Enterovirus- and parechovirus infection in Dutch children: epidemiology, diagnosis and prognosis

Recruiting

Conditions: Enterovirus infection
common viral infection of the digestive system
10047438

Registration Number: NL-OMON31728

Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

A + B are required;A. All Children <= 16 years of age with a clinical suspicion of an EV/HPeV infection:
1. Fever (temperature >=38,0°C )
2. Meningeal inflammation: (anamnestic or with examination at least 2 of the following: headache, photophobia, nuchal rigidity, irritability, lethargy, nausea, vomiting, drowsiness, positive sign of Kernig or Brudzinsky) OR
3. At least 3 of the following: hypothermia, headache, drowsiness, nuchal rigidity, irritability, photofobia, vomiting, diarrhea, anorexia, couhing, myalgia, rash OR
4. Sepsis: Clinical suspicion of an infection plus:
- temperature >38,5°C of < 36°C rectal or oral
- tachycardia: heart rate > 2 SD for age OR children < 1 year with a bradycardia: heart rate < 2 SD for age
- tachypnea: breathing rate> 2 SD for age ;B. Signed informed consent by the parent(s)/legal guardian(s)

Exclusion Criteria

- Other proven cause of the infection: positive bacterial, viral (other than EV/HPeV), parasitic or fungal/yeast culture or PCR (feces, urine, throat swab, blood, CSF).
- Other causes of illness: neoplasma, auto-immune diseases, rheumatic diseases, endocrinologic diseases, gastrooesophageal reflux, etcetera
- Known psycho-motor retardation, metabolic diseases with neuro-muscular or cognitive abnormalities
- Patients older than 16 years of age
- No signed informed consent from the parent(s)/ legal Guardian(s)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Specific clinical symptoms in patients with proven EV or HPeV infection<br /><br>- Different laboratory diagnostic methods: viral culture, PCR and serology<br /><br>- Several body fluids: feces, urine, throat swab, blood, and eventually CSF<br /><br>- Developmental milestones of children after an EV/HPeV CNS infection </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Morbidity due to EV/HPeV infection (hospitalization, duration of<br /><br>hospitalization, duration and severity of symptoms, average school- and work<br /><br>absence, duration use of antibiotics)<br /><br>- Antibiotic treatment of patients (antibiotics, stop of antibiotics after<br /><br>diagnosis of EV or HPeV infection)</p><br>