Ivermectin Versus Albendazole for Chronic Strongyloidiasis

This study is enrolling participants by invitation only.

First Received on September 30, 2008. Last Updated on June 18, 2010 History of Changes

Sponsor:	Mahidol University
Collaborator:	Atlantic Laboratory Ltd
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00765024

Purpose

A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.

Condition	Intervention	Phase
Chronic Strongyloidiasis	Drug: Ivermectin Drug: ivermectin Drug: Albendazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis

Resource links provided by NLM:

Drug Information available for: Albendazole Ivermectin

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

cure rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Albendazole Albendazole for 7 days	Drug: Albendazole Albendazole 7 days
Experimental: ivermectin ivermectin 200 mcg/kg single dose	Drug: Ivermectin single dose of 200 mcg/kg Other Name: stromectal
Experimental: ivermectin 2 doses ivermectin 200 mcg/kg two doses in 2 weeks	Drug: ivermectin two single dose of 200mcg/kg in 2 weeks Other Name: stromectal

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with positive strongyloides larva in the stool

Exclusion Criteria:

Pregnancy
Lactating women
Known allergy to any study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765024

Locations

Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700

Sponsors and Collaborators

Mahidol University

Atlantic Laboratory Ltd

Investigators

Principal Investigator:

Yupin Suputtamongkol, MD

Mahidol University

More Information

No publications provided by Mahidol University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Suputtamongkol Y, Premasathian N, Bhumimuang K, Waywa D, Nilganuwong S, Karuphong E, Anekthananon T, Wanachiwanawin D, Silpasakorn S. Efficacy and safety of single and double doses of ivermectin versus 7-day high dose albendazole for chronic strongyloidiasis. PLoS Negl Trop Dis. 2011 May 10;5(5):e1044.

Responsible Party:	Mahidol University, Faculty of Medicine Siriraj Hospital
ClinicalTrials.gov Identifier:	NCT00765024 History of Changes
Other Study ID Numbers:	TM001-2008
Study First Received:	September 30, 2008
Last Updated:	June 18, 2010
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

strongyloidiasis, ivermectin, albendazole

Additional relevant MeSH terms:

Strongyloidiasis
Rhabditida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Ivermectin
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics

Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012