Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Trial to Compare Effectiveness of 4 Months Rifampin (4 RIF) With 9 Months Isoniazid (9 INH) in the Prevention of Active TB in Children: The P4v9 Trial
Brief Summary: Tuberculosis (TB) is spread by airborne transmission from adults with active contiguous TB to children, especially those living in the same household. Once children are exposed and infected they are at very high risk to develop active TB - which can be lethal if not detected and treated promptly. This makes it very important to detect TB infection as soon as possible, and treat this while it is still latent or dormant. Current therapy for latent TB infection is 9 months of Isoniazid; this is very effective if taken properly but because treatment is so long many children do not finish this. Four months of Rifampin is a recommended alternative. In adults this has been shown to be safer with much higher completion rates. However the effectiveness of this treatment is unclear, and is being studied in an ongoing study. The investigators plan to compare the safety as well as the acceptability and effectiveness of 4 months Rifampin with 9 months Isoniazid (standard treatment) in children in several sites in Canada and other countries.

It is hypothesized that among children at high risk for development of active TB, intolerance/adverse events will not be worse (non-inferiority), among those randomized to 4RIF compared to those randomized to 9INH. In addition completion of latent tuberculosis infection (LTBI) therapy will be significantly greater (superiority), and subsequent rates of active TB will not be significantly higher (non-inferiority) in children taking 4RIF.


Options:
A: Arm Label: HIVneg/INH; Type: EXPERIMENTAL; Interventions: Drug: Isoniazid (INH), Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX) | Arm Label: HIVneg/PL; Type: PLACEBO_COMPARATOR; Interventions: Drug: Isoniazid Placebo (PL) | Arm Label: HIVpos/INH; Type: EXPERIMENTAL; Interventions: Drug: Isoniazid (INH), Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX) | Arm Label: HIVpos/PL; Type: PLACEBO_COMPARATOR; Interventions: Drug: Isoniazid Placebo (PL) | Intervention Type: DRUG; Name: Isoniazid (INH); Assigned to Arm(s): HIVneg/INH, HIVpos/INH | Intervention Type: DRUG; Name: Trimethoprim/Sulfamethoxazole (TMP/SMX); Assigned to Arm(s): HIVneg/INH, HIVpos/INH | Intervention Type: DRUG; Name: Isoniazid Placebo (PL); Assigned to Arm(s): HIVneg/PL, HIVpos/PL
B: Arm Label: Isoniazid preventive therapy; Type: EXPERIMENTAL; Interventions: Drug: Isoniazid, Drug: Cotrimoxazole | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Cotrimoxazole, Other: placebo | Intervention Type: DRUG; Name: Isoniazid; Assigned to Arm(s): Isoniazid preventive therapy | Intervention Type: DRUG; Name: Cotrimoxazole; Assigned to Arm(s): Isoniazid preventive therapy, Placebo | Intervention Type: DRUG; Name: isoniazid; Assigned to Arm(s): Isoniazid preventive therapy | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Placebo
C: Arm Label: Isoniazid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Isoniazid | Arm Label: Rifampin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rifampin | Intervention Type: DRUG; Name: Isoniazid; Assigned to Arm(s): Isoniazid | Intervention Type: DRUG; Name: Rifampin; Assigned to Arm(s): Rifampin
D: Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Isoniazid | Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rifampin | Intervention Type: DRUG; Name: Isoniazid; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Rifampin; Assigned to Arm(s): A

Answer: C