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Treatment Duration for Abdominal Tuberculosis (RNTCP-DOTS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Christian Medical College, Vellore, India
Information provided by (Responsible Party):
Govind K Makharia, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01124929
First received: May 3, 2010
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Treatment Duration for Abdominal Tuberculosis
Drug: RNTCP Category I treatment for 6 months
Drug: RNTCP Category I treatment for 9months
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 (Extension for 3 Months) in Abdominal Tuberculosis Under the Revised National Tuberculosis Control Program

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Response to treatment (after 6 months and nine months of RNTCP Category I treatment) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 212
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: RNTCP Category I treatment for 6 months Drug: RNTCP Category I treatment for 6 months
2H3R3Z3 E3 + 4H3R3
Active Comparator: Arm 2: RNTCP Cat I treatment for 9 months
In arm II patients will be given antituberculous therapy for 9 months
Drug: RNTCP Category I treatment for 9months
2H3R3Z3 E3 + 7H3R3

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124929

Contacts
Contact: Dr Govind K Makharia, MD, DM, DNB 011-26588091 govindmakharia@aiims.ac.in

Locations
India
Dr Govind K Makharia Recruiting
New Delhi, Delhi, India, 110029
Contact: Dr Uday Ghoshal, MD, DNB, DM    00919628842456    ghoshal@sgpgi.ac.in   
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Christian Medical College, Vellore, India
Investigators
Principal Investigator: Dr Govind K Makharia, MD, DM, DNB All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Govind K Makharia, Additional Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01124929     History of Changes
Other Study ID Numbers: Abdominal TB_RCT (RNTCP-DOTS)
Study First Received: May 3, 2010
Last Updated: December 12, 2011
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Intestinal tuberculosis
Tuberculous peritonitis
Abdominal tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 20, 2014