Tuberculosis Clinical Trial
— RNTCP-DOTSOfficial 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.
Status | Completed |
Enrollment | 197 |
Est. completion date | April 2014 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Dr Govind K Makharia | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi | Christian Medical College, Vellore, India, Sanjay Gandhi Postgraduate Institute of Medical Sciences |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to treatment (after 6 months and nine months of RNTCP Category I treatment) | 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 |
1 year | No |
Primary | 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 | 1 year | No |
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