Tuberculosis Clinical Trial
Official title:
A Multi-centric Study on Treatment of Abdominal Tuberculosis (Intestinal or Peritoneal): A Randomized Controlled Trial to Compare the 6 Months of Cat I Treatment With 9 Months of Cat I Treatment (Extension for 3 Months) in Abdominal Tuberculosis Under the Revised National Tuberculosis Control Program
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.
Rationale 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 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. The aim of the present study is
not to assess the efficacy of DOTs but whether the Cat I regimen for 6 months is effective
in the treatment of abdominal tuberculosis. We, therefore planned to conduct a multicenter
randomized controlled trial to determine the difference in the efficacy and recurrence rate
in 6months and 9 months of intermittent short course category I regimen under RNTCP.
Hypothesis There may not be a significant difference in the efficacy and recurrence rate of
abdominal tuberculosis in those treated for six months vs those treated for 9 months with
intermittent short course category I regimen under RNTCP.
Objectives
Primary objectives:
1. To determine the efficacy of intermittent short course chemotherapy for 6 months under
Directly Observed Therapy (Category I under RNTCP) in treatment of abdominal
tuberculosis (proportion of patients responding to treatment)
2. To determine difference in the recurrence of disease between the two randomized groups
after only observation for three months and extension of RNTCP Cat I for three months
in a subset of patients with definite clinical response after 6 months of DOTs
Secondary objective
1. To study the effect of anti-tubercular drugs on the natural history of intestinal
stricture due to tuberculosis Outcomes
Outcome measures:
Primary:
1. Response to treatment (6 months and nine months of RNTCP Cat I treatment) as defined
earlier
2. Recurrence of symptoms of abdominal tuberculosis (intestinal and peritoneal) after 1
year of follow up in those who receive 6 months or 9 months of Cat I treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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