NCT02025491

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

December 26, 2013

Last Update Submit

December 30, 2013

Conditions

Disseminated Leishmaniasis

Keywords

Disseminated leishmaniasisLiposomal Amphotericin BLeishmania braziliensis

Outcome Measures

Primary Outcomes (1)

  • Definitive cure

    Definitive cure at 3 months after the end of treatment is defined as complete epithelialization of all ulcers and complete disappearance of inflammatory infiltrations from all lesions.

    3 months after treatment

Secondary Outcomes (1)

  • Toxicity

    During the 7 to 15 days of treatment

Study Arms (1)

Liposomal Amphotericin

EXPERIMENTAL

Liposomal Amphotericin by intravenous route, 3 to 5 mg/kg/day, during 7 to 14 days of treatment.

Drug: Liposomal Amphotericin B

Interventions

Liposomal Amphotericin BDRUG

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.

Also known as: Ambisome
Liposomal Amphotericin

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a) clinical diagnosis of Disseminated Leishmaniasis according to case definition; b) illness duration of less than three months, c) parasite identification by culture or polymerase chain reaction methods, d) no previous treatment for leishmaniasis.

You may not qualify if:

  • a) immunodeficiency or antibodies to HIV, b) pregnancy or patients not willing or unable to use contraceptives during and 3 months after the end of therapy c) ALT, AST ≥3x normal reference values, creatinine and BUN ≥1.5x normal reference values, d) any evidence of serious underlying disease (cardiac, renal, hepatic, or pulmonary) including serious infection other than DL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUPES

Salvador, Estado de Bahia, 40000, Brazil

Location

Related Publications (1)

  • Machado PR, Rosa ME, Guimaraes LH, Prates FV, Queiroz A, Schriefer A, Carvalho EM. Treatment of Disseminated Leishmaniasis With Liposomal Amphotericin B. Clin Infect Dis. 2015 Sep 15;61(6):945-9. doi: 10.1093/cid/civ416. Epub 2015 Jun 5.

    PMID: 26048961DERIVED

MeSH Terms

Interventions

liposomal amphotericin B

Study Officials

  • Paulo RL Machado, MD PhD

    UFBA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 26, 2013

First Posted

January 1, 2014

Study Start

April 1, 2011

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations

BR(1)