Results of FilmArray® Gastro-intestinal Panel and Serum Procalcitonin in Acute Colitis and Infectious Diarrhea in the ER

NCT04237181 | Completed

• 2 other identifiers: APHP1910502019-A02924-53
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Acute diarrhea and acute colitis of infectious origin are common reasons for consultation at the emergency department. The current etiological diagnostic approach is limited to the determination of markers of inflammation, such as CRP and blood leukocytes, which lack specificity and sensitivity for bacterial infection. The stool culture can detect bacterial pathogens in the stool with a result at least 48 hours later and a positivity rate \<50%. This study will describe the procalcitonin (PCT) concentrations (a biomarker of bacterial infection) in this population to evaluate its usefulness depending on the viral or bacterial etiology identified by stool multiplex gastro-intestinal PCR panel (GI panel) and stool culture. The investigators hypothesize that PCT levels will be higher if the GI panel or the stool culture identifies a bacteria or a parasite, as it is the case in respiratory tract infections. If there is a detection of a virus by the GI panel or both the stool culture and the GI panel are negative, the investigators expect that PCT values will be lower or negative. the investigators will include the patients admitted to the ED with a suspicion of infectious diarrhea or acute colitis in order to have a large representative panel of infectious diarrhea etiologies. Only the patients having a blood sample prescribed as the routine care will be included. The blood sample is useful for dosing CRP and whole blood cell count (WBC), which are part of current biologic analyses performed in this context. After getting the patient's consent, the investigator will add the PCT dosage in blood sampling and will ask the patient to provide a stool sample, in order to have a stool culture and to perform an extended investigation for the pathogens through multiplex PCR technology (Filmarray ®GI panel). The physician will be asked if all these results (the ones ordered currently together with the dosage of PCT and the GI panel) will change his/her decision to start an antibiotic. Patients will receive a phone call at day 15 after their initial admission in the emergency department and will be asked if he/she has consulted a new physician or if a new treatment by antibiotics was started. Data collection procedures: Data from the medical file will be collected by the investigators and the emergency department clinical research assistant. All the data will be pseudonymized. The collection will be done at the day of admission in the emergency department and after the phone interview at Day15.

Conditions

Acute Diarrhea; Acute Colitis of Presumed Infectious Origin

Keywords

Infectious Diarrhea; Colitis; PCR multiplex; PCT

Outcome Measures

Primary Outcomes (1)

• PCT concentration according to each type of pathogens identified using GI panel and stool cultures (bacteria, virus, parasites).

  The median PCT concentration will be reported in the three main etiological group (viruses, bacteria, parasites) identified by stool culture and GI panel

  Day 1

Secondary Outcomes (4)

• Positivity rate and distribution of pathogens identified by the GI panel and stool culture

  Day 1

• Rate of antibiotic therapy initiated in the ER and in the first following 15 days

  Day 1 and 15

• Number of days of antibiotic exposure at day 15

  Day 15

• Rate of antibiotics prescription before and after results of the GI panel and PCT (Day 1)

  Day 1

Study Arms (1)

Acute diarrhoea or colitis presumed to be of infectious origin

OTHER

Device: Filmarray PCR multiplex-PCT assay

Interventions

Filmarray PCR multiplex-PCT assay DEVICE

Filmarray PCR multiplex gastro intestinal panel on stools and serum PCT dosage

Acute diarrhoea or colitis presumed to be of infectious origin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age,
• Signed informed consent form
• Having a social security insurance,
• Attending the emergency department for Acute diarrhoea (at least three loose or liquid stools a day for less than 15 days)
• For whom a blood test in the emergency department is ordered as a standard of care
• Patients over 18 years of age,
• Signed informed consent form
• Having a social security insurance,
• Attending the emergency department for a documented colitis presumed to be of infectious origin, for whom a blood test in the emergency department is planned, defined by:
• at least one of the following symptoms: abdominal pain, fever, diarrhoea and
• Elevated white blood cell count (\> 10.000/mm3) or CRP (\> 10 mg/l) and
• An abdominal CT scan showing a thickening of at least segmental colonic walls.

You may not qualify if:

• Recent abdominal surgery of less than one month
• Pregnancy
• Inflammatory bowel disease
• Patients under curatorship or guardianship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Biofire: collaborator

Study Sites (1)

Pitié Salpetriere

Paris, 75012, France

Location

MeSH Terms

Conditions

Dysentery; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: March 9, 2020
• Primary Completion: March 24, 2020
• Study Completion: December 23, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)