Safety and Efficacy of Drug Combinations Against Trichuris Trichiura

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

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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