Kidney Transplant; ComplicationsPhase 3GIPIKNCT05722119
GastroIntestinal Panel in Kidney Transplant Patients
A Phase 3 study testing FilmArray GI in people with Kidney Transplant; Complications and Diarrhoea;Acute, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
This project focuses on the evaluation of the impact of the rapid mutltiplex test on changes in anti-infectious treatments in kidney transplant patients with diarrhea. A higher number of infectious agents detected on the same day of sampling could improve the etiological diagnosis of diarrhea in kidney transplant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Diarrhoea;Acute, Diarrhea Infectious
- What is being tested?
- FilmArray GI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Sep 2024
- Phase
- Phase 3
- 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
- Age ≥ 18 years
- Informed consent
- Patient who received a kidney transplant at least 3 months ago
- Acute diarrhea (at least 3 unformed or liquid stools per day for at least 3 consecutive days or 3 per day and / or weight loss ≥2 kg and / or mucoid and / or bloody stool) or absence of diarrhea for at least a month (asymptomatic non randomized control group)
- Affiliation to social security in accordance with the recommendations of the French law
Who cannot join
- Patients who received an identical HLA transplant from a related donor
- Patients without health insurance
- Patients under guardianship or curatorship
- Pregnant (or breastfeeding) patient
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Impact of the BioFire gastroIntestinal Panel for the Management of Diarrhea in Kidney Transplant Patients
This project focuses on the evaluation of the impact of the rapid mutltiplex test on changes in anti-infectious treatments in kidney transplant patients with diarrhea. A higher number of infectious agents detected on the same day of sampling could improve the etiological diagnosis of diarrhea in kidney transplant patients and optimize therapeutic management.
A prospective study will be conducted to evaluate the impact of a rapid multiplex test with a wide panel of bacteria, viruses and parasites on the clinical management of kidney transplant patients with acute diarrhea. This impact will be evaluated using a control group of kidney transplant patients with acute diarrhea whose infectious diagnosis will be performed by standard methods. The main objective is to determine the impact of the rapid multiplex test on changes in anti-infectious treatments (initiation, change of molecule, total duration of treatment).
- Being tested
- FilmArray GI
- Medical subject headings
- Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray GIDiagnostic test
Also called Multiplex Polymerase Chain Reaction (PCR) assay
Rapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel
| Study group | Role | What they receive |
|---|---|---|
| Multiplex test | Experimental | Multiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea Receives: Diagnostic Test: FilmArray GI |
| Standard of care tests | No intervention | Coproculture with direct examination and Clostridium difficile and A-B toxins search, parasitological examination of the stool and search for enteric viruses (rotavirus, adenovirus, norovirus, astrovirus) in patients with acute diarrhea |
| Control group without diarrhea | Experimental | Multiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients Receives: Diagnostic Test: FilmArray GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of patients with anti-infectious treatment change
Difference in the proportion of patients with an adapation of anti-infectious treatment between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Measured: 1 week
Difference in the time to anti-infectious treatment change
Difference in the time to an adaptation of anti-infectious treatment between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Measured: 1 week
Secondary outcomes (10)
Difference in the proportion of patients with an adaptation of immunosuppressive therapy
Difference in the proportion of patients with an adaptation of immunosuppressive therapy between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Measured: 30 days
Difference in the time to adaptation of immunosuppressive therapy
Difference in the time to adaptation of immunosuppressive therapy between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Measured: 30 days
Proportion of patients with additional tests for the etiological diagnosis of diarrhea
Difference in the proportion of patients with additional tests for the etiological diagnosis of diarrhea between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Measured: 30 days
Number of additional tests for the etiological diagnosis of diarrhea
Difference in the number additional tests for the etiological diagnosis of diarrhea between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Measured: 30 days
Time to digestive endoscopy
Difference in the time to digestive endoscopy between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Measured: 30 days
Duration of diarrhea
Difference in the duration of diarrhea between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Measured: 30 days
Proportion of patients with asymptomatic carriage of infectious agents
Proportion of patients with asymptomatic carriage of infectious agents in the asymptomatic control group
Measured: Day 1
Quantitative polymerase chain reaction (PCR) by multiplex PCR for infectious agents
Quantitative polymerase chain reaction (PCR) by multiplex PCR for infectious agents on a stool sample at baseline
Measured: Day 1
Alpha-diversity
Microbiota alpha-diversity on a stool sample at baseline
Measured: Day 1
Beta-diversity
Microbiota beta-diversity on a stool sample at baseline
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 posted10 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722119
- Sponsor's protocol ID
- APHP211588
- Acronym
- GIPIK
- Status last verified
- Jan 2023
- First submitted
- 1 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of the BioFire gastroIntestinal Panel for the Management of Diarrhea in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT05722119
- Acronym / sponsor ID
- GIPIK / APHP211588
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Feb 2023 (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.
