Safety and Efficacy of Drug Combinations Against Schistosomiasis

DBL -Institute for Health Research and Development

Status: Completed

Conditions: Parasitic Diseases

Treatments: Drug: albendazole + praziquantel; Drug: mebendazole + praziquantel

Study type: Interventional

Funder types: Other

Identifiers

NCT01050374

AO.UGA.PZQ

DBL-CHRD

Details and patient eligibility

About

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of MBD in combination with PZQ in the treatment of SCH and STH in children aged 1-15 years of age.

Enrollment: 650 estimated patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Those with an age of 1-15 years of age
• Are infected with schistosomiasis and soil-transmitted helminthiasis
• Whose parent consent and who are willing to participate

Exclusion criteria

• Those with acute and chronic diseases other than schistosomiasis and soil-transmitted helminthiasis
• 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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650 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

albendazole + praziquantel

Treatment:

Drug: albendazole + praziquantel

2

Active Comparator group

Description:

mebendazole + praziquantel

Treatment:

Drug: mebendazole + praziquantel