Pediatric Acute Severe Colitis Clinical Trial
Official title:
Managing Pediatric Acute Severe Colitis According to the 2011 ECCO-ESPGHAN Guidelines: Efficacy of Infliximab as a Rescue Therapy
| Verified date | June 2014 |
| Source | University of Roma La Sapienza |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Observational |
Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening
event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a
second line therapy. This study was performed in consecutively observed pediatric patients
with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)-
European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN)
guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical
predictors of poor outcome.
Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative
Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment
through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein,
hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All
patients were treated according to the above mentioned guidelines for ASC and received
intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as
second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy
rate and the efficacy of IFX in avoiding colectomy were evaluated.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 18 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of ASC - Confirmed diagnosis of ulcerative colitis (UC) - Age 1-18 years Exclusion Criteria: - Not confirmed diagnosis of UC - Contraindications for infliximab therapy |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Department of Pediatrics, Sapienza University of Rome | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| University of Roma La Sapienza |
Italy,
Turner D, Griffiths AM. Acute severe ulcerative colitis in children: a systematic review. Inflamm Bowel Dis. 2011 Jan;17(1):440-9. doi: 10.1002/ibd.21383. Review. — View Citation
Turner D, Mack D, Leleiko N, Walters TD, Uusoue K, Leach ST, Day AS, Crandall W, Silverberg MS, Markowitz J, Otley AR, Keljo D, Mamula P, Kugathasan S, Hyams J, Griffiths AM. Severe pediatric ulcerative colitis: a prospective multicenter study of outcomes and predictors of response. Gastroenterology. 2010 Jun;138(7):2282-91. doi: 10.1053/j.gastro.2010.02.047. Epub 2010 Feb 26. — View Citation
Turner D, Travis SP, Griffiths AM, Ruemmele FM, Levine A, Benchimol EI, Dubinsky M, Alex G, Baldassano RN, Langer JC, Shamberger R, Hyams JS, Cucchiara S, Bousvaros A, Escher JC, Markowitz J, Wilson DC, van Assche G, Russell RK; European Crohn's and Colitis Organization; Porto IBD Working Group, European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Consensus for managing acute severe ulcerative colitis in children: a systematic review and joint statement from ECCO, ESPGHAN, and the Porto IBD Working Group of ESPGHAN. Am J Gastroenterol. 2011 Apr;106(4):574-88. doi: 10.1038/ajg.2010.481. Epub 2011 Jan 11. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The number of patients with ASC treated with IFX requiring colectomy | The surgical need will be evaluated in the group of patients treated with IFX during a 24-month follow-up | 24 months | No |
| Secondary | The number of patients with ASC requiring colectomy | 1,6,12,18,24 months | No | |
| Secondary | To identify clinical predictive factors at the diagnosis of ASC of surgical need at follow-up | Clinical variables at the diagnosis of ASC (i.e. duration of the disease before the episode of SC, past and ongoing therapies, age, family history, Perinuclear Anti-Neutrophil Cytoplasmic Antibodies - pANCA, PUCAI) were evaluated in the group of children needed colectomy at follow-up versus those not requiring surgery. | First day of the hospitalization | No |