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Rectal Metronidazole vs Oral Tinidazole for Pediatric Giardiasis
NCT02942485Phase 4
Key facts
- Status
- Terminated
- Start
- Dec 2016
- Primary completion
- Dec 2019
- Countries
- 1
- Sponsor
- Helsinki University Hospital
- Modality
- Small Molecules
- Drugs
- metronidazole
- Conditions
- giardiasis
01
Overview
Phase 4, randomised, open-label trial of metronidazole in giardiasis (2 arms), sponsored by Helsinki University Hospital. Primary endpoint: Clinical Recovery at 10 days. Started Dec 2016; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Rectal Metronidazole
Rectal metronidazole suppositories once daily for 3 days
Oral Tinidazole
Single dose of oral tinidazole
03
Who it enrols
Children aged 6 months to 10 years with symptomatic Giardia lamblia infection confirmed by positive fecal antigen test, weighing at least 9.5 kg, and without co-infections.
04
Endpoints
Primary
Clinical Recovery
Secondary
Number of Participants With Side-effects
Number of Participants With Negative G.Lamblia Antigen Test
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