Effectiveness on the clinical outcome of an oral enterovaccine (Colifagina) and evaluation of the role of the Astrovirus in the aetiology of the pathology of acute gastroenteritis in children.? - ND
- Conditions
- acute gastroenteritis in children.?MedDRA version: 9.1Level: LLTClassification code 10017893Term: Gastroenteritis astroviral
- Registration Number
- EUCTR2008-001342-13-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patients aged >2 and <10 years old
Intestine symptoms have been present for at least 24 hours and for less than 3 weeks: diarrhoea (al least 2 evacuations/day) and/or vomit.
Fever (TC = o > 37.5C).
Informed consent to study given by parents
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients suffering from a present or past neoplastic condition, with chronic renal insufficiency and/or hepatic insufficiency or severe cardiovascular and/or neurological and/or gastrointestinal pathology.
Patients with congenital deficit of IgA and/or with congenital immuno-deficiency
Patients receiving immunosuppressive therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method