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TuberculosisPhase 2REDUCE TBNCT07656012

Re-evaluating the Duration in Children of TB Treatment

A Phase 2 study testing Rifampicin, Isoniazid and Pyrazinamide in people with Tuberculosis, run by University of Wisconsin, Madison at 1 site in Peru.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Current tuberculosis (TB) treatment is effective (works well), but it takes a long time to cure TB. This study will evaluate if TB treatment with a higher dose of rifampicin, one of the TB medicines, and shorter TB treatment duration is as effective and safe as the standard, TB treatment (with the usual rifampicin… Read more about this study

Who is it for?
Ages 3 months to 9 years
Conditions the study is for
Tuberculosis
What is being tested?
Rifampicin, Isoniazid and Pyrazinamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 sitePeru
Study dates
Feb 2027to Feb 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 3 months to less than 10 years of age
  • Body weight greater than or equal to 3 kilograms (kg) and less than 45 kg at study entry
  • Confirmed or clinically diagnosed intrathoracic (pulmonary) and/or some forms of extrathoracic (extrapulmonary) drug-susceptible TB:
  • Confirmed intrathoracic (pulmonary) TB, based on chest radiograph and/or symptoms consistent with TB, and/or some forms of extrathoracic TB, with all of the following as determined by the site investigator:
  • Microbiological confirmation of M. tuberculosis from any clinical specimen by either culture or molecular methods
  • At least rifampicin-susceptibility demonstrated by genotypic (molecular) or phenotypic methods
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  • Documented clinical decision to treat for drug-susceptible TB
  • Clinically diagnosed intrathoracic (pulmonary) TB, based on chest radiograph and/or symptoms consistent with TB, and/or some forms of extrathoracic TB, with all of the following as determined by the site investigator:
  • Documented clinical decision to treat for drug-susceptible TB
  • HIV positive or negative
  • For participants living with HIV, they must be on a dolutegravir-based antiretroviral therapy regimen at the time of study entry

Who cannot join

  • Received routine treatment for TB disease for greater than 5 days at the time of enrollment
  • Exposure to a case of intrathoracic TB in the 12 months prior to enrollment with known or suspected resistance to any of the drugs in the treatment regimens OR confirmed resistance on molecular or phenotypic drug-susceptibility testing to any drugs in the treatment regimens
  • Has greater than or equal to grade 3 results of any of the following during screening: creatinine, serum ALT, AST, total bilirubin
  • Has hemoglobin less than 7.5 g/dL during screening
  • Has TB meningitis, osteoarticular TB, or miliary TB as determined by the site investigator
  • Severe renal, pulmonary, cardiac, gastrointestinal, neurologic or any other condition that in the judgement of the investigator would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
Show all 10Show fewer
  • Use of any prohibited drug within 3 days of enrollment
  • Severe acute malnutrition defined as weight-for-height/length z-score or BMI-for-age z-score less than -3
  • Hypersensitivity to any of the study drugs (rifampicin, isoniazid, pyrazinamide or ethambutol)
  • For Main Trial (Step 2) participants, previously enrolled in the Lead-in PK Study (Step 1)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

UW Clinical Trials Institute contact

608.265.3132

info@clinicaltrials.wisc.edu

Peru1 site

  • Socios en Salud Sucursal Peru

    Lima

    Leonid Lecca, MD

Other trials in Peru

About this study

Official title: Multi-arm, Open-label, Duration-randomized, Phase IIc Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Optimized Rifampicin in Combination With Isoniazid, Pyrazinamide, and Ethambutol for the Treatment of Children With Drug-susceptible Tuberculosis

Current tuberculosis (TB) treatment is effective (works well), but it takes a long time to cure TB. This study will evaluate if TB treatment with a higher dose of rifampicin, one of the TB medicines, and shorter TB treatment duration is as effective and safe as the standard, TB treatment (with the usual rifampicin dose and usual duration). This study hopes to find a better shorter treatment that works as well as the current treatment (standard of care). This could benefit children worldwide who are getting TB treatment.

Children 3 months to less than 10 years of age who have drug-susceptible TB (can be successfully treated with standard TB medicines) are eligible for this study.

Read the detailed description

This is a multi-arm open-label phase IIc trial with duration randomization, with a lead-in pharmacokinetics (PK) study. Children 3 months to less than 10 years of age with routinely diagnosed clinical or confirmed drug-susceptible TB will be screened and if eligible randomly assigned 1:1:1:1:1 to one of five arms (durations of TB treatment and control arm). Randomization will be stratified by age (3 months to less than 5 years of age vs 5 to less than 10 years of age).

A total of 200 participants will be enrolled in the main trial (Step 2), with 40 per study arm, with an additional 30 participants enrolled in a Lead-in PK study (Step 1).

