- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00765024
Ivermectin Versus Albendazole for Chronic Strongyloidiasis
September 3, 2017 updated by: Mahidol University
Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bangkok
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Bangkoknoi, Bangkok, Thailand, 10700
- Siriraj hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with positive strongyloides larva in the stool
Exclusion Criteria:
- Pregnancy
- Lactating women
- Known allergy to any study drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Albendazole
Albendazole for 7 days
|
Albendazole 7 days
|
Experimental: ivermectin
ivermectin 200 mcg/kg single dose
|
single dose of 200 mcg/kg
Other Names:
|
Experimental: ivermectin 2 doses
ivermectin 200 mcg/kg two doses in 2 weeks
|
two single dose of 200mcg/kg in 2 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cure rate
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yupin Suputtamongkol, MD, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
September 30, 2008
First Submitted That Met QC Criteria
September 30, 2008
First Posted (Estimate)
October 2, 2008
Study Record Updates
Last Update Posted (Actual)
September 7, 2017
Last Update Submitted That Met QC Criteria
September 3, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Parasitic Diseases
- Secernentea Infections
- Nematode Infections
- Helminthiasis
- Rhabditida Infections
- Strongyloidiasis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiprotozoal Agents
- Antiparasitic Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Ivermectin
- Albendazole
Other Study ID Numbers
- TM001-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Strongyloidiasis
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Centro per le Malattie TropicaliEuropean CommissionCompletedStrongyloidiasisItaly, Spain, United Kingdom
-
Jennifer KeiserNational Centre for Parasitology, Entomology and Malaria Control, Cambodia; National Institute of Public Health, Vientiane, LaosEnrolling by invitationStrongyloides Stercoralis InfectionCambodia, Lao People's Democratic Republic
-
Universidad Nacional de SaltaAlbert B. Sabin Vaccine Institute; Fundacion Mundo SanoUnknownHelminthiasis | Strongyloides Stercoralis InfectionArgentina
-
Imperial College Healthcare NHS TrustUnknownStrongyloidiasis | Bone Marrow Transplant Infection
-
IRCCS Sacro Cuore Don Calabria di NegrarCompletedStrongyloides Stercoralis InfectionItaly
-
IRCCS Sacro Cuore Don Calabria di NegrarWorld Health Organization; Universidad Central del Ecuador; CECOMET (Centro de...CompletedStrongyloidiasis | Strongyloides Stercoralis InfectionEcuador
-
Jennifer KeiserNational Centre for Parasitology, Entomology and Malaria Control, CambodiaCompletedStrongyloides Stercoralis InfectionCambodia
-
Albert Einstein College of MedicineTerminatedStrongyloidiasis | Strongyloides Stercoralis InfectionUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infection | Strongyloidiasis | Nematode InfectionUnited States
-
Centers for Disease Control and PreventionUniversidad del Valle, GuatemalaCompletedPediculosis | Strongyloidiasis | Ascariasis | Trichuriasis | Hookworm InfectionGuatemala
Clinical Trials on Albendazole
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Washington University School of MedicineNational Public Health Institute of LiberiaNot yet recruitingOnchocerciasis | Onchocerciasis, Ocular | Tropical Disease | Onchocercal Subcutaneous Nodule | Onchocerca InfectionLiberia
-
London School of Hygiene and Tropical MedicineEmory UniversityTerminated
-
Universidad Nacional de SaltaFundacion Mundo SanoNot yet recruitingPharmacological Action
-
GlaxoSmithKlineCompleted
-
Centers for Disease Control and PreventionUniversidad del Valle, GuatemalaCompletedPediculosis | Strongyloidiasis | Ascariasis | Trichuriasis | Hookworm InfectionGuatemala
-
Navrongo Health Research Centre, GhanaDBL -Institute for Health Research and DevelopmentUnknownAnemia | Malaria | Helminthiasis | Schistosomiasis | Change in Sustained AttentionGhana
-
University GhentSwiss Tropical & Public Health InstituteCompletedSoil-transmitted Helminth InfectionsEthiopia, Lao People's Democratic Republic, Brazil, Tanzania
-
Washington University School of MedicineCompletedLymphatic Filariasis | Onchocerciasis | Soil Transmitted Helminth (STH) InfectionsCôte D'Ivoire
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Swiss Tropical & Public Health InstitutePublic Health Laboratory Ivo de CarneriCompletedTrichuris Trichiura; InfectionTanzania