Safety and Efficacy of Drug Combinations Against Triple Infections

Parasitic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050517
• Other study ID #: AO.UGA.TRIPLE
• Secondary ID: DBL-CHRD
• Status: Completed
• Phase: N/A
• First received: January 23, 2008
• Last updated: January 14, 2010
• Start date: October 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2010
• Source: DBL -Institute for Health Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasitic Diseases

Intervention

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

Locations

Country	Name	City	State
Uganda	Vector Control Division	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
DBL -Institute for Health Research and Development

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse reactions		6 weeks	Yes
Secondary	Efficacy of treatment		6 weeks	No