Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall gastrointestinal symptoms, day 14
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Metronidazole
Active treatment.
干预措施: Metronidazole (Drug)
Placebo
Passive treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall gastrointestinal symptoms, day 14
时间窗: 14 days after end of treatment period
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.
次要结局
- Realtime PCR for D. fragilis, day 14(Sample collection 14 days after end of treatment period)
研究者
Dennis Roser
MD, PhD fellow
Statens Serum Institut