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Safety and Efficacy of Drug Combinations Against Triple Infections

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ClinicalTrials.gov Identifier: NCT01050517
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : January 15, 2010
Sponsor:
Information provided by:
DBL -Institute for Health Research and Development

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.

Condition or disease Intervention/treatment
Parasitic Diseases Drug: albendazole + ivermectin + praziquantel Drug: albendazole + ivermectin + (1 week later) praziquantel

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections
Study Start Date : October 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. adverse reactions [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Efficacy of treatment [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050517


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

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
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

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