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Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis (PCL01)

Primary Purpose

Cutaneous Leishmaniasis

Status

Terminated

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Glucantime®

Zithromax ®

About this trial

This is an interventional treatment trial for Cutaneous Leishmaniasis focused on measuring cutaneous leishmaniasis, azithromycin, N- methyl glucamine

Eligibility Criteria

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

Inclusion Criteria:

Patients older than 14 and younger than 65 years old
Skin lesions with clinical suggestion of cutaneous leishmaniasis and positive leishmanin skin test(Montenegro test)or parasitological (direct observation of leishmania amastigotes, leishmania in vitro culture from aspirates, histopathological) and molecular(Polymerase Chain Reaction - PCR)samples.
No use of oral potentially antileishmanial drugs, or topics throughout the term of the current injury.
Absence of disseminated leishmaniasis.
Absence of mucosal involvement.
Agreement to participate in the study and signed the informed consent.

Exclusion Criteria:

Diabetes mellitus, kidney diseases, liver or cardiac diseases, tuberculosis, malaria.
Pregnancy
lactating mothers
Breast feeding
Cutaneous lesion with bacterial infection for which antibiotics need to be prescribed
More than six cutaneous lesions
Previous history of cutaneous or mucosal leishmaniasis
Use of drugs with potential pharmacological interactions with antimonials as anti-arrhythmic or tricycle anti-depressives
Previous intolerance to azithromycin or other macrolides or N-methylglucamine
Abusive alcohol ingestion according to the CAGE questionnaire

Sites / Locations

Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras
University Estadual de Montes Claros
Centro de Pesquisas René Rachou - Fiocruz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A - N- methyl glucamine

B - Azithromycin

Arm Description

Glucantime® , max day of 1,215 mg

Zithromax ® , one dose 500 mg

Outcomes

Primary Outcome Measures

Proportion of clinically cured patients

A cure was defined as complete lesion healing and re-epithelialization without inflammatory infiltration and erythema until 90 days after the treatment ended.

Secondary Outcome Measures

Proportion of patients with failure and cured

Proportion of cured patients at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment. Mean time to healing.

Occurrence of mucosal lesions after treatment

Proportion of patients with relapsed or mucosal lesion in 6 months, 9 and 12 follow-up after completion of treatment.

Proportion of patients presenting new lesions

Proportion of patients with new lesions at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment.

Proportion of adverse events on each treatment group

Proportion of patients clinical, electrocardiographic and laboratory adverse events.

Full Information

NCT ID

NCT00682656

First Posted

May 20, 2008

Last Updated

October 16, 2014

Sponsor

Ana Rabello

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT00682656

Brief Title

Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

Acronym

PCL01

Official Title

Open Label Randomized Study to Assess Safety and Efficacy of Azithromycin Versus Meglumine Antimoniate to Treat Cutaneous Leishmaniasis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Terminated

Why Stopped

Efficacy issues on test arm

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ana Rabello

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The adequate treatment of the American tegumentary leishmaniasis is crucial since the disease, differently from the caused by the Old World species, is painful and not self-healing and may lead to the disfiguring mucosal involvement. So far, pentavalent antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis (CL), however, these drugs present high frequency of side effects and important disadvantages as parenteral administration and need for careful renal and cardiac monitoring. Azithromycin is a macrolide antibiotic, non-expensive, largely commercially available that has shown in-vitro and in vivo activity against different species of Leishmania. The main objective of this study is to evaluate the efficacy and safety of oral azithromycin for the treatment of CL. The efficacy of oral treatment of azithromycin 500 mg/day for 20 days is going to be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (Glucantime®) for 20 days in patients with CL from two endemic regions of Brazil: the metropolitan region of Belo Horizonte and Montes Claros (MG)in the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow up lasts for 12 months.

Detailed Description

Included a new site (University Estadual de Montes Claros - UNIMONTES) in 7 June 2010. The site was included due the need to achieve more patients. The ANVISA (National Agency of Sanitary Surveillance) approved these site in March 2011 and the start of activities is planned for June 2011.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Leishmaniasis

Keywords

cutaneous leishmaniasis, azithromycin, N- methyl glucamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A - N- methyl glucamine

Arm Type

Active Comparator

Arm Description

Glucantime® , max day of 1,215 mg

Arm Title

B - Azithromycin

Arm Type

Experimental

Arm Description

Zithromax ® , one dose 500 mg

Intervention Type

Drug

Intervention Name(s)

Glucantime®

Other Intervention Name(s)

meglumine antimoniate

Intervention Description

15mg Sb+5/Kg/day, during 20 days. Maximum dose:15ml/day

Intervention Type

Drug

Intervention Name(s)

Zithromax ®

Other Intervention Name(s)

SELIMAX®

Intervention Description

Zithromax ®/ Pfizer, 500 mg - 1x day, during 20 days

Primary Outcome Measure Information:

Title

Proportion of clinically cured patients

Description

A cure was defined as complete lesion healing and re-epithelialization without inflammatory infiltration and erythema until 90 days after the treatment ended.

Time Frame

at the third month after treatment

Secondary Outcome Measure Information:

Title

Proportion of patients with failure and cured

Description

Proportion of cured patients at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment. Mean time to healing.

Time Frame

twelve months after treatment

Title

Occurrence of mucosal lesions after treatment

Description

Proportion of patients with relapsed or mucosal lesion in 6 months, 9 and 12 follow-up after completion of treatment.

Time Frame

twelve months after treatment

Title

Proportion of patients presenting new lesions

Description

Proportion of patients with new lesions at 1, 2, 3, 6, 9 and 12 follow-up after completion of treatment.

Time Frame

1st 2nd 3rd 6th 12th month after treatment

Title

Proportion of adverse events on each treatment group

Description

Proportion of patients clinical, electrocardiographic and laboratory adverse events.

Time Frame

1st 2nd 3rd 6th 12th month after treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients older than 14 and younger than 65 years old Skin lesions with clinical suggestion of cutaneous leishmaniasis and positive leishmanin skin test(Montenegro test)or parasitological (direct observation of leishmania amastigotes, leishmania in vitro culture from aspirates, histopathological) and molecular(Polymerase Chain Reaction - PCR)samples. No use of oral potentially antileishmanial drugs, or topics throughout the term of the current injury. Absence of disseminated leishmaniasis. Absence of mucosal involvement. Agreement to participate in the study and signed the informed consent. Exclusion Criteria: Diabetes mellitus, kidney diseases, liver or cardiac diseases, tuberculosis, malaria. Pregnancy lactating mothers Breast feeding Cutaneous lesion with bacterial infection for which antibiotics need to be prescribed More than six cutaneous lesions Previous history of cutaneous or mucosal leishmaniasis Use of drugs with potential pharmacological interactions with antimonials as anti-arrhythmic or tricycle anti-depressives Previous intolerance to azithromycin or other macrolides or N-methylglucamine Abusive alcohol ingestion according to the CAGE questionnaire

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana Rabello, MD PhD

Organizational Affiliation

Oswaldo Cruz Foundation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Isabela Ribeiro, MD

Organizational Affiliation

Drugs for Neglected Diseases

Official's Role

Study Director

Facility Information:

Facility Name

Núcleo de Medicina Tropical University of Brasília - Health Center Corte de Pedras

City

Presidente Tancredo Neves

State/Province

Bahia

ZIP/Postal Code

45416-000

Country

Brazil

Facility Name

University Estadual de Montes Claros

City

Montes Claros

State/Province

ZIP/Postal Code

39401-002

Country

Brazil

Facility Name

Centro de Pesquisas René Rachou - Fiocruz

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30190-002

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

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