Clinical Trial: Treatment Duration for Abdominal Tuberculosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 (Exte

Brief 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 Summary:

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 tuberculosi
    Sponsor: All India Institute of Medical Sciences, New Delhi

    Current Primary Outcome:

    • Response to treatment (after 6 months and nine months of RNTCP Category I treatment) [ Time Frame: 1 year ]

      Intestinal tuberculosis:

      Complete response to treatment: Resolution of clinical manifestations, Healing of demonstrable lesions, Microbiological response (Conversion of positive to negative)

      Clinical failure: Failure of response to treatment:

      Persistence of clinical manifestations Persistence of morphological lesions

      Peritoneal tuberculosis: Definition for response Complete response: Complete resolution of ascites within 6 months No response: Persistence of ascites

    • 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 [ Time Frame: 1 year ]


    Original Primary Outcome:

    • Response to treatment (after 6 months and nine months of RNTCP Catagory I treatment) [ Time Frame: 1 year ]

      Intestinal tuberculosis:

      Complete response to treatment: Resolution of clinical manifestations, Healing of demonstrable lesions, Microbiological response (Conversion of positive to negative)

      Clinical failure: Failure of response to treatment:

      Persistence of clinical manifestations Persistence of morphological lesions

      Peritoneal tuberculosis: Definition for response Complete response: Complete resolution of ascites within 6 months No response: Persistence of ascites

    • 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 [ Time Frame: 1 year ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: All India Institute of Medical Sciences, New Delhi

    Dates:
    Date Received: May 3, 2010
    Date Started: July 2008
    Date Completion:
    Last Updated: July 2, 2015
    Last Verified: July 2015