Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis - Full Text View

Sponsors and Collaborators:	University of Brasilia Ministery of Health, Brazil
Information provided by:	University of Brasilia
ClinicalTrials.gov Identifier:	NCT00317980

Purpose

The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.

Condition	Intervention	Phase
Cutaneous Leishmaniasis	Drug: Meglumine antimoniate	Phase IV

MedlinePlus related topics: Leishmaniasis

Drug Information available for: Meglumine Glucantime

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis

Further study details as provided by University of Brasilia:

Primary Outcome Measures:

Proportion of clinically cured patients at the third month after treatment [ Time Frame: Three months after treatment ] [ Designated as safety issue: No ]
Proportion of patients with epithelialized lesions [ Time Frame: Three months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with adherence to the protocol prescribed drug [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Proportion of patients with adverse events [ Time Frame: 30 days after treatment ] [ Designated as safety issue: Yes ]
Proportion of patients with late failure after the first three months of follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	280
Study Start Date:	February 2006
Estimated Study Completion Date:	June 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low dose: Experimental Meglumine antimoniate 5 mg/kg/d for 20 days	Drug: Meglumine antimoniate Meglumine antimoniate 5mg/kg/d for 20 days
Standard dose: Active Comparator Meglumine antimoniate 15 mg/kg/d for 20 days	Drug: Meglumine antimoniate Meglumine antimoniate 15 mg/kg/d for 20 days

Detailed Description:

The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent. Recently, some research developed in Brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen. That evidence has been obtained in patients from the State of Rio de Janeiro who were infected by Leishmania (Viannia) braziliensis. The purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by Leishmania (Viannia) braziliensis living in a rural area of the State of Bahia, Brazil, where cutaneous leishmaniasis is highly endemic. The usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs.

The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes:

Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 5 mg/kg/d intravenous for 20 days
Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 15 mg/kg/d intravenous for 20 days

The clinical outcomes of cure or failure will be evaluated until the third month of follow-up.

Eligibility

Ages Eligible for Study:	7 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis
Disease duration of 2 to 20 weeks
Positive leishmanin skin test
Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp

Exclusion Criteria:

History of past episode of leishmaniasis
Mucosal disease
Disseminated disease
Use of drugs with anti-leishmanial activity
Contraindications for using pentavalent antimony:
- pregnancy
- renal failure
- heart failure
- hepatic failure
Other diseases:
- active tuberculosis
- hanseniasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317980

Locations

Brazil, Distrito Federal
Núcleo de Medicina Tropical, University of Brasilia
Brasilia, Distrito Federal, Brazil, 70904-970

Sponsors and Collaborators

University of Brasilia

Ministery of Health, Brazil

Investigators

Principal Investigator:

Gustavo S Romero, MD

University of Brasilia

More Information

Publications:

Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens. Pathol Biol (Paris). 1997 Jun;45(6):496-9.

Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. A low-dose antimony treatment in 159 patients with American cutaneous leishmaniasis: extensive follow-up studies (up to 10 years). Am J Trop Med Hyg. 1997 Dec;57(6):651-5.

Responsible Party:	Nucleo de Medicina Tropical, University of Brasilia ( Gustavo S Romero MD )
Study ID Numbers:	NMT-LD-CP-2006
Study First Received:	April 21, 2006
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00317980
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by University of Brasilia:

Cutaneous leishmaniasis
Leishmania braziliensis
Pentavalent antimony
Meglumine antimoniate

Study placed in the following topic categories:

Leishmaniasis
Protozoan Infections
Skin Diseases, Infectious
Skin Diseases

Meglumine antimoniate
Parasitic Diseases
Leishmaniasis, Cutaneous

Additional relevant MeSH terms:

Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Skin Diseases, Parasitic

Therapeutic Uses
Sarcomastigophora Infections
Mastigophora Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009