A Phase 2 interventional study of Single dose of Pentamidine and Two doses of Pentamidine in Cutaneous Leishmaniases, sponsored by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Completed. Open to participants aged 16 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · Phase 2, Interventional, and Treatment
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.
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).
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's enrollment of 159 is above the median of 80 across 133 interventional studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →Fundação de Medicina Tropical Dr. Heitor Vieira Dourado is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fifty three patients using Pentamidine at a dose of 7 mg/kg will be included, in a single dose.
Drug: Single dose of Pentamidine
Fifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during two weeks.
Drug: Two doses of Pentamidine
Fifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during three weeks.
Drug: Three doses of Pentamidine
The patients will come to the hospital to take a single dose of the Pentamidine.
Also known as: Pentamidine (7mg/kg) in a single application.
The patients will come to the hospital to take two doses of the Pentamidine, in interval of one week between them.
Also known as: Pentamidine (7mg/kg) in two weekly applications.
The patients will come to the hospital to take three doses of the Pentamidine, in interval of one week between them.
Also known as: Pentacarinat® (7mg/kg) in three weekly applications
Number of patients with reduction in 50% in the diameters of the ulcers and lesions skin
Time frame: Two months after the end of the treatment
Number of patients with complete healing in the diameters of the ulcers and lesions skin
Time frame: Six months after the end of the treatment
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Fundação de Medicina Tropical Dr. Heitor Vieira Dourado