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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Treatments: Pentamidine

Criteria

Inclusion Criteria:

• Newly diagnosed cutaneous leishmaniasis (untreated) with localized lesions ( without maximum 6 injuries ) and Direct Examination positive : amastigotes display in tissue samples ;

• Age: 16-64 years;

• Sex: male and female patients to eligible ;

• Disease Clinical Evolution not longer than 3 months .

Exclusion Criteria:

• AST > 3 times the upper limit of normal;

• ALT > 3 times the upper limit of normal;

• Alkaline phosphatase > 3 times the upper limit of normal;

• Serum creatinine and urea > 1.5 times the upper limit of normality;

• Blood glucose above 110 mg / dl;

• Evidence of serious underlying disease ( heart , kidney , liver or lung);

• protein and / or caloric severe malnutrition;

• Any uncompensated or uncontrolled condition like active tuberculosis, malignant disease , severe malaria , HIV, leprosy , systemic fungal disease (histoplasmosis, paracoccidioidomycosis) or any other infectious disease;

• Pregnant women or who are breastfeeding;

• Lack of ability or willingness to provide informed consent (patient and / or parent / legal representative); lack of availability for the visits or to comply with study procedures.