Step 1 - Lead-in PK study participants will be on treatment for 8 weeks, complete their trial participation in up to 9 weeks, and will not contribute to the main trial endpoints.

Step 2 - Main trial participants will be on study for 48 weeks.

Primary Objective:

In children with drug-susceptible tuberculosis, with and without HIV:

  • To characterize the relationship between treatment duration of the experimental regimen and the proportion of participants with unfavorable treatment outcome at 48 weeks after randomization (i.e., the duration-response curve)

Secondary Objectives:

The secondary objectives of the Lead-In PK study are to

  • Characterize the safety and tolerability of two optimized doses of rifampicin with standard doses of isoniazid, pyrazinamide and ethambutol
  • Characterize the pharmacokinetics of two optimized doses of rifampicin
  • Characterize the acceptability of two optimized doses of rifampicin

The secondary objectives of the Main Study are to:

  • Characterize the safety and tolerability of optimized-dose rifampicin with standard doses of isoniazid, pyrazinamide and ethambutol
  • Characterize the pharmacokinetics of optimized-dose rifampicin
  • Characterize lung health post-TB treatment at week 48 among children able to complete lung-health assessments
  • Characterize the acceptability of optimized-dose rifampicin
Conditions
Tuberculosis
Being tested
Rifampicin, Isoniazid, Pyrazinamide, Ethambutol
Keywords
children, rifampicin, duration randomization
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RifampicinDrug

    Also called two optimized-doses (odR) rifampicin

    odR for main trial determined from Lead-in PK study 75 mg tablet, and 150 or 300 mg capsule, dosed by weight and age

  • IsoniazidDrug

    Also called Isoniazid (H)

    50 mg tablet, dosed by weight and age

  • PyrazinamideDrug

    Also called Pyrazinamide (Z)

    150 mg tablet, dosed by weight and age

  • EthambutolDrug

    Also called Ethambutol (E)

    100 mg tablet, dosed by weight and age

  • RifampicinDrug

    Also called standard dose rifampicin (R)

    standard of care and only the 75 mg tablet will be used

Study groups in NCT07656012
Study groupRoleWhat they receive
Arm 1: 8 week durationExperimentalN = 40, 8 weeks of odRHZE
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol
Arm 2: 11 week durationExperimentalN = 40, 8 weeks of odRHZE followed by 3 weeks of odRH
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol
Arm 3: 14 week durationExperimentalN = 40, 8 weeks of odRHZE followed by 6 weeks of odRH
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol
Arm 4: 17 week durationExperimentalN = 40, 8 weeks of odRHZE followed by 9 weeks of odRH
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol
Arm 5: Control (17 or 24 week duration)Active comparatorN = 40, 8 week of RHZ(E) followed by 9 weeks (5a - non-severe TB) or 16 weeks (5b - severe TB) of RH
Receives: Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol; Drug: Rifampicin
Step 1: PK - Dosing Schedule A > BExperimentalN = 15 * Period 1 - odRIF Dosing Schedule A with HZE, PK sampling after 4 weeks followed by * Period 2 - odRIF Dosing Schedule B with HZE, PK sampling after 4 weeks Dosing schedules are by weight and age, with Schedule A a higher dose of RIF (totaling 250 - 1650mg) than Schedule B (totaling 200 - 1350mg)
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol
Step 1: PK - Dosing Schedule B > AExperimentalN = 15 * Period 1 - odRIF Dosing Schedule B with HZE, PK sampling after 4 weeks followed by * Period 2 - odRIF Dosing Schedule A with HZE, PK sampling after 4 weeks Dosing schedules are by weight and age, with Schedule A a higher dose of RIF (totaling 250 - 1650mg) than Schedule B (totaling 200 - 1350mg)
Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Pyrazinamide; Drug: Ethambutol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Step 2: Unfavorable TB treatment outcome

    A participant has unfavorable treatment outcomes if they fail to meet either of the following criteria:

    • No treatment extension or re-treatment for TB at any time up through 48 weeks after randomization.
    • TB recurrence-free cure or Probable TB recurrence-free cure

    Measured: 48 weeks

Secondary outcomes (10)

  1. Step 1: Safety measured by occurrence of Grade 3 to 5 Adverse Events after the first dose of study treatment by period in Lead-in PK study

    Occurrence of at least one new or worsened Grade 3-5 Adverse Event (AE) after the first dose of study treatment by period.

    Measured: data collected from individual participants for 2 regimens of 4 weeks each, up to 8 weeks total

  2. Step 1: Tolerability Measured by discontinuation of at least one drug in Lead-in PK study

    Permanent discontinuation of at least one drug in the study regimen during each treatment period due to an AE of any grade that is either safety- or tolerability-related, death due to toxicity (probably/possibly/certainly) related to one or more of the study drugs, or participant/parent/guardian request.

