High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Hospital Universitário Professor Edgard Santos
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: NA
Last verified: September 2013
History: No changes posted
  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.


Estimated Enrollment: 140
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (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
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

Contacts
Contact: Paulo Roberto MD Lima Machado, PhD 55-71-3237735 prlmachado@hotmail.com
Contact: Nicolaus Albert MD Borges Schriefer 55-71-32455493 aschriefer@globo.com

Locations
Brazil
Posto de Saúde de Corte de Pedra Not yet recruiting
Presidente Tancredo Neves, Bahia, Brazil, 45416000
Contact: Mayra Dourado    55-73-35535092    mayradourado@hotmail.com   
Contact: Ednaldo Lago    55-73-35535092    ednaldo-lago@ig.com.br   
Sub-Investigator: Silvana Conceição da Silva, Biologist         
Sub-Investigator: Mayra Elizabeth Dourado, Nurse         
Sub-Investigator: Maria das Graças Brito, Doctor         
Sub-Investigator: Luiz Henrique Guimarães, Doctor         
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

No publications provided

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: September 25, 2013
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
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 22, 2014