Treatment Study of Metronidazole to Treat Dientamoebiasis in Children
Information source: Statens Serum Institut
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dientamoebiasis
Intervention: Metronidazole (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Statens Serum Institut Official(s) and/or principal investigator(s):
Dennis Röser, MD, Principal Investigator, Affiliation: Statens Serum Institut
Dennis Röser, MD, Study Director, Affiliation: Statens Serum Institut
Overall contact:
Dennis Röser, MD, Phone: +45 32683604, Email: dsr@ssi.dk
Summary
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.
Clinical Details
Official title: Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Overall gastrointestinal symptoms, day 14
Secondary outcome: Realtime PCR for D. fragilis, day 14
Eligibility
Minimum age: 3 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with samples investigated at Statens Serum Institut.
- Faecal sample (index) positive for Dientamoeba fragilis (DF) by realtime PCR, within
< 7 days.
- No faecal samples positive for DF within the period: 3 months prior to and up to
index-sample.
- Telephone interview to parents no later then 14 days after result from index-sample.
- Age 3-12 years old.
- Place of residence: Island of Zealand, incl. capital region.
- Symptoms consistent with gastrointestinal infection of DF: Either 1) ≥ 2 episodes of
diarrhea per week or 2) ≥ 2 episodes of stomach ache per week or 3) ≥ 2 of the
following symptoms: Anorexia, Failure to thrive, Anal itching, excessive flatulence,
other change in bowel movements.
Exclusion Criteria:
- Expected non-compliance.
- Objection to subject participation from referring physician.
- Underlying illness or comorbidity, incl. known gastrointestinal illness (both
infectious and non-infectious), but excluding constipation.
- Known liver disease or intolerance/allergy to metronidazole.
- Positive screening for other intestinal pathogens, which may explain subject
symptoms.
- Treatment with metronidazole outside of study within study period.
- Weight > 50 kg
Locations and Contacts
Dennis Röser, MD, Phone: +45 32683604, Email: dsr@ssi.dk
Statens Serum Institut, Copenhagen 2300, Denmark; Recruiting
Dennis Röser, MD, Phone: +45 32683604, Email: dsr@ssi.dk
Henrik V Nielsen, Cand scient, Phone: +45 32683995, Email: hvn@ssi.dk
Dennis Röser, MD, Principal Investigator
Additional Information
Starting date: July 2011
Last updated: January 29, 2013
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