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:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT01536795
Eligibility Criteria:
Inclusion Criteria: The study population will be selected from adults (18y) patients and children above 15y in Tunisia (Old World)
* Age: 15 - 75 years old
* Lesion character: each diameter (horizontal and vertical) of the lesion test must measure 7 mm, the lesion must be primarily ulcerative (i.e., not verrucous or nodular) and located in a biopsy friendly site of the body
* Parasitological diagnosis: have cutaneous leishmaniasis proven parasitologically in lesion selected for inclusion in study (lesion test).
* Informed consent: have given written informed consent to participate in the study: (i.e. patient or legal representative).
Exclusion Criteria:
* Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides in the patient or immediate family members.
* Previous use of antileishmanial drugs (within 2 months) or present use of routinely nephrotoxic or ototoxic drugs.
* Potential for follow up: Have less than 4 months time remaining in present address and/or plans to leave the area for more than 30 days.
* Extent of disease: More than 10 lesions or lesion ³ 5 cm or a lesion less than 2 cm from eye, in the ear, or a lesion in the face, that in the opinion of the attending dermatologist could potentially cause significant disfigurement.
* Location of disease: mucosal involvement.
* Disseminated disease: clinically significant lymphadenitis with nodules that are painful and \> 1 cm in size in the lymphatic drainage of the ulcer.
* Concomitant medical problems: significant medical problems of the kidney or liver as determined by history and by the following laboratory studies:
* Kidney: clinically significant abnormalities of urine analysis, serum levels of Creatinine, BUN, total proteins \> upper limit of normal for the laboratory.
* Liver: AST or ALT \> upper limit of normal for the laboratory.
* General: glucose, Na, K, \> upper limit of normal or \< lower limit of normal for the laboratory. Volunteers in whom these normal laboratory values are exceeded by less than 25% will not be automatically excluded. These volunteers will be evaluated on the basis of history, physical, as well as laboratory values.
* Scheduled or ongoing pregnancy as determined clinical and biological criteria.
* Presence of signs or symptoms of peripheral neuropathy, myasthenia gravis or neuromuscular block
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01536795
Study Brief:
Protocol Section:
NCT01536795