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High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

NCT01953744 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2015-12-02

No results posted yet for this study

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.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Federal University of Bahia

    collaborator OTHER

  • Hospital Universitário Professor Edgard Santos

    lead OTHER

Principal Investigators

  • Paulo Roberto Lima Machado, PhD · University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-04-30
Completion
2015-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01953744 on ClinicalTrials.gov