Treatment Duration for Abdominal Tuberculosis

NCT01124929 | Completed Phase 3 DMC

• 1 other identifier: Abdominal TB_RCT (RNTCP-DOTS)
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Intestinal tuberculosis; Tuberculous peritonitis; Abdominal tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Arm 1: Category I treatment for 6 months

ACTIVE COMPARATOR

Anti-tuberculosis drugs

Drug: RNTCP Category I treatment for 6 months

Arm 2: Category I treatment for 9 months

ACTIVE COMPARATOR

Anti-tuberculosis drugs,

Drug: RNTCP Category I treatment for 9months

Interventions

RNTCP Category I treatment for 6 months DRUG

2H3R3Z3 E3 + 4H3R3

Arm 1: Category I treatment for 6 months

RNTCP Category I treatment for 9months DRUG

2H3R3Z3 E3 + 7H3R3

Arm 2: Category I treatment for 9 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Sanjay Gandhi Postgraduate Institute of Medical Sciences: collaborator
• Christian Medical College, Vellore, India: collaborator

Study Sites (1)

Dr Govind K Makharia

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

• Makharia GK, Ghoshal UC, Ramakrishna BS, Agnihotri A, Ahuja V, Chowdhury SD, Gupta SD, Mechenro J, Mishra A, Mishra A, Pathak MK, Pandey RM, Sharma R, Sharma SK. Intermittent Directly Observed Therapy for Abdominal Tuberculosis: A Multicenter Randomized Controlled Trial Comparing 6 Months Versus 9 Months of Therapy. Clin Infect Dis. 2015 Sep 1;61(5):750-7. doi: 10.1093/cid/civ376. Epub 2015 May 12.

  PMID: 25969531 DERIVED

MeSH Terms

Conditions

Tuberculosis; Peritonitis, Tuberculous

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tuberculosis, Extrapulmonary; Peritonitis; Intraabdominal Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Dr Govind K Makharia, MD, DM, DNB

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 18, 2010
• Study Start: July 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: April 1, 2014
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

IN (1)