Safety and efficacy of rectally administered metronidazole for the treatment of Giardia lamblia infections in childre

Phase 1

• Conditions: Symptomatic Giardia lamblia infections in children; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2016-001938-96-FI
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-28
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Children aged 6 months to 10 years whose clinical symptoms could be explained by giardiasis and whose fecal samples will test positive for the presence of Giardia lamblia in Uusimaa laboratory (HUSLAB).
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) age <6 mo or >10 years, 2) weight <9.5 kg, 3) the absence of symptoms, 4) co-infection with another pathogen, which may cause giardiasis-like symptoms.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified