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:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT00128193
Eligibility Criteria:
Inclusion Criteria:
All Subjects
* Between the ages of 18 and 60 years old
* Male or female; not less than 30 percent for one gender
* Agree to participate in the study after verbal explanation by the physician and nurses, as indicated by signing an informed consent form
* Weight greater than 30 Kg (female) and 38 Kg (male)
* Available for skin test readings
* Nepali residents, including expatriates from India
Healthy, Non-Contacts
* Healthy (determined by history and physical examination)
* No household or working contact with tuberculosis or leprosy patients
Contacts of Leprosy Patients
* Healthy (determined by history and physical examination)
* Household contact of a person with leprosy for at least 6 months duration, and within 6 months of this study, or a person professionally exposed to leprosy for at least 5 years duration, and within 6 months of this study
Persons with Leprosy
* Having one or more of the following symptoms:
1. Hypopigmented or erythematous skin lesion(s) with definite loss of sensation
2. Damage to the peripheral nerves as demonstrated by palpable thickening with or without impairment of sensation and/or weakness of the muscles of hands, feet or face
3. Presence of acid-fast bacilli in slit skin smears
4. Histological changes diagnostic of leprosy in skin biopsy
* Receiving standard multi drug treatment for leprosy or completed treatment for leprosy no more than 4 years prior to study enrollment
Persons with Tuberculosis
* Having active tuberculosis as defined by one of the following:
1. Extra-pulmonary tuberculosis if confirmed by culture
2. Pulmonary tuberculosis, defined as:
* Having a history of a productive cough of more than 3 weeks duration that may be accompanied by night sweats, loss of appetite, haemoptysis, weight loss, chest pain, or shortness of breath, and
* Having one or more of the following diagnostic criteria:
* Sputum smear-positive, defined as one or more of the following: at least 2 of 3 successive sputum samples positive for acid-fast bacilli by microscopy; or at least one sputum specimen positive and x-ray abnormalities consistent with pulmonary tuberculosis; or at least one positive sputum specimen that is culture positive for Mycobacterium tuberculosis
* Sputum smear-negative, defined as three sputum specimens negative for acid-fast bacilli but with x-ray evidence consistent with pulmonary tuberculosis and that does not clear with non-tuberculosis antibiotics; or three sputum samples negative for acid-fast bacilli by microscopy but culture positive for Mycobacterium tuberculosis
* Completed the intensive phase of chemotherapy for tuberculosis, but still undergoing the continuation phase of therapy
Exclusion Criteria:
All subjects
* Pregnant (as determined by a urine pregnancy test performed on females of child-bearing age on Day 0, prior to admission into the study) or lactating females
* Currently on oral corticosteroid or other immunosuppressive treatment
* Cancer, diabetes, or other chronic illness
* Extra-pulmonary tuberculosis not confirmed by culture
* Known hypersensitivities or allergies
* Expatriates other than those from India
* Participation in an earlier stage of this study
* Concurrent participation in another clinical trial
Healthy, Non-Contacts
* History of treated tuberculosis or leprosy
* Clinical signs of leprosy or tuberculosis
* Known contact with persons with leprosy or tuberculosis
Healthy Contacts of Leprosy Patients
* History of treated tuberculosis or leprosy
* Clinical signs of leprosy or tuberculosis
Persons with Leprosy
* Leprosy patients in reversal reaction or erythema nodosum leprosum (ENL) reaction or those being treated with corticosteroids or thalidomide for these conditions
* History of treated tuberculosis
* Clinical signs of tuberculosis
* Completed full course of standard multidrug treatment (MDT) for leprosy more than 4 years prior to study enrollment
Persons with Tuberculosis
* History of treated leprosy
* Clinical signs of leprosy
* Completed full course of standard tuberculosis treatment
* Known contact with leprosy patients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00128193
Study Brief:
Protocol Section:
NCT00128193