Acute Severe colitis MedDRA version: 20.1 Level: LLT Classification code 10045283 Term: UC aggravated System Organ Class: 100000004856
Conditions
Interventions
Trade Name: AMOXICILLINA MYLAN GENERICS - 5 G/100 ML POLVERE PER SOSPENSIONE ORALE FLACONE 100 ML
Product Name: Amoxicillina
Pharmaceutical Form: Powder and solvent for oral solution
INN or Proposed I
Sponsors
UMBERTO I - POLICLINICO DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim is to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe colitis in an addition to standard corticosteroid therapy, in an open label, investigator-blinded, add-on randomized trial. ;Secondary Objective: - Remission rates (defined by PUCAI<10) without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy, at days 7, separately at discharge, separately at day 14, and separately at 90 days. - Number of patients with PUCAI<35 points at day 5, without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy. - The need for second line therapy by discharge and by 90 days. - Calprotectin levels at 5 and 14 days after treatment. - Change in microbiome pattern. - Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL) at days 5 and 14 after treatment. - Rate of C. difficile infection at days 5 and 14 after treatment.;Primary end point(s): Total PUCAI score at day 5 after treatment (compared between the two treatment groups).;Timepoint(s) of evaluation of this end point: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Remission rates (defined by PUCAI<10) without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy, at days 7, separately at discharge, separately at day 14, and separately at 90 days.; 2. Number of patients with PUCAI<35 points at day 5, without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy; The need for second line therapy by discharge, by 90 days and after 1 year; Rate of steroid-dependency after 1 year of treatment; Calprotectin levels at 0, 5, 14 days, 1, 2, 3, 6 and 12 months after treatment and at discharge; Change in microbiome pattern; Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL) 14 days, 1, 2, 3, 6 and 12 months after treatment; Rate of C. difficile infection 14 days, 1, 2, 3, 6 and 12 months after treatment;Timepoint(s) of evaluation of this end point: 7, 14, 90 days after treatment and at discharge; 5 days after treatment; after 90 days and 1 year after treatment and at discharge; 1 year after treatment; 0, 5, 14 days, 1, 2, 3, 6 and 12 months after treatment and at discharge; 0, 5, 14 days, 1, 2, 3, 6 and 12 months after treatment and at discharge; 14 days, 1, 2, 3, 6 and 12 months after treatment; 14 days, 1, 2, 3, 6 and 12 months after treatment | — |
Countries
Canada, Finland, Israel, Italy, Poland, Romania, Spain
Contacts
Public ContactUOC di Gastroenterologia Pediatrica
Dipartimento di Pediatria "Sapienza" Università di Roma/Azienda Policlinico Umberto I
Outcome results
None listed