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Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

NCT01314976 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-06-26

No results posted yet for this study

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

Interventions

DRUG

Metronidazole

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

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.

Sponsors & Collaborators

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Dennis Röser, MD · Statens Serum Institut

  • Dennis Röser, MD · Statens Serum Institut

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01314976 on ClinicalTrials.gov