Efficacy and Safety of Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis
Condition: Cutaneous Leishmaniases
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

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).
    

Intervention name(s): Single dose of Pentamidine; Two doses of Pentamidine; Three doses of Pentamidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The patients will come to the hospital to take a single dose of the Pentamidine.; The patients will come to the hospital to take two doses of the Pentamidine, in interval of one week between them.; The patients will come to the hospital to take three doses of the Pentamidine, in interval of one week between them.
Other intervention name(s): Pentamidine (7mg/kg) in a single application.; Pentamidine (7mg/kg) in two weekly applications.; Pentacarinat® (7mg/kg) in three weekly applications
Intervention MeSH terms: Pentamidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cutaneous Leishmaniasis; pentamidine isothionate; treatment