Clin2
NCT02354014Possibly a fitRecruiting

Test drug levels and TB activity of TMC207 in children

Tuberculosis, Multidrug-Resistant

Treatments studied

Part of Infections clinical trials.

This study measures how TMC207 (an anti-TB medicine) works in the body and in combination with standard MDR-TB medicines for children and teens with lung MDR-TB. It may help clinicians learn the safest way to use TMC207 and how well it may support treatment.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
60 people
Ages
birth to 18 years
Study type
Interventional

Who can take part

  • Be a child from birth up to under 18 years old at screening
  • Weigh more than 3 kilograms and fit age-based growth ranges on WHO charts
  • Have confirmed or likely MDR-TB affecting the lungs, and/or a non-severe type outside the lungs
  • Start MDR-TB treatment on Day 1, or start within 12 weeks of Day 1, and be open to changing the plan for TMC207 use
  • Stop rifampin (RMP) at least 7 days before the baseline visit
  • Be willing to do HIV testing (and get the parent’s/ mother’s HIV testing if needed)

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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