Amphotericin B to Treat Visceral Leishmaniasis in Brazili... | NCT01032187

Studies
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

NCT01032187

Sponsor

University of Brasilia

Status

Completed

Last Update Posted

Sep 5, 2017Actual

Enrollment

101Actual

Phase

Phase 4

Conditions

Visceral Leishmaniasis

Interventions

Meglumine antimoniate
Amphotericin B-deoxycholate

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Dec 14, 2009

First Submission Date that Met QC Criteria

Dec 14, 2009

First Posted Date

Dec 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2017

Last Update Posted Date

Sep 5, 2017Actual

Name	Class
Ministry of Health, Brazil	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if amphotericin B is effective against visceral leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate which is the current approved drug used for this disease in Brazil.

Detailed Description

Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate or amphotericin B deoxycholate. All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Meglumine antimoniate	Active Comparator	20mg/kg/day IV for 20 days	Drug: Meglumine antimoniate
Anfo B	Experimental	Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days	Drug: Amphotericin B-deoxycholate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meglumine antimoniate	Drug	20mg/kg/day IV for 20 days	Meglumine antimoniate

Measure	Description	Time Frame
Cure rate		3 months

Measure	Description	Time Frame
Improvement rate		30 days
Adverse events rate		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical symptoms of visceral leishmaniasis: fever plus hepatomegaly or splenomegaly
Diagnosis of visceral leishmaniasis confirmed through parasite visualization in bone marrow smears or positive serology (indirect immunofluorescent antibody test or rK39 rapid test)or positive kDNA PCR test

Exclusion Criteria:

Any of the following laboratory findings
- Total serum bilirubin higher than 2,5 mg/dL
- Serum SGOT higher than 5 times the upper normal level
- Serum SGPT higher than 5 times the upper normal level
- Prothrombin time concentration lower than 70%
- Abnormal serum creatinine
Any of the following signs or symptoms
- Generalized edema
- Severe malnutrition
- Systemic inflammatory response syndrome
Any of the following conditions
- HIV infection/disease
- Diabetes
- Corticoid or immunosuppressive drugs use
- Symptomatic heart diseases
- Chronic hepatic or renal diseases
- Lupus erythematosus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Myrlena RM Borges, MsC	Federal University of Tocantins	Principal Investigator
Gustavo AS Romero, PhD	University of Brasilia	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Doenças Tropicais		Araguaína	Tocantins		Brazil
Hospital Dona Regina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28327804	Result	Borges MM, Pranchevicius MC, Noronha EF, Romero GA, Carranza-Tamayo CO. Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil. Rev Soc Bras Med Trop. 2017 Jan-Feb;50(1):67-74. doi: 10.1590/0037-8682-0455-2016.

ID	Term
D007896	Leishmaniasis
D056986	Euglenozoa Infections
D011528	Protozoan Infections
D010272	Parasitic Diseases

ID	Term
D000077485	Meglumine Antimoniate
C059765	amphotericin B, deoxycholate drug combination
D000666	Amphotericin B

ID	Term
D008536	Meglumine
D013012	Sorbitol
D013402	Sugar Alcohols
D000438	Alcohols
D009930