High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus
NCT ID: NCT01953744
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
53 participants
INTERVENTIONAL
2014-02-28
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fluconazole
Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.
Fluconazole
Fluconazole is presented in 150mg capsules and will be administered by oral route at a dosage of 6-8mg/kg/day during 28 days.
Meglumine Antimoniate
Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.
Meglumine Antimoniate
Meglumine Antimoniate will be administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.
Interventions
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Fluconazole
Fluconazole is presented in 150mg capsules and will be administered by oral route at a dosage of 6-8mg/kg/day during 28 days.
Meglumine Antimoniate
Meglumine Antimoniate will be administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Number of lesions: 1 to 3 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Federal University of Bahia
OTHER
Hospital Universitário Professor Edgard Santos
OTHER
Responsible Party
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Paulo Roberto Lima Machado
Associate Researcher
Principal Investigators
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Paulo Roberto Lima Machado, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bahia
Locations
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Posto de Saúde de Corte de Pedra
Presidente Tancredo Neves, Estado de Bahia, Brazil
Countries
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References
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Prates FV, Dourado ME, Silva SC, Schriefer A, Guimaraes LH, Brito MD, Almeida J, Carvalho EM, Machado PR. Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial. Clin Infect Dis. 2017 Jan 1;64(1):67-71. doi: 10.1093/cid/ciw662. Epub 2016 Nov 1.
Other Identifiers
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FlucoLBrBaMa
Identifier Type: -
Identifier Source: org_study_id