High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus (NCT01953744) | Clinical Trial Compass
TerminatedPhase 3
High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus
Stopped: Low cure rate in the study (fluconazole) group
Brazil53 participantsStarted 2014-02
Plain-language summary
The purpose of this study is to evaluate the therapeutic response to fluconazole in patients with cutaneous leishmaniasis caused by and L.(V.)guyanensis and L.(V.) braziliensis.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 3 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.
Exclusion Criteria:
* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
* Immunodeficiency or antibody to HIV
* Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
* Lack of suitability for the trial:
* Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
* Any history of prior anti-leishmania therapy
* Any condition which compromises ability to comply with the study procedures
* Administrative reasons:
* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedures
What they're measuring
1
Cure rate or complete cicatrization of the ulcer.
Timeframe: 6 months
Trial details
NCT IDNCT01953744
SponsorHospital Universitário Professor Edgard Santos