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

January 23, 2008
January 14, 2010
October 2007
December 2007   (final data collection date for primary outcome measure)
adverse reactions [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01050517 on ClinicalTrials.gov Archive Site
Efficacy of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Drug Combinations Against Triple Infections
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parasitic Diseases
  • 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)
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01050517
AO.UGA.TRIPLE, DBL-CHRD
No
Harriet Namwanje, Vector Control Division, MOH
DBL -Institute for Health Research and Development
Not Provided
Not Provided
DBL -Institute for Health Research and Development
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP