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High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

Primary Purpose

Cutaneous Leishmaniasis

Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Fluconazole
Meglumine Antimoniate
Sponsored by
Hospital Universitário Professor Edgard Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Leishmaniasis focused on measuring Fluconazole; Meglumine antimoniate;L.Braziliensis;, L.Guyanensis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Posto de Saúde de Corte de Pedra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fluconazole

Meglumine Antimoniate

Arm Description

Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.

Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.

Outcomes

Primary Outcome Measures

Cure rate or complete cicatrization of the ulcer.
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
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.

Full Information

First Posted
September 25, 2013
Last Updated
December 1, 2015
Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT01953744
Brief Title
High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus
Official Title
Phase 3 Randomized Trial Comparing Fluconazole to Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by L. Braziliensis and L. Guyanensis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Low cure rate in the study (fluconazole) group
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitário Professor Edgard Santos
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis
Keywords
Fluconazole; Meglumine antimoniate;L.Braziliensis;, L.Guyanensis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluconazole
Arm Type
Experimental
Arm Description
Fluconazole will be administered by oral route at 6-8mg/kg/day during 28 days.
Arm Title
Meglumine Antimoniate
Arm Type
Active Comparator
Arm Description
Meglumine Antimoniate will be administered by intravenous route at 20mg/kg/day during 20 days.
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
Fluconazole is presented in 150mg capsules and will be administered by oral route at a dosage of 6-8mg/kg/day during 28 days.
Intervention Type
Drug
Intervention Name(s)
Meglumine Antimoniate
Other Intervention Name(s)
Glucantime
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cure rate or complete cicatrization of the ulcer.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Initial cure rate or complete cicatrization of the ulcer
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Roberto Lima Machado, PhD
Organizational Affiliation
University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Posto de Saúde de Corte de Pedra
City
Presidente Tancredo Neves
State/Province
Bahia
ZIP/Postal Code
45416000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27803094
Citation
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.
Results Reference
derived

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High Dose Fluconazole in Cutaneous Leishmaniasis in Bahia and Manaus

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