NCT02919605

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

Efficacy and Safety of Single, Double and Triple Dose Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis: a Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · Academic / Other
• Sex: All
• Age: 16 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase II pilot study comprising 159 patients. The sample size was calculated for a study using a test of difference between proportion considering alpha and beta errors . With an estimated curing ratio of 80 % for group 3 Pentamidine applications 7 mg / kg group and the pentamidine at a dose of 7 mg / kg 58.1 % cure rate, with a significance level 95 % and a 80 % test power . Clinical and laboratory workup: Full body skin examination will be performed. Ulcerated lesions will be measured and pictured before treatment. Follow-up measurements and pictures were also taken one week, one, two and six months after treatment. Species identification was made through polymerase chain reaction (PCR) as described elsewhere. Two months after treatment, additional smears will be obtained from lesions that were not completely healed and/or showed an increase of, at least, 50% of its original dimensions. Other laboratory exams included complete blood count, sugar, AST, ALT, urea, creatinine and amylase blood levels, stool parasite examination, routine urine examination and rapid test for HIV. Drug administration: PI (300mg) was diluted in 5 ml of saline solution and a single IM injection (7 mg/kg) was administered at the outpatient unit of the FMT-HVD. Patients were given a carbohydrate enriched meal before treatment to prevent hypoglycemia and were kept at rest and under close clinical observation until one hour after medication. Rescue treatment with IV injections of antimonials (15 mg/kg every 20 days) was prescribed for those who fail to improve. Therapeutic failure was defined as the persistence of clinical signs (onset of new lesions, \>50% increase in the size of preexisting lesions) or laboratory findings (positive smears) two months after treatment or anytime during the follow-up period. Adverse effects will be classified as mild (drug-related, well tolerated, with no need of prescription for symptomatic relief); moderate (drug-related, symptomatic prescription required) and severe (clinically detectable impairment of renal, hepatic or cardiac functions).

Conditions

• Cutaneous Leishmaniases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2016-09-29
• Last updated: 2019-02-15