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
  Purpose

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.


Condition Intervention
Parasitic Diseases
Drug: albendazole + ivermectin + praziquantel
Drug: albendazole + ivermectin + (1 week later) praziquantel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

Primary Outcome Measures:
  • adverse reactions [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
albendazole + ivermectin + praziquantel
Drug: albendazole + ivermectin + praziquantel
albendazole (400 mg one dose) + ivermectin 200 microgram/kg body weight) + praziquantel (40 mg/kg)
Placebo Comparator: 2
albendazole + ivermectin + (1 week later) praziquantel
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)

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050517

Locations
Uganda
Vector Control Division
Kampala, Uganda
Sponsors and Collaborators
DBL -Institute for Health Research and Development
  More Information

No publications provided by DBL -Institute for Health Research and Development

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harriet Namwanje, Vector Control Division, MOH
ClinicalTrials.gov Identifier: NCT01050517     History of Changes
Other Study ID Numbers: AO.UGA.TRIPLE, DBL-CHRD
Study First Received: January 23, 2008
Last Updated: January 14, 2010
Health Authority: Uganda: Ministry of Health

Additional relevant MeSH terms:
Parasitic Diseases
Albendazole
Praziquantel
Ivermectin
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014