NCT00317980

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

2.1 years

First QC Date

April 21, 2006

Last Update Submit

January 20, 2009

Conditions

Cutaneous Leishmaniasis

Keywords

Cutaneous leishmaniasisLeishmania braziliensisPentavalent antimonyMeglumine antimoniate

Outcome Measures

Primary Outcomes (2)

  • Proportion of clinically cured patients at the third month after treatment

    Three months after treatment

  • Proportion of patients with epithelialized lesions

    Three months after treatment

Secondary Outcomes (3)

  • Proportion of patients with adherence to the protocol prescribed drug

    30 days

  • Proportion of patients with adverse events

    30 days after treatment

  • Proportion of patients with late failure after the first three months of follow-up

    12 months

Study Arms (2)

Low dose

EXPERIMENTAL

Meglumine antimoniate 5 mg/kg/d for 20 days

Drug: Meglumine antimoniate

Standard dose

ACTIVE COMPARATOR

Meglumine antimoniate 15 mg/kg/d for 20 days

Drug: Meglumine antimoniate

Interventions

Meglumine antimoniateDRUG

Meglumine antimoniate 5mg/kg/d for 20 days

Also known as: Glucantime
Low dose

Eligibility Criteria

Age7 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Núcleo de Medicina Tropical, University of Brasilia

Brasília, Federal District, 70904-970, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 9309267BACKGROUND

  • 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. doi: 10.4269/ajtmh.1997.57.651.

    PMID: 9430521BACKGROUND

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Meglumine Antimoniate

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsHexosaminesAmino SugarsCarbohydrates

Study Officials

  • Gustavo S Romero, MD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2006

First Posted

April 25, 2006

Study Start

February 1, 2006

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations

BR(1)