Trial · NCT01408914

Trial of High-Dose Rifampin in Patients With TB

NCT01408914, Phase 2, Completed, Harvard University Faculty of Medicine; results first posted 2017-07-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of High-Dose Rifampin in Patients With TB. Trials, record NCT01408914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01408914

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of High-Dose Rifampin in Patients With TB
NCT number: NCT01408914
Status: Completed
Phases: Phase 2
Enrollment: 180 participants, actual
Lead sponsor: Harvard University Faculty of Medicine
Conditions: Tuberculosis
Interventions: Higher-Dose Rifampin
First posted: 2011-08-03
Last updated: 2017-11-20
Results first posted: 2017-07-13

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Steady State Pharmacokinetic Exposure of RIF	At any time during the intensive phase of treatment, after steady state has been reached (at a minimum, after 14 days of daily RIF delivery)	The endpoint is the (dimensionless) ratio of AUC0-6 mcg/ml\*h to MIC99.9 mcg/ml
Secondary	Sputum Culture Sterilization During the Initial 8 Weeks of Treatment	Until 8 weeks of treatment are completed	Number of participants that are sputum culture (in LJ) negative for TB at 8 weeks
Secondary	Incidence of Rifampin-related Grade 2 or Higher Adverse Events	Throughout the 12 weeks post treatment initiation	Number of participants experiencing at least one rifampin-related grade 2 or higher adverse events during the initial 8 weeks of treatment and up to four weeks after.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Steady State Pharmacokinetic Exposure of RIF	At any time during the intensive phase of treatment, after steady state has been reached (at a minimum, after 14 days of daily RIF delivery)	Analysis was completed in 168 participants evaluable for pharmacokinetics, as samples were unable to be collected in 12 study participants.	Ratio	MEDIAN
SECONDARY	Sputum Culture Sterilization During the Initial 8 Weeks of Treatment	Until 8 weeks of treatment are completed		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Rifampin-related Grade 2 or Higher Adverse Events	Throughout the 12 weeks post treatment initiation		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Steady State Pharmacokinetic Exposure of RIF	10 mg/kg	115.6988	Inter-Quartile Range 59.1233 to 197.5544	Ratio
Steady State Pharmacokinetic Exposure of RIF	15 mg/kg	201.9725	Inter-Quartile Range 144.1413 to 460.2869	Ratio
Steady State Pharmacokinetic Exposure of RIF	20 mg/kg	284.4278	Inter-Quartile Range 175.2923 to 399.2127	Ratio
Sputum Culture Sterilization During the Initial 8 Weeks of Treatment	10 mg/kg	46		Participants
Sputum Culture Sterilization During the Initial 8 Weeks of Treatment	15 mg/kg	44		Participants
Sputum Culture Sterilization During the Initial 8 Weeks of Treatment	20 mg/kg	45		Participants
Incidence of Rifampin-related Grade 2 or Higher Adverse Events	10 mg/kg	26		Participants
Incidence of Rifampin-related Grade 2 or Higher Adverse Events	15 mg/kg	31		Participants
Incidence of Rifampin-related Grade 2 or Higher Adverse Events	20 mg/kg	23		Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	10 mg/kg	60
Overall Study	STARTED	15 mg/kg	60
Overall Study	STARTED	20 mg/kg	60
Overall Study	COMPLETED	10 mg/kg	48
Overall Study	COMPLETED	15 mg/kg	48
Overall Study	COMPLETED	20 mg/kg	47
Overall Study	NOT COMPLETED	10 mg/kg	12
Overall Study	NOT COMPLETED	15 mg/kg	12
Overall Study	NOT COMPLETED	20 mg/kg	13

Source ClinicalTrials.gov

Adverse events42

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	Blood and lymphatic system disorders	Blood and lymphatic system disorders	10 mg/kg	1	60	1
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	15 mg/kg	1	60	1
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	20 mg/kg	1	60	1
other	Gastrointestinal disorders	Gastrointestinal disorders	10 mg/kg	4	60	4
other	Gastrointestinal disorders	Gastrointestinal disorders	15 mg/kg	13	60	15
other	Gastrointestinal disorders	Gastrointestinal disorders	20 mg/kg	4	60	5
other	Hepatobiliary disorders	Hepatobiliary disorders	10 mg/kg	16	60	16
other	Hepatobiliary disorders	Hepatobiliary disorders	15 mg/kg	13	60	13
other	Hepatobiliary disorders	Hepatobiliary disorders	20 mg/kg	12	60	12
other	Immune system disorders	Immune system disorders	10 mg/kg	0	60	0

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	10 mg/kg
Total, all-cause mortality	15 mg/kg
Total, all-cause mortality	20 mg/kg
Total, other adverse events	10 mg/kg	26	60
Total, other adverse events	15 mg/kg	30	60
Total, other adverse events	20 mg/kg	21	60
Total, serious adverse events	10 mg/kg	2	60
Total, serious adverse events	15 mg/kg	1	60
Total, serious adverse events	20 mg/kg	5	60

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27567500	BACKGROUND	PubMed
28559269	RESULT	PubMed
40239986	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AI091429	Randomized Trial of High-Dose Rifampin in Patients with New Smear-Positive TB	MITNICK, CAROLE D.; DAVIES, GERAINT	HARVARD MEDICAL SCHOOL	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2011 to 2013

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01408914

GET https://conductscience.org/api/trials/v1/NCT01408914/events?page=2

API reference For AI assistants