Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

Not Applicable

Completed

• Conditions: Parasitic Diseases
• Interventions: Drug: albendazole; Drug: mebendazole; Drug: ivermectin; Drug: albendazole + ivermectin; Drug: mebendazole + ivermectin

• Registration Number: NCT01050452
• Lead Sponsor: DBL -Institute for Health Research and Development

Brief Summary

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-22
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-01
• Study First Submitted QC: 2010-01-14
• Last Update Submitted: 2010-01-14
• Study First Posted: 2010-01-15
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Those who are enrolled in class one to six
• Are infected with T. trichiura
• Whose parent consent and who are willing to participate

Exclusion Criteria

• Those with acute and chronic diseases other than T. trichiura
• Those with a history of any serious adverse drug reactions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	albendazole	albendazole treatment
2	mebendazole	mebendazole treatment
3	ivermectin	ivermectin treatment
4	albendazole + ivermectin	albendazole + ivermectin treatment
5	mebendazole + ivermectin	mebendazole + ivermectin treatment

Primary Outcome Measures

Name	Time	Method
Record adverse reactions	6 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy of treatment	6 weeks

Trial Locations

Locations (1)

Vector Control Division; 🇺🇬 Kampala, Uganda