Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

NCT01314976 | Completed Phase 4 DMC

• 2 other identifiers: DSR-012010-024657-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dientamoebiasis

Keywords

Children; parasite; intestinal; treatment; RCT

Outcome Measures

Primary Outcomes (1)

• Overall gastrointestinal symptoms, day 14

  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.

  14 days after end of treatment period

Secondary Outcomes (1)

• Realtime PCR for D. fragilis, day 14

  Sample collection 14 days after end of treatment period

Study Arms (2)

Metronidazole

EXPERIMENTAL

Active treatment.

Drug: Metronidazole

Placebo

PLACEBO COMPARATOR

Passive treatment.

Drug: Placebo

Interventions

Metronidazole DRUG

Metronidazole, oral suspension, 40mg/ml. 1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.

Also known as: Flagyl® (Metronidazole), oral suspension. Sanofi-aventis, ATC-code: P01AB01

Metronidazole

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Statens Serum Institut: lead

Study Sites (1)

Statens Serum Institut

Copenhagen, 2300, Denmark

Location

Related Publications (1)

• 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.

  PMID: 24647023 DERIVED

MeSH Terms

Conditions

Dientamoebiasis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dennis Röser, MD

  Statens Serum Institut

  PRINCIPAL INVESTIGATOR

• Dennis Röser, MD

  Statens Serum Institut

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD fellow

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

DK (1)