight loss, or hemoptysis\] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB\], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach). |
| Secondary | Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment | Baseline up to 33 Months | Cumulative TB disease rate was defined as number of participants (regardless of age) with culture-confirmed TB disease (defined as positive culture for MTB\]) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease \[cough, fever, night sweats, weight loss, or hemoptysis\] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB, or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach). |
| Secondary | Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH | Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH]) | Discontinuation of study drug due to an adverse drug reaction associated with either 3RPT/INH or 9INH was defined as discontinuing treatment and/or study due to a treatment-related adverse event (AE) (considered either possibly, probably, or definitely related to the study drug by the investigator). |
| Secondary | Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH | Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH]) | Drug toxicities (or AEs) were graded using Common Toxicity Criteria (CTC version 2.0, Publish Date April 30, 1999, Cancer Therapy Evaluation Program). Grade 3 and 4 drug toxicities associated with 3RPT/INH or 9INH were defined as treatment-related Grade 3 or 4 AEs (considered either possibly, probably, or definitely related to the study drug by the investigator). |
| Secondary | Percentage of Participants With Death Due to Any Cause | Baseline up to Month 35 | |
| Secondary | Percentage of Participants With Methadone Withdrawal Associated With 3RPT/INH and 9INH Among Participants Receiving Concomitant Methadone | Baseline to Month 33 | Among participants concomitantly receiving methadone, the development of methadone withdrawal (defined as having \>3 new symptoms for \>7 days: nausea and vomiting, abdominal cramps, body aches, restlessness, irritability, dilated pupils, tremors, involuntary twitching, lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose flesh, or diarrhea). |
| Secondary | Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH | Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH) | Drug discontinuations for any reason associated with 3RPT/INH or 9INH included all reasons for discontinuation from study treatment, regardless of relationship to treatment. |
| Secondary | Percentage of Participants Who Completed the Treatment Regimen | Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH) | Completion in the 3RPT/INH arm was defined as: received 12 doses of RPT/INH within 16 weeks (12 weeks optimal). However, participants were considered to have completed therapy if at least 11 doses of RPT/INH had been received (\~90%) during the 16-week time period. Completion in the 9INH arm was defined as: received 270 doses of INH within 52 weeks (39 weeks optimal). However, participants were considered to have completed therapy if at least 240 doses of INH were received (\~90%) during the 52-week period. |
| Secondary | Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment | Baseline up to Month 33 | Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and \<18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease \[cough, fever, night sweats, weight loss, or hemoptysis\] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB\], or caseating granulomata at autopsy or biopsy) between enrollment and 33 months after enrollment (for those who completed therapy within 33 months) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment | Baseline up to Month 33 | Modified Intention-to-Treat (MITT) Population: all participants who enrolled in study and were eligible (Ineligible=source TB case resistant to INH or rifampin; source TB case culture-negative for MTB; positive TST not confirmed; MTB drug susceptibility test results not available for source TB case; or TB disease at enrollment). | TB cases per 100 participants w/followup | NUMBER |
| SECONDARY | Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy | Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH) | MITT Population | TB cases per 100 participants w/followup | NUMBER |
| SECONDARY | Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment | Baseline up to 33 Months | TB cases per 100 participants w/followup | NUMBER | |
| SECONDARY | Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH | Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH]) | Safety Population: all participants who enrolled in the study and took at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH | Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH]) | Safety Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Death Due to Any Cause | Baseline up to Month 35 | Safety Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Methadone Withdrawal Associated With 3RPT/INH and 9INH Among Participants Receiving Concomitant Methadone | Baseline to Month 33 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH | Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH) | MITT Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Completed the Treatment Regimen | Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH) | MITT Population | percentage of participants | NUMBER |
| SECONDARY | Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment | Baseline up to Month 33 | Per Protocol Population: all enrolled and eligible participants (MITT Population) who completed study drug within targeted time period (11-12 3RPT/INH doses within 10-16 weeks; 240-270 INH doses within 35-52 weeks) or developed TB disease or died while on study therapy (or follow-up) but completed ≥75% of expected number of doses prior to event. | TB cases per 100 participants w/followup | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment | 9INH | 0.43 | TB cases per 100 participants w/followup | ||
Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment | 3RPT/INH | 0.19 | TB cases per 100 participants w/followup | ||
Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy | 9INH | 0.37 | TB cases per 100 participants w/followup | ||
Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy | 3RPT/INH | 0.16 | TB cases per 100 participants w/followup | ||
| Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment | 9INH | 0.49 | TB cases per 100 participants w/followup | ||
| Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment | 3RPT/INH | 0.24 | TB cases per 100 participants w/followup | ||
| Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH | 9INH | 3.8 | percentage of participants | ||
| Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH | 3RPT/INH | 4.9 | percentage of participants | ||
| Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH | 9INH | Grade 3 | 2.2 | percentage of participants | |
| Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH | 3RPT/INH | Grade 3 | 2.7 | percentage of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 9INH | 3,908 | |
| Overall Study | STARTED | 3RPT/INH | 4,145 | |
| Overall Study | Randomized | 9INH | 3,190 | |
| Overall Study | Randomized | 3RPT/INH | 3,174 | |
| Overall Study | Enrolled as Part of a Cluster | 9INH | 718 | |
| Overall Study | Enrolled as Part of a Cluster | 3RPT/INH | 971 | |
| Overall Study | Completed Treatment | 9INH | 2,585 | |
| Overall Study | Completed Treatment | 3RPT/INH | 3,273 | |
| Overall Study | Not Treated | 9INH | 149 | |
| Overall Study | Not Treated | 3RPT/INH | 105 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events260
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 | Hypersensitivity | Immune system disorders | 9INH | 17 | 3,759 | |
| other | Hypersensitivity | Immune system disorders | 3RPT/INH | 153 | 4,040 | |
| other | Medication error | Injury, poisoning and procedural complications | 9INH | 36 | 3,759 | |
| other | Medication error | Injury, poisoning and procedural complications | 3RPT/INH | 27 | 4,040 | |
| other | Hepatitis | Hepatobiliary disorders | 9INH | 110 | 3,759 | |
| other | Hepatitis | Hepatobiliary disorders | 3RPT/INH | 24 | 4,040 | |
| other | Pregnancy | Pregnancy, puerperium and perinatal conditions | 9INH | 69 | 3,759 | |
| other | Pregnancy | Pregnancy, puerperium and perinatal conditions | 3RPT/INH | 45 | 4,040 | |
| serious | Hernia repair | Surgical and medical procedures | 9INH | 3 | 3,759 | |
| serious | Hernia repair | Surgical and medical procedures | 3RPT/INH | 0 | 4,040 |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 9INH | ||
| Total, all-cause mortality | 3RPT/INH | ||
| Total, other adverse events | 9INH | 226 | 3,759 |
| Total, other adverse events | 3RPT/INH | 248 | 4,040 |
| Total, serious adverse events | 9INH | 102 | 3,759 |
| Total, serious adverse events | 3RPT/INH | 60 | 4,040 |
Source ClinicalTrials.gov
Papers9
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 9INH vs 3RPT/INH: Percentage of Participants With Methadone Withdrawal Associated With 3RPT/INH and 9INH Among Participants Receiving Concomitant Methadone | Trial comparisons |
| 9INH vs 3RPT/INH: 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/NCT00023452
GET https://conductscience.org/api/trials/v1/NCT00023452/results?page=2