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Completed

NCT Number: NCT01050517

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.

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Key information

Conditions

Parasitic Diseases Infections

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vector Control Division

Kampala, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

albendazole + ivermectin + praziquantel

Drug

albendazole (400 mg one dose) + ivermectin 200 microgram/kg body weight) + praziquantel (40 mg/kg)

albendazole + ivermectin + (1 week later) praziquantel

Drug

albendazole (400 mg one dose) + ivermectin (200 microgram/kg body weight) + (1 week later) praziquantel (40 mg/kg)

Primary outcomes

  1. adverse reactions

    Time frame: 6 weeks

Secondary outcomes

  1. Efficacy of treatment

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

DBL -Institute for Health Research and Development

Other

Registry information

Official study title

Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 15, 2010
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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