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Antibiotic

Short-course TB Drug Regimens for Tuberculosis (CRUSH-TB Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Centers for Disease Control and Prevention
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For participants with HIV: current use of dolutegravir-based ART (Anti Retroviral Therapy), or ability and willingness to start or transition to a dolutegravir-based antiretroviral therapy regimen
Documentation of negative HIV status within the past 3 months prior to enrollment or documentation confirming HIV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks and 12 weeks
Awards & highlights

CRUSH-TB Trial Summary

This trial tests whether 2 x 17-week regimens of TB drugs are as effective as the standard 6-month regimen. 288 male/female participants will be followed up to 78 weeks post-randomization.

Who is the study for?
This trial is for individuals with pulmonary tuberculosis, including those with HIV if their CD4 count is above 100 cells/mm3. Participants must be at least 12 years old, have a negative pregnancy test if applicable, and agree to use reliable contraception. Exclusion criteria include certain heart conditions, inability to take oral meds, recent TB treatment or drug resistance.Check my eligibility
What is being tested?
The study tests two short-course treatments against standard six-month therapy for TB. One group receives bedaquiline, moxifloxacin, pyrazinamide plus rifabutin (BMZRB) for four months; another gets the same drugs plus delamanid (BMZD). The control group follows the conventional regimen of isoniazid and rifampin (2HRZE/4HR).See study design
What are the potential side effects?
Potential side effects may include liver issues due to Rifabutin and Delamanid; nerve damage from Isoniazid; digestive problems from Pyrazinamide; tendon damage from Moxifloxacin; blood disorders from Bedaquiline. Ethambutol can cause vision issues while Rifampin may lead to flu-like symptoms.

CRUSH-TB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on or willing to start dolutegravir-based HIV treatment.
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I have recent proof of my HIV status, whether negative or positive.
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My CD4 T cell count is at least 100 cells/mm3.
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I am 12 years old or older.
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I am a woman who is not surgically sterilized or post-menopausal and have a recent negative pregnancy test.
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I have tuberculosis in my lungs, possibly affecting other areas except my brain or bones.
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I need some help but can take care of most of my personal needs.

CRUSH-TB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to sputum culture negative in liquid media after study treatment among participants in Experimental Regimens (2 BZMRb/ 2 BMRb, Arm 1) and (2 BMZD/ 2 BMD, Arm 2) compared to Control (2HRZE/4HR, Arm 3) in modified intention-to-treat group (ITT)
Secondary outcome measures
All-cause study drug discontinuation among participants in experimental regimens compared to control regimen
Clearance of bedaquiline
Proportion of participants with sputum culture negative by 8 weeks and by 12 weeks (solid and liquid media) in all 3 regimens
+6 more

CRUSH-TB Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 2BMZRb/2 BMRbExperimental Treatment4 Interventions
Eight weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), plus rifabutin (Rb), followed by nine weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered once daily. Study drug doses: Bedaquiline (B): 200 mg once daily x 56 days, then 100 mg daily; Moxifloxacin (M): 400 mg once daily; Pyrazinamide (Z) 1500 mg (weight <75kg) or 2000mg(> 75kg) once daily x 56 days; Rifabutin (Rb): 300 mg once daily
Group II: 2 BMZD/2 BMDExperimental Treatment4 Interventions
Eight weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), plus delamanid (D or DLM) followed by nine weeks of daily treatment with bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered once daily. Study drug doses: Bedaquiline (B): 200 mg once daily x 56 days, then 100 mg daily; Moxifloxacin (M): 400 mg once daily; Pyrazinamide (Z) 1500 mg (weight <75kg) or 2000mg(> 75kg) once daily x 56 days; Delamanid (D):300 mg once daily
Group III: 2RHZE/4RHActive Control4 Interventions
Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by eighteen weeks of daily treatment with rifampin and isoniazid All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered once daily study drug doses: Rifampin (R), 600 mg daily; Isoniazid (H), 300 mg daily; Pyrazinamide (Z) 1500 mg (weight <75kg) or 2000mg(> 75kg) once daily ; Ethambutol, 15 mg/kg once daily rounded up to nearest 400 mg dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifabutin
2003
Completed Phase 4
~890
Delamanid
2016
Completed Phase 3
~1570
Bedaquiline
2020
Completed Phase 3
~3350
Moxifloxacin
2013
Completed Phase 4
~3290
Pyrazinamide
2013
Completed Phase 3
~4610

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionLead Sponsor
875 Previous Clinical Trials
22,477,114 Total Patients Enrolled
38 Trials studying Tuberculosis
72,090 Patients Enrolled for Tuberculosis
Tuberculosis Trials ConsortiumNETWORK
Ekaterina V Kurbatova, MD, PhD, MPHStudy ChairCenters for Disease Control and Prevention
1 Previous Clinical Trials
2,516 Total Patients Enrolled
1 Trials studying Tuberculosis
2,516 Patients Enrolled for Tuberculosis

Media Library

Bedaquiline (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766267 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to enroll in this clinical trial at present?

"The available data on clinicaltrials.gov indicates that this medical trial is not presently enrolling patients, despite its original post date being March 1st 2023 and a subsequent edit taking place the following day. Fortunately, 167 other trials are still actively recruiting at this time."

Answered by AI

How widely distributed is this trial taking place?

"The trial is enrolling participants from a variety of locations, such as TBTC Site 64 Brooklyn Campus of the VA NY Harbor Healthcare System in Brooklyn, New york; TBTC Site 64A New York City Department of Health and Mental Hygiene- Corona Chest Center in Jackson Heights, Texas; and TBTC Site 63 San Antonio VA Medical Center (South Texas Group) in San Antonio, Washington. These 3 sites are among 15 others that have been selected for this research endeavour."

Answered by AI

Who else is applying?

What site did they apply to?
TBTC Site 77 CAB-V. Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

If I can be of help in any way Iam here.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Short-course Regimens for the Treatment of Pulmonary Tuberculosis
2023. "Short-course Regimens for the Treatment of Pulmonary Tuberculosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766267.
All > Tuberculosis
~192 spots leftby Oct 2025
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