High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

This study has been terminated.
(Low cure rate in the study (fluconazole) group)
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Bahia
Information provided by (Responsible Party):
Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT01953744
First received: September 25, 2013
Last updated: December 1, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Cutaneous Leishmaniasis
Drug: Fluconazole
Drug: Meglumine Antimoniate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis

Resource links provided by NLM:


Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • Cure rate or complete cicatrization of the ulcer. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.


Secondary Outcome Measures:
  • Initial cure rate or complete cicatrization of the ulcer [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.


Enrollment: 53
Study Start Date: February 2014
Study Completion Date: November 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluconazole
Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.
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.
Active Comparator: Meglumine Antimoniate
Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 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.
Other Name: Glucantime

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953744

Locations
Brazil
Posto de Saúde de Corte de Pedra
Presidente Tancredo Neves, Bahia, Brazil, 45416000
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Bahia
Investigators
Principal Investigator: Paulo Roberto Lima Machado, PhD University of Bahia
  More Information

Responsible Party: Paulo Roberto Lima Machado, Associate Researcher, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier: NCT01953744     History of Changes
Other Study ID Numbers: FlucoLBrBaMa 
Study First Received: September 25, 2013
Last Updated: December 1, 2015
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital Universitário Professor Edgard Santos:
Fluconazole; Meglumine antimoniate;L.Braziliensis;
L.Guyanensis

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Fluconazole
Meglumine antimoniate
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 28, 2016