Shortened Regimen for Drug-susceptible TB in Children

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-9
SponsorJohns Hopkins University

About this trial

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

Qualifiers

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.

Pulmonary (including pleural effusion) and/or lymph node (extra-thoracic and/or intra-thoracic) TB with or without bacteriologic confirmation;

Disqualifiers

Presumed or documented extra-pulmonary TB involving the central nervous system and/or bones and/or joints, and/or miliary TB, and/or pericardial TB and/or TB of the gastrointestinal (GI) tract and/or renal TB.

Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry.

Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs;

Any prohibited medications within three days prior to Entry or planned use within the following 6 months;

Trial design

Treatments tested in this trial

  • Isoniazid
  • Rifampin
  • Pyrazinamide
  • Ethambutol
  • Rifapentine
  • Moxifloxacin

Treatment groups

860 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

United States Agency for International Development (USAID)

Collaborator