MedTrace Logo

Liposomal Amphotericin in Disseminated Leishmaniasis

NCT02025491 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-01-01

No results posted yet for this study

Summary

Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40% of the cases.

DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to relevant drug toxicity, high morbidity due to a long lasting disease, with an important socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure rate than historic cure rates of pentavalent antimony in the treatment of disseminated leishmaniasis.

Conditions

  • Disseminated Leishmaniasis

Interventions

DRUG

Liposomal Amphotericin B

Liposomal Amphotericin B will be administered by intravenous route, 3 to 5 mg/kg/day, during 7 to 14 days of treatment. Complete hemogram, aminotransferases (AST, ALT), blood urea and creatinine will be determined in all patients on days -1, and three times/week up to the end of therapy. Patients will bemonitored for side effects daily. Patients will be followed-up at 1, 2, 3, 4 and 6 months post-therapy. Clinical and laboratory adverse events will be graded according to the Common Toxicity Criteria (CTC) of the National Cancer Institute.

Sponsors & Collaborators

  • Hospital Universitário Professor Edgard Santos

    lead OTHER

Principal Investigators

  • Paulo RL Machado, MD PhD · UFBA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-02-28
Completion
2013-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025491 on ClinicalTrials.gov