Metronidazol for the treatment of dientamoebiasis in children in Denmark – A randomized, placebo-controlled, double-blinded clinical trial. - DFPT

Statens Serum Institut0 个研究点目标入组 100 人开始时间: 2011年4月15日最近更新: 2013年7月15日

试验速览

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•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.
•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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•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

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