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Re-evaluating the Duration in Children of TB Treatment

ConditionTuberculosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-9
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rifampicin

    Drug

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

  • Isoniazid

    Drug

    50 mg tablet, dosed by weight and age

  • Pyrazinamide

    Drug

    150 mg tablet, dosed by weight and age

  • Ethambutol

    Drug

    100 mg tablet, dosed by weight and age

  • Rifampicin

    Drug

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

Treatment groups

230 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Arm 1: 8 week durationExperimental treatment 4 interventions
Group B: Arm 2: 11 week durationExperimental treatment 4 interventions
Group C: Arm 3: 14 week durationExperimental treatment 4 interventions
Group D: Arm 4: 17 week durationExperimental treatment 4 interventions
Group E: Arm 5: Control (17 or 24 week duration)Active comparator 4 interventions
Group F: Step 1: PK - Dosing Schedule A > BExperimental treatment 4 interventions
Group G: Step 1: PK - Dosing Schedule B > AExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

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

Time frame
48 weeks

Secondary outcomes

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.

Time frame
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.

Time frame
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)

Time frame
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)

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: