Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

NCT ID: NCT03294161

Last Updated: 2017-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-06-30

Brief Summary

A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the treatment of Cutaneous Leishmaniasis in Bahia, Brazil.

Detailed Description

The treatment of cutaneous leishmaniasis caused by L. braziliensis in Brazil with pentavalent antimony is associated with a high rate of failure, reaching up to 45% of cases. Additionally, pentavalent antimony is only administered by parenteral route with important toxicity and ulcer lesion healing takes a long time, from 2 to 3 months.

So, this randomized and controlled clinical trial was designed to compare the efficacy and safety of standard antimonial (20mg/day /kg for 20 days) associated with Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use versus standard antimonial (20mg/kg/day for 20 days) associated with placebo for topical use in the treatment of Cutaneous Leishmaniasis and Early Cutaneous Leishmaniasis caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia, Brazil.

Conditions

Leishmaniasis; Leishmaniasis, Cutaneous; Leishmaniasis; American

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immucillin DI4G

Meglumine Antimoniate by intravenous route at 20mg/kg/day during 20 days + Immucillin DI4G 2% by topical use once a day at the ulcer for 20 days .

Group Type: EXPERIMENTAL

Immucillin DI4G

Intervention Type: DRUG

Immucillin DI4G was administered by topical use at 2% concentration once a day for 20 days associated with Meglumine antimoniate administered by intravenous route at a dosage of 20mg/kg/day, during 20 days.

Meglumine Antimoniate

Meglumine Antimoniate by intravenous route at 20mg/kg/day during 20 days + placebo for topical use once a day at the ulcer for 20 days.

Group Type: ACTIVE_COMPARATOR

Meglumine antimoniate

Intervention Type: DRUG

Placebo for topical use once a day at the ulcer for 20 days associated with Meglumine antimoniate administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.

Interventions

Immucillin DI4G

Immucillin DI4G was administered by topical use at 2% concentration once a day for 20 days associated with Meglumine antimoniate administered by intravenous route at a dosage of 20mg/kg/day, during 20 days.

Intervention Type: DRUG

Meglumine antimoniate

Placebo for topical use once a day at the ulcer for 20 days associated with Meglumine antimoniate administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.

Intervention Type: DRUG

Other Intervention Names

Fourth-generation Immucillin Derivative; Glucantime

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed (untreated) cutaneous leishmaniasis or early cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
• Number of lesions: 1 to 3 ulcerative lesions.
• Lesion´s diameter: 1 to 5 cm.
• Disease duration: up to three months.

Exclusion Criteria

• Aspartate aminotransferase, alanine aminotransferase >3 times upper limit of normal range
• Serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range
• Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
• Immunodeficiency or antibody to HIV
• Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
• Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
• Negative parasitology (aspirate/biopsy/PCR) or negative Montenegro test
• Any history of prior anti-leishmania therapy
• Any condition which compromises ability to comply with the study procedures
• Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
• Anticipated non-availability for study visits/procedure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Federal University of Bahia

OTHER

Sponsor Role: collaborator

Pontificia Universidade Católica do Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Hospital Universitário Professor Edgard Santos

OTHER

Sponsor Role: lead

Responsible Party

Fernanda V Prates, MD, MSc

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edgar M Carvalho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Paulo RL Machado, MD, PhD

Role: STUDY_CHAIR

Federal University of Bahia

Locations

Corte de Pedra Health Post

Corte de Pedra, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

Immucillin DI4GTrial

Identifier Type: -

Identifier Source: org_study_id