Safety and Efficacy of Drug Combinations Against Triple Infections

NCT ID: NCT01050517

Last Updated: 2010-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2007-12-31

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.

Conditions

Parasitic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

albendazole + ivermectin + praziquantel

Group Type: ACTIVE_COMPARATOR

albendazole + ivermectin + praziquantel

Intervention Type: DRUG

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

2

albendazole + ivermectin + (1 week later) praziquantel

Group Type: PLACEBO_COMPARATOR

albendazole + ivermectin + (1 week later) praziquantel

Intervention Type: DRUG

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

Interventions

albendazole + ivermectin + praziquantel

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

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DBL -Institute for Health Research and Development

OTHER

Sponsor Role: lead

Responsible Party

Vector Control Division, MOH

Locations

Vector Control Division

Kampala, , Uganda

Countries

Uganda

References

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.

Reference Type: DERIVED

PMID: 21353271 (View on PubMed)

Other Identifiers

DBL-CHRD

Identifier Type: -

Identifier Source: secondary_id

AO.UGA.TRIPLE

Identifier Type: -

Identifier Source: org_study_id