Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT00341328
Eligibility Criteria:
Inclusion Criteria
1. Patients of either sex aged between 18 to 60 yrs.
2. 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.
3. Patients who are willing to give an informed consent.
Exclusion Criteria
1. Known hypersensitivity to Category I anti-TB drugs on history at the time of Screening.
2. 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.
3. Presence of secondary immunodeficiency states: HIV, organ transplantation, diabetes mellitus, malignancy, treatment with corticosteroids (illicited on detailed history and lab investigations).
4. Hepatitis B and C positivity.
5. Patients with known extrapulmonary TB and/or patients requiring surgical intervention.
6. Currently receiving cytotoxic therapy, or have received it within the last 3 months- Ask on History.
7. Pregnancy and lactation on history.
8. Patients with a known seizure disorder on history.
9. Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease on history.
10. Patients with abnormal renal function (Serum creatinine more than 1.5 or proteinuria more than 2+ )
11. Patients with abnormal hepatic functions (bilirubin = 1.5 mg/dl; AST, ALT, SAP more than 1.5 x ULN; PT = 1.3x control)
12. Patients with hematological abnormalities (WBC lesser than or equal to 3000/mm3; platelets less than or equal to 100,000/mm3).
13. Seriously ill and moribund patients with complications:
1. low lung reserve, marked tachypnoea, chronic cor pulmonale, congestive cardiac failure, BMI\<15,
2. severe hypoalbuminemia (\< 2.5 g/dl).
14. Patients unlikely to survive for less than 6 months.
15. Patients unable to comply with the treatment regimen.
16. 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00341328
Study Brief:
Protocol Section:
NCT00341328