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Safety and Efficacy of Drug Combinations Against Triple Infections

D

DBL -Institute for Health Research and Development

Status

Completed

Conditions

Parasitic Diseases

Treatments

Drug: albendazole + ivermectin + praziquantel
Drug: albendazole + ivermectin + (1 week later) praziquantel

Study type

Interventional

Funder types

Other

Identifiers

NCT01050517
AO.UGA.TRIPLE
DBL-CHRD

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

250 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
albendazole + ivermectin + praziquantel
Treatment:
Drug: albendazole + ivermectin + praziquantel
2
Placebo Comparator group
Description:
albendazole + ivermectin + (1 week later) praziquantel
Treatment:
Drug: albendazole + ivermectin + (1 week later) praziquantel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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