Status:
COMPLETED
Leprosy Skin Test Antigens Trial
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Leprosy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the nu...
Detailed Description
This double-blind Phase II clinical trial will be conducted in 3 stages to evaluate 2 new leprosy skin test antigens, Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) and M. le...
Eligibility Criteria
Inclusion
- 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:
- Hypopigmented or erythematous skin lesion(s) with definite loss of sensation
- 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
- Presence of acid-fast bacilli in slit skin smears
- 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:
- Extra-pulmonary tuberculosis if confirmed by culture
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00128193
Start Date
April 1 2002
End Date
September 1 2009
Last Update
December 24 2014
Active Locations (6)
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1
Colorado State University - Microbiology, Immunology & Pathology
Fort Collins, Colorado, United States, 80523
2
Anandaban Hospital
Kathmandu, Nepal
3
Green Pastures Hospitals
Kathmandu, Nepal
4
Lalitpur Nursing Campus
Kathmandu, Nepal