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Determination of the Aetiologies of Acute Colitis and Early Identification of Patients Requiring Diagnostic Colonoscopy

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ClinicalTrials.gov Identifier: NCT02709213
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
BioMérieux
Information provided by (Responsible Party):
Jeremy Meyer, University Hospital, Geneva

Brief Summary:
The aetiologies of computed tomography-diagnosed acute colitis remain surprisingly unknown. Moreover, no diagnostic tool or clinical score allow to quickly determine or at least stratify the exact cause of colitis in patients admitted at an Emergency Ward and to direct them to the appropriate therapeutic care. The aims of the present study are to describe the presentation and aetiologies of acute colitis, and to develop diagnostic methods to guide patients admitted for acute colitis to the appropriate therapeutic care, notably colonoscopy.

Condition or disease Intervention/treatment
Colitis Diagnostic Test: Diagnostic

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Colitis Prospective Cohort Study: Determining the Aetiologies of Acute Colitis and Developing a Diagnostic Score to Identify Patients Requiring Specific Investigations
Study Start Date : November 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with CT-diagnosed acute colitis
Patients with symptomatic colitis (fever and/or pain and/or diarrhea) proven by computed tomography
Diagnostic Test: Diagnostic
Determination of pathogens and faecal calprotectin in the stools
Other Names:
  • Stools: Faecal calprotectin
  • Stools: FilmArray GI panel (PCR multi-array)




Primary Outcome Measures :
  1. Determination of the aetiologies of colitis using microbiological examination of the stools +/- colonoscopy [ Time Frame: <24 hours ]
    Determination of the aetiologies of colitis and classification into one of the following categories (in %): infectious colitis (bacterial, parasitic or viral), chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease, other), ischemic colitis and iatrogenic colitis (non-steroidal anti-inflammatory drugs, other). In first intention, the routine microbiological examination of the stools usually performed (PCR assay looking for Shigella spp., Salmonella spp. and Campylobacter spp.; PCR for Clostridium difficile as well as cultures for Vibrio spp. and Yersinia spp. (in option)) will be completed with a high-sensitivity multi-array PCR assay (FilmArray). If the routine microbiological examination of the stools yields to the absence of a potential pathogen, a colonoscopy will be performed to look for: 1) a tumour, 2) a chronic inflammatory bowel disease, or 3) an ischaemic colitis. Patients in whom no aetiology can be found will be given a diagnosis of indeterminate colitis.


Secondary Outcome Measures :
  1. Identification of anamnestic, clinical and biological predicting factors for patients requiring diagnostic colonoscopy [ Time Frame: <24 hours and at 1 year ]
    Variables related to patients presentation at admission will be detailed and collected, regarding anamnesis, clinical examination and para-clinical exams. Results of the investigations performed during hospitalization will be collected (microbiological examination of the stools, colonoscopy). Faecal calprotectin will be determined for all stool samples. The Geneva Tumour Registry will be searched for the occurrence of tumour at the site of colitis at 1 year after the initial diagnosis. Predictors of "positive" colonoscopy (inflammatory bowel disease, cancer) will be identified using univariate and multivariate logistic regression, analysing variables collected at admission and faecal calprotectin.


Biospecimen Retention:   Samples Without DNA
Stools


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients admitted at the Emergency Department with a first diagnosis of computed tomography-diagnosed acute colitis
Criteria

Inclusion Criteria:

  • ≥18 year old
  • French speaking
  • Informed consent
  • ≥1 symptom compatible with an acute colitis (fever≥38°C ± acute abdominal pain ± diarrhoea) + colon wall thickening at computed tomography

Exclusion Criteria:

  • Another diagnostic evoked by the radiologist (diverticulitis, tumor, ...)
  • Patient with a positive history for: chronic inflammatory bowel disease ± colorectal cancer ± immunosuppression ± abdominal ascites
  • Colonoscopy ≤1 year
  • Refusal of investigations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709213


Contacts
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Contact: Jeremy Meyer, MD-PhD +41795533182 jeremy.meyer@hcuge.ch
Contact: Frédéric Ris, MD, PD frederic.ris@hcuge.ch

Locations
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Switzerland
University Hospitals of Geneva Recruiting
Geneva, Switzerland
Contact: Jeremy Meyer, MD-PhD    +41795533182    jeremy.meyer@hcuge.ch   
Contact: Frédéric Ris, MD, PD       frederic.ris@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
BioMérieux
Investigators
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Principal Investigator: Jeremy Meyer, MD-PhD University Hospitals of Geneva, Switzerland

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Responsible Party: Jeremy Meyer, MD-PhD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02709213     History of Changes
Other Study ID Numbers: 14-211
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeremy Meyer, University Hospital, Geneva:
Inflammatory chronic bowel disease
ICBD
Colorectal cancer
Infectious colitis

Additional relevant MeSH terms:
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Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases