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

NCT02919605 | Completed Phase 2 DMC

• 1 other identifier: CAAE - 0016.0.114.0000-10
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cutaneous Leishmaniasis; pentamidine isothionate; treatment

Outcome Measures

Primary Outcomes (1)

• Number of patients with reduction in 50% in the diameters of the ulcers and lesions skin

  Two months after the end of the treatment

Secondary Outcomes (1)

• Number of patients with complete healing in the diameters of the ulcers and lesions skin

  Six months after the end of the treatment

Study Arms (3)

Single dose of Pentamidine

EXPERIMENTAL

Fifty three patients using Pentamidine at a dose of 7 mg/kg will be included, in a single dose.

Drug: Single dose of Pentamidine

Two doses of Pentamidine

EXPERIMENTAL

Fifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during two weeks.

Drug: Two doses of Pentamidine

Three doses of Pentamidine

EXPERIMENTAL

Fifty three patients using Pentamidine at a dose of 7 mg/kg, in a weekly dose, during three weeks.

Drug: Three doses of Pentamidine

Interventions

Single dose of Pentamidine DRUG

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.

Single dose of Pentamidine

Two doses of Pentamidine DRUG

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.

Two doses of Pentamidine

Three doses of Pentamidine DRUG

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

Three doses of Pentamidine

Eligibility Criteria

• Age: 16 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundação de Medicina Tropical Dr. Heitor Vieira Dourado: lead

Related Publications (1)

• Gadelha EPN, Ramasawmy R, da Costa Oliveira B, Morais Rocha N, de Oliveira Guerra JA, Allan Villa Rouco da Silva G, Gabrielle Ramos de Mesquita T, Chrusciak Talhari Cortez C, Chrusciak Talhari A. An open label randomized clinical trial comparing the safety and effectiveness of one, two or three weekly pentamidine isethionate doses (seven milligrams per kilogram) in the treatment of cutaneous leishmaniasis in the Amazon Region. PLoS Negl Trop Dis. 2018 Oct 31;12(10):e0006850. doi: 10.1371/journal.pntd.0006850. eCollection 2018 Oct.

  PMID: 30379814 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzamidines; Amidines; Organic Chemicals

Study Officials

• Anette Talhari, Doctor

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: September 29, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share