This project focuses on the evaluation of the impact of the rapid mutltiplex test on changes in anti-infectious treatments in kidney transplant patients with diarrhea. A higher number of infectious agents detected on the same day of sampling could improve the etiological diagnosis of diarrhea in kidney transplant patients and optimize therapeutic management.
A prospective study will be conducted to evaluate the impact of a rapid multiplex test with a wide panel of bacteria, viruses and parasites on the clinical management of kidney transplant patients with acute diarrhea. This impact will be evaluated using a control group of kidney transplant patients with acute diarrhea whose infectious diagnosis will be performed by standard methods. The main objective is to determine the impact of the rapid multiplex test on changes in anti-infectious treatments (initiation, change of molecule, total duration of treatment).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiplex test | Experimental | Diagnostic Test: FilmArray GIMultiplex Polymerase Chain Reaction (PCR) assay on stool samples, within 2 hours, in patients with acute diarrhea |
| Standard of care tests | No intervention | –Coproculture with direct examination and Clostridium difficile and A-B toxins search, parasitological examination of the stool and search for enteric viruses (rotavirus, adenovirus, norovirus, astrovirus) in patients with acute diarrhea |
| Control group without diarrhea | Experimental | Diagnostic Test: FilmArray GIMultiplex Polymerase Chain Reaction (PCR) assay on stool samples in asymptomatic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Informed consent
- Patient who received a kidney transplant at least 3 months ago
- Acute diarrhea (at least 3 unformed or liquid stools per day for at least 3 consecutive days or 3 per day and / or weight loss ≥2 kg and / or mucoid and / or bloody stool) or absence of diarrhea for at least a month (asymptomatic non randomized control group)
- Affiliation to social security in accordance with the recommendations of the French law
Key exclusion criteria (4 listed)
- Patients who received an identical HLA transplant from a related donor
- Patients without health insurance
- Patients under guardianship or curatorship
- Pregnant (or breastfeeding) patient
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 GIAlso: Multiplex Polymerase Chain Reaction (PCR) assayRapid multiplex Polymerase Chain Reaction (PCR) assay for digestive infectious agents in stool sample in the baseline diagnostic tests panel | Diagnostic test | Control group without diarrhea, Multiplex test |
Primary outcome
Difference in the proportion of patients with anti-infectious treatment change
Time frame: 1 week
Difference in the proportion of patients with an adapation of anti-infectious treatment between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
Difference in the time to anti-infectious treatment change
Time frame: 1 week
Difference in the time to an adaptation of anti-infectious treatment between the 2 randomized groups (rapid multiplex test group versus standard tests in patients with acute diarrhea)
10 secondary outcomes
Difference in the proportion of patients with an adaptation of immunosuppressive therapy
Time frame: 30 days
Difference in the time to adaptation of immunosuppressive therapy
Time frame: 30 days
Proportion of patients with additional tests for the etiological diagnosis of diarrhea
Time frame: 30 days
Number of additional tests for the etiological diagnosis of diarrhea
Time frame: 30 days
Time to digestive endoscopy
Time frame: 30 days
Duration of diarrhea
Time frame: 30 days
Proportion of patients with asymptomatic carriage of infectious agents
Time frame: Day 1
Quantitative polymerase chain reaction (PCR) by multiplex PCR for infectious agents
Time frame: Day 1
Alpha-diversity
Time frame: Day 1
Beta-diversity
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FilmArray GI in people with Kidney Transplant; Complications and Diarrhoea;Acute, run by Assistance Publique - Hôpitaux de Paris.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Le Goff, MD PhD (+33142499493, jerome.legoff@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportion of patients with anti-infectious treatment change (time frame: 1 week). The study lists 2 primary outcomes in all. 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 22 Feb 2023.