Treatment Duration for Abdominal Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): RNTCP Category I treatment for 6 months; RNTCP Category I treatment for 9months
Intervention type(s): Drug; Drug
Intervention description(s): 2H3R3Z3 E3 + 4H3R3; 2H3R3Z3 E3 + 7H3R3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intestinal tuberculosis; Tuberculous peritonitis; Abdominal tuberculosis