Status:
COMPLETED
Efficacy and Safety Study of Immunomodulator as an Adjunct Therapy in Pulmonary Tuberculosis (TB) Retreatment Patients
Lead Sponsor:
Ministry of Science and Technology, India
Conditions:
Tuberculosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to study the efficacy and safety of Mycobacterium in treating patients with lung tuberculosis . Mycobacterium is a strain of bacterium which is used as a vaccine and an adj...
Detailed Description
Mycobacterium w is a recently introduced immunomodulator, which has been found to be useful in rapid killing of Mycobacterium leprae. It improves the clearance of Mycobacterium leprae from the body an...
Eligibility Criteria
Inclusion
- Patients who are sputum positive for pulmonary tuberculosis and who have been treated previously for more than 1 month as per the RNTCP/WHO guidelines.
- Category II inclusion will mean all those patients who are Treatment after Default/Treatment Failure/Treatment Relapse.
- Patients who are willing to give written informed consent.
Exclusion
- Patients who are known to be hypersensitive to those ATTs being administered.
- Patients co-infected with HIV, hepatitis B or hepatitis C.
- Pregnant and lactating females or females of child bearing age with a urine HCG positive result 24-48 hours prior to every injection of Mw till 8 weeks.
- Patients with abnormal renal function, liver function or hematological tests.
- Seriously ill and moribund patients with complications such as low lung reserve, marked tachypnoea, chronic cor pulmonale, congestive heart failure.
- Severely malnourished patients with body mass index (BMI) \< 15
- Severe hypoalbuminemia.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT00265226
Start Date
March 1 2005
End Date
March 1 2011
Last Update
January 6 2014
Active Locations (8)
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1
Mahavir Hospital
Hyderabad, Andhra Pradesh, India, 500004
2
Smt NHL Municipal Medical College & B.J. Medical College
Ahmedabad, Gujarat, India, 380006
3
National Tuberculosis Institute
Bangalore, Karnataka, India, 560 003
4
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029