Rifampin Versus Isoniazid for the Treatment of Latent Tuberculosis Infection in Children (P4v9)
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
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.