Treatment Study of Metronidazole to Treat Dientamoebiasis in Children (DFPT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dientamoebiasis |
Drug: Metronidazole Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metronidazole
Active treatment.
|
Drug: Metronidazole
Metronidazole, oral suspension, 40mg/ml. 1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents. Other Names:
|
|
Placebo Comparator: Placebo
Passive treatment.
|
Drug: Placebo
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. |
Eligibility| Ages Eligible for Study: | 3 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Dennis Röser, MD | +45 32683604 | dsr@ssi.dk |
| Contact: Henrik V Nielsen, Cand scient | +45 32683995 | hvn@ssi.dk |
| Denmark | |
| Statens Serum Institut | Recruiting |
| Copenhagen, Denmark, 2300 | |
| Contact: Dennis Röser, MD +45 32683604 dsr@ssi.dk | |
| Contact: Henrik V Nielsen, Cand scient +45 32683995 hvn@ssi.dk | |
| Principal Investigator: Dennis Röser, MD | |
| Principal Investigator: | Dennis Röser, MD | Statens Serum Institut |
| Study Director: | Dennis Röser, MD | Statens Serum Institut |
More Information
No publications provided
| Responsible Party: | Dennis Roser, MD, PhD fellow, Statens Serum Institut |
| ClinicalTrials.gov Identifier: | NCT01314976 History of Changes |
| Other Study ID Numbers: | DSR-01, 2010-024657-36 |
| Study First Received: | March 14, 2011 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: Ethics Committee |
Keywords provided by Statens Serum Institut:
|
Children parasite intestinal treatment RCT |
Additional relevant MeSH terms:
|
Dientamoebiasis Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Metronidazole |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 22, 2013