Clinical trial NCT01314976: Treatment Study of Metronidazole to Treat Dientamoebiasis in Children
Official title: Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dientamoebiasis
Keywords: Children
parasite
intestinal
treatment
RCT
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Overall gastrointestinal symptoms, day 14
timeFrame: 14 days after end of treatment period
Secondary outcomes:
measure: Realtime PCR for D. fragilis, day 14
timeFrame: Sample collection 14 days after end of treatment period
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Statens Serum Institut
Study officials:
affiliation: Statens Serum Institut
name: Dennis Röser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Statens Serum Institut
name: Dennis Röser, MD
role: STUDY_DIRECTOR
References:
citation: Roser D, Simonsen J, Stensvold CR, Olsen KE, Bytzer P, Nielsen HV, Molbak K. Metronidazole therapy for treating dientamoebiasis in children is not associated with better clinical outcomes: a randomized, double-blinded and placebo-controlled clinical trial. Clin Infect Dis. 2014 Jun;58(12):1692-9. doi: 10.1093/cid/ciu188. Epub 2014 Mar 18.