se of antibiotics in children affected by acute colitis severe
- Conditions
- Acute Severe colitisMedDRA version: 20.1Level: LLTClassification code 10045283Term: UC aggravatedSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-001900-76-IT
- Lead Sponsor
- MBERTO I - POLICLINICO DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 28
-Children between 6 and 18 years with established diagnosis of UC and IBDU using standard criteria (1, 2).
-Admission for IV steroid therapy
-PUCAI of at least 65 points at admission (i.e. severe attack)
-PUCAI>45 at enrolment
-Ability to swallow antibiotics (pills or syrup)
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
-Disease confined to the rectum (Proctitis).
-Antibiotic use for > 3 days in the past 2 weeks, or patients receiving antibiotics at enrollment.
-Any proven infection such as positive stool culture, parasite or C. difficile, urinary tract infection, cellulitis, abscess, pneumonia, line-infections etc.
-Fever >38.5, or >38.0c thought to be unrelated to the inflammatory process of active UC.
-The need for imminent surgery (peritoneal abdominal signs, toxic megacolon (3), massive bleeding etc).
-The probable need for second line medical therapy (infliximab, cyclosoporine,tacrolimus) or colectomy within 5 days of enrolment, as judged by the caring physician.
-Known allergy to more than one antibiotic regimen from the list below.
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