Amphotericin B Treatment in Visceral Leishmaniasis | NCT00310505

Studies
Amphotericin B Treatment in Visceral Leishmaniasis

NCT00310505

Sponsor

Banaras Hindu University

Status

Completed

Last Update Posted

Sep 12, 2008Estimated

Enrollment

1,500

Phase

Not Applicable

Conditions

Visceral Leishmaniasis

Interventions

Amphotericin B deoxycholate given as daily administration

Countries

India

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

Sep 2008

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

Jan 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 3, 2006

First Submission Date that Met QC Criteria

Apr 3, 2006

First Posted Date

Apr 4, 2006Estimated

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

Sep 11, 2008

Last Update Posted Date

Sep 12, 2008Estimated

Description Module

Brief Summary

This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

Detailed Description

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500

Name	Type	Description	Arm Group Labels	Other Names
Amphotericin B deoxycholate given as daily administration	Drug

Measure	Description	Time Frame
Final cure rate at six months after the end of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parasitologically proved kala-azar

Exclusion Criteria:

HIV positive serology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shyam Sundar, MD	Professor of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kala-azar Medical Research Center		Muzaffarpur	Bihar	221005	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17682988	Derived	Sundar S, Chakravarty J, Rai VK, Agrawal N, Singh SP, Chauhan V, Murray HW. Amphotericin B treatment for Indian visceral leishmaniasis: response to 15 daily versus alternate-day infusions. Clin Infect Dis. 2007 Sep 1;45(5):556-61. doi: 10.1086/520665. Epub 2007 Jul 23.

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