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Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

D

DBL -Institute for Health Research and Development

Status

Completed

Conditions

Parasitic Diseases

Treatments

Drug: ivermectin
Drug: albendazole
Drug: albendazole + ivermectin
Drug: mebendazole + ivermectin
Drug: mebendazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01050452
AO.UGA.TRI
DBL-CHRD

Details and patient eligibility

About

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of albendazole (ALB), mebendazole (MBD) and ivermectin (IVM) separately, and ALB and MBD each in combination with IVM in the treatment of Trichuris trichiura in children aged 5-14 years.

Enrollment

750 estimated patients

Sex

All

Ages

5 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Those who are enrolled in class one to six
  • Are infected with T. trichiura
  • Whose parent consent and who are willing to participate

Exclusion criteria

  • Those with acute and chronic diseases other than T. trichiura
  • Those with a history of any serious adverse drug reactions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

750 participants in 5 patient groups, including a placebo group

1
Placebo Comparator group
Description:
albendazole treatment
Treatment:
Drug: albendazole
2
Active Comparator group
Description:
mebendazole treatment
Treatment:
Drug: mebendazole
3
Active Comparator group
Description:
ivermectin treatment
Treatment:
Drug: ivermectin
4
Active Comparator group
Description:
albendazole + ivermectin treatment
Treatment:
Drug: albendazole + ivermectin
5
Active Comparator group
Description:
mebendazole + ivermectin treatment
Treatment:
Drug: mebendazole + ivermectin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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