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Safety and Efficacy of Drug Combinations Against Triple Infections

Primary Purpose

Parasitic Diseases

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
albendazole + ivermectin + praziquantel
albendazole + ivermectin + (1 week later) praziquantel
Sponsored by
DBL -Institute for Health Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parasitic Diseases

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vector Control Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

albendazole + ivermectin + praziquantel

albendazole + ivermectin + (1 week later) praziquantel

Outcomes

Primary Outcome Measures

adverse reactions

Secondary Outcome Measures

Efficacy of treatment

Full Information

First Posted
January 23, 2008
Last Updated
January 14, 2010
Sponsor
DBL -Institute for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01050517
Brief Title
Safety and Efficacy of Drug Combinations Against Triple Infections
Official Title
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
DBL -Institute for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parasitic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
albendazole + ivermectin + praziquantel
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
albendazole + ivermectin + (1 week later) praziquantel
Intervention Type
Drug
Intervention Name(s)
albendazole + ivermectin + praziquantel
Intervention Description
albendazole (400 mg one dose) + ivermectin 200 microgram/kg body weight) + praziquantel (40 mg/kg)
Intervention Type
Drug
Intervention Name(s)
albendazole + ivermectin + (1 week later) praziquantel
Intervention Description
albendazole (400 mg one dose) + ivermectin (200 microgram/kg body weight) + (1 week later) praziquantel (40 mg/kg)
Primary Outcome Measure Information:
Title
adverse reactions
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Efficacy of treatment
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Vector Control Division
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
21353271
Citation
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.
Results Reference
derived

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Safety and Efficacy of Drug Combinations Against Triple Infections

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