    Measured: data collected from individual participants for 2 regimens of 4 weeks each, up to 8 weeks total

  3. Step 1: Pharmacokinetics of optimized-dose rifampicin: (AUC0-24)

    Area under the concentration time curve over 24 hours (AUC0-24)

    Measured: data collected at week 4 (and week 8) visit lead-in PK study; pre-dose (0 hour), 1, 2, 4, 8 and 24 hour post dose

  4. Step 1: Pharmacokinetics of optimized-dose rifampicin: (Cmax)

    Maximum concentration (Cmax)

    Measured: data collected at week 4 (and week 8) visit lead-in PK study; pre-dose (0 hour), 1, 2, 4, 8 and 24 hour post dose

  5. Step 1: Acceptability of optimized-dose rifampicin summarized by participant count

    Participant and/or parent/guardian responses to rifampicin acceptability question of "Overall, how did you/your child feel about taking this medicine?", scored on a likert scale from 1-5 with higher scores being more acceptable. Summarized by number of responses per score.

    Measured: baseline (at dose 1), week 4, week 8

  6. Step 2: Safety Measured by Occurrence of at least one new or worsened Grade 3-5 adverse event after the first dose of study treatment in Main Trial

    Occurrence of at least one new or worsened Grade 3-5 adverse event after the first dose of study treatment and during the 28 weeks following randomization, where 28 weeks is 4 weeks beyond the longest scheduled treatment duration of 24 weeks.

    Measured: up to 28 weeks

  7. Step 2: Tolerability Measured by discontinuation of at least one drug in Main Trial

    Permanent discontinuation of at least one drug in the study regimen prior to the end of the assigned treatment period due to an AE of any grade that is either safety- or tolerability-related, death due to toxicity (probably/possibly/certainly) related to one or more of the study drugs, or participant/parent/guardian request.

    Measured: up to 24 weeks

  8. Step 2: Lung function post-TB treatment

    The outcome of interest is abnormal lung function classified as having at least one of the following physiological findings based on results of spirometry and oscillometry (FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity):

    • Obstructive lung disease: defined as FEV1, or FEV1/FVC of <-1.64 z-score (z-score<-1.64 = lower limit of normal, LLN) with normal FVC
    • Restrictive lung disease: defined as FVC <-1.64 z-score with normal FEV1
    • Mixed lung disease: defined as FEV1/FVC <LLN;
    • Isolated small airway dysfunction: defined as oscillometry Area of reactance (AX) >1.64 z-score and/or oscillometry peripheral airway resistance (R5-20) >1.64 z-score with normal FEV1 on spirometry

    Measured: week 48

  9. Step 2: Acceptability of optimized-dose rifampicin summarized by participant count

    Participant and/or parent/guardian responses to rifampicin acceptability question of "Overall, how did you/your child feel about taking this medicine?", scored on a likert scale from 1-5 with higher scores being more acceptable. Summarized by number of responses per score.

    Measured: baseline (at dose 1), week 4, week 8

  10. Step 2: Acceptability of overall TB treatment regimen summarized by participant count

    Participant and/or parent/guardian responses to overall TB treatment regimen acceptability question of "In the last 4 weeks, how did you/your child feel about taking this TB treatment regimen, considering all of the TB medicines in the regimen together?", scored on a likert scale from 1-5 with higher scores being more acceptable. Summarized by number of responses per score.

    Measured: week 4, week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study startFeb 2027 (estimated)
  3. Primary completionFeb 2031 (estimated)
  4. Study completionFeb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multi-arm open-label phase IIc trial with duration randomization, with a lead-in PK study. Children 3 months to less than 10 years of age with routinely diagnosed clinical or confirmed drug-susceptible TB will be screened and if eligible randomly assigned 1:1:1:1:1 to one of five arms (durations of TB treatment and control arm). Randomization will be stratified by age (3 months to less than 5 years of age vs 5 to less than 10 years of age). A total of 200 participants will be enrolled in the main trial, with 40 per study arm, with an additional 30 participants enrolled in a Lead-in PK study that has a crossover trial design.
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07656012
Sponsor's protocol ID
2026-0205
Other IDs
Protocol Version 2/10/26, SMPH | Pediatrics - GPAM, 1U01AI192041-01
Acronym
REDUCE TB
Status last verified
Oct 2026
First submitted
15 May 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rifampicin, Isoniazid and Pyrazinamide in people with Tuberculosis, run by University of Wisconsin, Madison at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact UW Clinical Trials Institute (608.265.3132, info@clinicaltrials.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step 2: Unfavorable TB treatment outcome (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07656012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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