Shortened Regimen for Drug-susceptible TB in Children
Trial Parameters
Brief Summary
While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.
Eligibility Criteria
Inclusion Criteria: * Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee/Institutional Review Board (EC/IRB) policies and procedures, potential participant is willing and able to provide assent for study participation. * At Entry, age of less than 10 years. * At Entry, weight 3 kilograms (kg) or greater. * At Entry, diagnosed with TB disease, defined as: * Pulmonary (including pleural effusion) and/or lymph node (extra-thoracic and/or intra-thoracic) TB with or without bacteriologic confirmation; * Clinician has decided to treat with standard first-line drug-susceptible TB regimen. * Known HIV status or HIV testing in progress based on meeting testing requirements. * Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent): * Alanine aminotransferase (ALT) less than or equal to 5 times the upper l