Safety and Efficacy of Low-Dose Pentavalent Antimony for Treatment of Cutaneous Leishmaniasis (Lowdosesb)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by:
University of Brasilia
ClinicalTrials.gov Identifier:
NCT00317980
First received: April 21, 2006
Last updated: January 20, 2009
Last verified: January 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Study Completion Date: December 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
Meglumine antimoniate 5 mg/kg/d for 20 days
Drug: Meglumine antimoniate
Meglumine antimoniate 5mg/kg/d for 20 days
Other Name: Glucantime
Active Comparator: Standard dose
Meglumine antimoniate 15 mg/kg/d for 20 days
Drug: Meglumine antimoniate
Meglumine antimoniate 15 mg/kg/d for 20 days
Other Name: Glucantime

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
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: NCT00317980

Locations
Brazil
Núcleo de Medicina Tropical, University of Brasilia
Brasilia, Distrito Federal, Brazil, 70904-970
Sponsors and Collaborators
University of Brasilia
Ministry of Health, Brazil
Investigators
Principal Investigator: Gustavo S Romero, MD University of Brasilia
  More Information

Publications:
Responsible Party: Gustavo S Romero MD, Nucleo de Medicina Tropical, University of Brasilia
ClinicalTrials.gov Identifier: NCT00317980     History of Changes
Other Study ID Numbers: NMT-LD-CP-2006
Study First Received: April 21, 2006
Last Updated: January 20, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Brasilia:
Cutaneous leishmaniasis
Leishmania braziliensis
Pentavalent antimony
Meglumine antimoniate

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine antimoniate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014