Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04237181 |
| Other study ID # |
APHP191050 |
| Secondary ID |
2019-A02924-53 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 9, 2020 |
| Est. completion date |
December 23, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Statistical justification for sample size: This will be a pilot study to describe the results
of PCT concentration and multiplex GI panel. As to our knowledge, there is no published study
reporting PCT concentrations in this population. This preclude a sample, size calculation.
The investigators will include as much patients as possible during one year in order to cover
the epidemiological seasonal variations and to obtain a convenient sample of at least 100
patients.
Statistical methods description: Clinical and biological data will be reported as median and
interquartile range or mean +/- SD. PCT values will be reported as median and IQR,
respectively if a there is a viral infection, a documented infection (bacterium or parasite)
or no pathogen identified by GI panel and/or stool culture (bacteria). Patient's
characteristics and PCT results will be compared in all groups, using as a reference, the
group where no pathogen is observed. A sub-group analysis will be performed on colitis and
acute diarrhea respectively, to find out if there is any difference with the variables
analyzed as both pathologies are not managed in the same way.
