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Efficacy and Safety of Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis

NCT02919605 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2019-02-15

No results posted yet for this study

Summary

Introduction: Up to the present, have been few studies with pentamidine in the Americas; and there is no consensus regarding the dose used.

Objectives: To evaluate the use of pentamidine in single dose, double and triplo in the treatment of cutaneous leishmaniasis.

Methods: Clinical trial of phase II pilot study with 159 patients. Pentamidine will be used at a dose of 7 mg/kg, in three arms: single dose, double dose and triple dose. They will be also assessed the safety and adverse effects. The sic will be reviewed one, two and six months after the end of the treatments.

Conditions

  • Cutaneous Leishmaniases

Interventions

DRUG

Single dose of Pentamidine

The patients will come to the hospital to take a single dose of the Pentamidine.

DRUG

Two doses of Pentamidine

The patients will come to the hospital to take two doses of the Pentamidine, in interval of one week between them.

DRUG

Three doses of Pentamidine

The patients will come to the hospital to take three doses of the Pentamidine, in interval of one week between them.

Sponsors & Collaborators

  • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

    lead OTHER

Principal Investigators

  • Anette Talhari, Doctor · Researcher

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919605 on ClinicalTrials.gov