Treatment Study of Metronidazole to Treat Dientamoebiasis in Children (DFPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis Roser, Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT01314976
First received: March 14, 2011
Last updated: June 25, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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
Study Completion Date: June 2013
Primary Completion Date: May 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:
  • Flagyl® (Metronidazole), oral suspension. Sanofi-aventis
  • ATC-code: P01AB01
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314976

Locations
Denmark
Statens Serum Institut
Copenhagen, Denmark, 2300
Sponsors and Collaborators
Statens Serum Institut
Investigators
Principal Investigator: Dennis Röser, MD Statens Serum Institut
Study Director: Dennis Röser, MD Statens Serum Institut
  More Information

No publications provided by Statens Serum Institut

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: June 25, 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 July 20, 2014