Treatment Study of Metronidazole to Treat Dientamoebiasis in Children (DFPT)
Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is considered a possible cause of infectious gastrointestinal disease in adults and children. DF has a particular high prevalence in children, and it is suspected that children present more symptoms in infection than adults. However, evidence of causality is lacking, treatment regimens are largely untested in controlled trials, and the most commonly used antibiotic against DF in Denmark, metronidazole, has never been tested against placebo.
Main objective: To determine the clinical effect of metronidazole in DF-infected children with gastrointestinal complaints, where no other aetiology is known and no other gastrointestinal pathogens could be shown.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial|
- Overall gastrointestinal symptoms, day 14 [ Time Frame: 14 days after end of treatment period ] [ Designated as safety issue: No ]
All participants receive 10 days of treatment with study drug (placebo or active). Primary outcome measure is registered on day 14 after end of treatment, using a questionnaire for the parents of the study participant.
Measuring will be done using a VAS-score scale, addressing overall level of gastrointestinal symptoms in the previous 14 days. Results will be noted as a value from 0 to 10.
- Realtime PCR for D. fragilis, day 14 [ Time Frame: Sample collection 14 days after end of treatment period ] [ Designated as safety issue: No ]
Secondary outcome measure will be registered using a specific realtime PCR for D. fragilis, performed on faecal samples collected from study-participant.
Results will be noted as either positive or negative.
|Study Start Date:||July 2011|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Metronidazole, oral suspension, 40mg/ml.
1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.
Placebo Comparator: Placebo
1 treatment period of 1ml/kg/day for 10 days, 3 daily dosages. Administered by parents.
Placebo formulation is identical to Flagyl® (Metronidazole), oral suspension from Sanofi-Aventis.
|Statens Serum Institut|
|Copenhagen, Denmark, 2300|
|Principal Investigator:||Dennis Röser, MD||Statens Serum Institut|
|Study Director:||Dennis Röser, MD||Statens Serum Institut|