REALISE: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness

Phase 3

• Conditions: Paediatrics; Soil-transmitted helminths

• Registration Number: PACTR202402529220760
• Lead Sponsor: aboratorios Liconsa SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-05
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

Age: 5 to 17 years old (included).
- Height: over 90cm.
- Parental acceptance to participate in the study by obtaining written informed consent approved by the Ethics Committee. Written assent will also be obtained from children according to the local national legislation. (In Kenya written assent will be obtained from children 12-17 years old and in Ghana for children 15-17 years old.)

Exclusion Criteria

- Epidemiological risk of being infected by Loa loa.
- Serious medical illness, per investigator’s criteria.
- Any condition prevents the appropriate evaluation and follow-up of the participant, per the investigator’s criteria.
- Known hypersensitivity to any component of either study treatment.
- Pregnant or first week post-partum, reported by the participant during interview.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency, type and severity of related AEs and SAEs for FDC and ALB

Secondary Outcome Measures

Name	Time	Method
Reduction in T. trichiura prevalence determined by microscopy for FDC and ALB.