Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is
sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular
meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis
use antituberculous therapy for 9 months, sometimes even 12 months without any scientific
justification. In a randomized controlled trial, Balasubramaniam et al reported no difference
in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy)
in the treatment of abdominal tuberculosis.
Although Directly Observed Therapy (DOTs) have been proved to be effective in patients with
pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on
efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis.
Therefore, there is an urgent need to establish the efficacy of DOTs strategy of
antituberculous therapy in the treatment of abdominal tuberculosis.
Therefore, the investigators planned to conduct a multicenter randomized controlled trial to
determine the difference in the recurrence of disease after only observation for three months
and three months extension of DOTs in a subset of patients with definite clinical response
after 6 months of DOTs.
Phase:
Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi
Collaborators:
Christian Medical College, Vellore, India Sanjay Gandhi Postgraduate Institute of Medical Sciences