Status:
COMPLETED
Efficacy and Safety of Immunomodulator as an Adjunct Therapy in New Pulmonary Tuberculosis(Category I) 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 evaluate the efficacy and safety of Mycobacterium w in new lung tuberculosis patients. Mycobacterium w is a strain of bacterium which is being used as vaccine and adjunc...
Detailed Description
Mycobacterium w is a recently introduced immunomodulator ,which has been found to be useful in rapid killing of Mycobacterium leprae. It improves clearance of Mycobacterium leprae from body and is the...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients of either sex aged between 18 to 60 yrs.
- Newly diagnosed sputum positive pulmonary TB cases with at least 2 sputum samples that are positive on sputum microscopy (Negative, Scanty, Scanty may be enrolled.
- Patients who are willing to give an informed consent.
- Exclusion Criteria
- Known hypersensitivity to Category I anti-TB drugs on history at the time of Screening.
- Known history of DR-TB (includes MDR-TB and XDR-TB) at the time of screening. Patients with Mtb isolate resistant to one or more drugs are to be excluded.
- Presence of secondary immunodeficiency states: HIV, organ transplantation, diabetes mellitus, malignancy, treatment with corticosteroids (illicited on detailed history and lab investigations).
- Hepatitis B and C positivity.
- Patients with known extrapulmonary TB and/or patients requiring surgical intervention.
- Currently receiving cytotoxic therapy, or have received it within the last 3 months- Ask on History.
- Pregnancy and lactation on history.
- Patients with a known seizure disorder on history.
- Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease on history.
- Patients with abnormal renal function (Serum creatinine more than 1.5 or proteinuria more than 2+ )
- Patients with abnormal hepatic functions (bilirubin = 1.5 mg/dl; AST, ALT, SAP more than 1.5 x ULN; PT = 1.3x control)
- Patients with hematological abnormalities (WBC lesser than or equal to 3000/mm3; platelets less than or equal to 100,000/mm3).
- Seriously ill and moribund patients with complications:
- low lung reserve, marked tachypnoea, chronic cor pulmonale, congestive cardiac failure, BMI\<15,
- severe hypoalbuminemia (\< 2.5 g/dl).
- Patients unlikely to survive for less than 6 months.
- Patients unable to comply with the treatment regimen.
- Patients with history of alcohol or drug abuse- to be asked for on history and assessed using the CAGE Questions. The patient should be asked four questions in the following manner. A positive response to any of the following questions will be considered an exclusion criterion.
- i. Have you ever felt a need to CUT DOWN your drinking?
- ii. Have you ever felt ANGRY when confronted about the amount of alcohol you drink?
- iii. Have you ever felt GUILTY when confronted about the amount of alcohol you drink?
- iv. Have you ever felt the need to have a drink first thing in the morning? (EYE OPENER).
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00341328
Start Date
March 1 2007
End Date
March 1 2012
Last Update
April 26 2013
Active Locations (2)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
2
Central JALMA Institute of Leprosy and Other Mycobacterial Diseases
Agra, India, 282001