Acute DiarrheaPRODIARRAYNCT04237181
Results of FilmArray® Gastro-intestinal Panel and Serum Procalcitonin in Acute Colitis and Infectious Diarrhea in the ER
A study testing Filmarray PCR multiplex-PCT assay in people with Acute Diarrhea and Acute Colitis of Presumed Infectious Origin, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Diarrhea, Acute Colitis of Presumed Infectious Origin
- What is being tested?
- Filmarray PCR multiplex-PCT assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2020to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria for patients presenting an acute diarrhoea :
- 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
Show all 14Show fewer
- Inclusion criteria for patients presenting an infectious colitis :
- 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.
Who cannot join
- Recent abdominal surgery of less than one month
- Pregnancy
- Inflammatory bowel disease
- Patients under curatorship or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of FilmArray® Gastro-intestinal Panel (GI Panel) and Serum Procalcitonin (PCT) in Acute Colitis and Infectious Diarrhea in the Emergency Department.
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.
Read more
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.
Read the detailed 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.
- Being tested
- Filmarray PCR multiplex-PCT assay
- Keywords
- Infectious Diarrhea, Colitis, PCR multiplex, PCT
- Medical subject headings
- Dysentery, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filmarray PCR multiplex-PCT assayDevice
Filmarray PCR multiplex gastro intestinal panel on stools and serum PCT dosage
| Study group | Role | What they receive |
|---|---|---|
| Acute diarrhoea or colitis presumed to be of infectious origin | Other | Not described Receives: Device: Filmarray PCR multiplex-PCT assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (4)
Positivity rate and distribution of pathogens identified by the GI panel and stool culture
Positivity Rate of GI Panel and stool culture given in percentage (%) and the distribution of pathogens found if positive, divided in 3 groups (virus, bacteria and parasites)
Measured: Day 1
Rate of antibiotic therapy initiated in the ER and in the first following 15 days
Rate of antibiotics use given in percentage (%)
Measured: Day 1 and 15
Number of days of antibiotic exposure at day 15
Number of days on antibiotics for each patient
Measured: Day 15
Rate of antibiotics prescription before and after results of the GI panel and PCT (Day 1)
Rate (%) of intention to start an antibiotic before the results of the GI panel and rate (%) of antibiotic's prescription after the results of the GI panel and PCT
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start9 Mar 2020
- Primary completion24 Mar 2020
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiarrheaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237181
- Sponsor's protocol ID
- APHP191050
- Other IDs
- 2019-A02924-53
- Acronym
- PRODIARRAY
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of FilmArray® Gastro-intestinal Panel (GI Panel) and Serum Procalcitonin (PCT) in Acute Colitis and Infectious Diarrhea in the Emergency Department.
- ClinicalTrials.gov ID
- NCT04237181
- Acronym / sponsor ID
- PRODIARRAY / APHP191050
- Keywords
- Infectious Diarrhea, Colitis, PCR multiplex, PCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute diarrhoea or colitis presumed to be of infectious origin | Other | Device: Filmarray PCR multiplex-PCT assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- Recent abdominal surgery of less than one month
- Pregnancy
- Inflammatory bowel disease
- Patients under curatorship or guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filmarray PCR multiplex-PCT assayFilmarray PCR multiplex gastro intestinal panel on stools and serum PCT dosage | Device | Acute diarrhoea or colitis presumed to be of infectious origin |
Primary outcome
PCT concentration according to each type of pathogens identified using GI panel and stool cultures (bacteria, virus, parasites).
Time frame: Day 1
The median PCT concentration will be reported in the three main etiological group (viruses, bacteria, parasites) identified by stool culture and GI panel
4 secondary outcomes
Positivity rate and distribution of pathogens identified by the GI panel and stool culture
Time frame: Day 1
Rate of antibiotic therapy initiated in the ER and in the first following 15 days
Time frame: Day 1 and 15
Number of days of antibiotic exposure at day 15
Time frame: Day 15
Rate of antibiotics prescription before and after results of the GI panel and PCT (Day 1)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filmarray PCR multiplex-PCT assay in people with Acute Diarrhea and Acute Colitis of Presumed Infectious Origin, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCT concentration according to each type of pathogens identified using GI panel and stool cultures (bacteria, virus, parasites). (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.