Safety and Efficacy of Drug Combinations Against Triple Infections

This study has been completed.

Sponsor:

Information provided by:

DBL -Institute for Health Research and Development

ClinicalTrials.gov Identifier:

NCT01050517

First received: January 23, 2008

Last updated: January 14, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 23, 2008
Last Updated Date	January 14, 2010
Start Date ^ICMJE	October 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 14, 2010)	adverse reactions [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01050517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 14, 2010)	Efficacy of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Drug Combinations Against Triple Infections
Official Title ^ICMJE	Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Parasitic Diseases
Intervention ^ICMJE	Drug: albendazole + ivermectin + praziquantel albendazole (400 mg one dose) + ivermectin 200 microgram/kg body weight) + praziquantel (40 mg/kg) Drug: albendazole + ivermectin + (1 week later) praziquantel albendazole (400 mg one dose) + ivermectin (200 microgram/kg body weight) + (1 week later) praziquantel (40 mg/kg)
Study Arm (s)	Active Comparator: 1 albendazole + ivermectin + praziquantel Intervention: Drug: albendazole + ivermectin + praziquantel Placebo Comparator: 2 albendazole + ivermectin + (1 week later) praziquantel Intervention: Drug: albendazole + ivermectin + (1 week later) praziquantel
Publications *	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. Epub 2011 Feb 25.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	250
Completion Date	December 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	5 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Uganda

Administrative Information
NCT Number ^ICMJE	NCT01050517
Other Study ID Numbers ^ICMJE	AO.UGA.TRIPLE, DBL-CHRD
Has Data Monitoring Committee	No
Responsible Party	Harriet Namwanje, Vector Control Division, MOH
Study Sponsor ^ICMJE	DBL -Institute for Health Research and Development
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	DBL -Institute for Health Research and Development
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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