Treatment Duration for Abdominal Tuberculosis

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborators: Christian Medical College, Vellore, India; Sanjay Gandhi Postgraduate Institute of Medical Sciences

Criteria

Inclusion criteria:

• Newly diagnosed patients with Intestinal TB or Peritoneal TB

• Has not received ATT for Tuberculosis any where in the body during past 5 years

• Patients having good general health and not too sick.

• Patients willing and likely to comply with the study procedures and follow up

• Patients should give informed consent.

Exclusion Criteria:

• Eighteen year is a cut off age for definition of adult and pediatric and adolescent medicine. The dosing of drugs are different in these two age groups. Therefore we plan to include patients of more than 18 years of age with abdominal TB in this study.

• Intake of ATT during the past 5 years

• Doubtful diagnosis

• Crohn's disease

• Patients with HIV and AIDS may have another systemic opportunistic infections including GI infections like cryptosporidiosis, Microsporidiosis or isosporiasis. There may be an overlap of GI manifestations such as diarrhea, abdominal pain, anemia, fever. Therefore, assessment of response to anti-tuberculosis therapy may be blurred. In order to keep the study group homogenous for comparison, we plan to exclude all those with HIV infection

• Chronic Liver Disease

• Associated significant co-morbidities

• H/O Sensitivity

• Peritoneal carcinomatosis

• Patients must not been used investigational agents during the past 6 months

• Unwilling patient