Safety and Efficacy of Drug Combinations Against Triple Infections
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections
2 other identifiers
interventional
250
1 country
1
Brief Summary
This randomised, controlled, double blinded clinical study investigates the safety and efficacy of the combination of albendazole, ivermectin and praziquantel in the treatment of children aged 5-18 years co-infected with lymphatic filariasis, schistosomiasis and soil-transmitted helminthiasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2010
CompletedJanuary 15, 2010
January 1, 2010
2 months
January 23, 2008
January 14, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
adverse reactions
6 weeks
Secondary Outcomes (1)
Efficacy of treatment
6 weeks
Study Arms (2)
1
ACTIVE COMPARATORalbendazole + ivermectin + praziquantel
2
PLACEBO COMPARATORalbendazole + ivermectin + (1 week later) praziquantel
Interventions
albendazole (400 mg one dose) + ivermectin 200 microgram/kg body weight) + praziquantel (40 mg/kg)
albendazole (400 mg one dose) + ivermectin (200 microgram/kg body weight) + (1 week later) praziquantel (40 mg/kg)
Eligibility Criteria
You may qualify if:
- Those who will be in class one to six by the time of study
- Aged 5-18 years and found infected with either SCH, any STH or LF for treatment groups 1,2 or 3 or infected with both SCH and LF for treatment group 4 and infected with all the three for treatment group 5
- Who are willing and consent and whose parents will consent, will be included in the study.
You may not qualify if:
- Those with acute and chronic diseases other than the targeted infections and those with a history of any serious adverse drug reactions will not be included in the study.
- Children with total bilirubin \> 50µmol/L and ALAT (Alanine transferase) \> 70IU/L will not qualify for recruitment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vector Control Division
Kampala, Uganda
Related Publications (1)
Namwanje H, Kabatereine N, Olsen A. A randomised controlled clinical trial on the safety of co-administration of albendazole, ivermectin and praziquantel in infected schoolchildren in Uganda. Trans R Soc Trop Med Hyg. 2011 Apr;105(4):181-8. doi: 10.1016/j.trstmh.2010.11.012. Epub 2011 Feb 25.
PMID: 21353271DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 23, 2008
First Posted
January 15, 2010
Study Start
October 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
January 15, 2010
Record last verified: 2010-01