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Treatment Duration for Abdominal Tuberculosis

NCT01124929 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2015-07-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

RNTCP Category I treatment for 6 months

2H3R3Z3 E3 + 4H3R3

DRUG

RNTCP Category I treatment for 9months

2H3R3Z3 E3 + 7H3R3

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    collaborator OTHER_GOV

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Dr Govind K Makharia, MD, DM, DNB · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-07-31
Completion
2014-04-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124929 on ClinicalTrials.gov