Health Trials

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

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

Treatments tested in this trial

  • Rifampicin
  • Isoniazid
  • Pyrazinamide
  • Ethambutol
  • Rifampicin

Treatment groups

230 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Wisconsin, Madison

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov