InfectionARIIBACTNCT03948308
Alteration of the Immune Response in Bacterial Infection
A study testing blood sample in people with Infection, run by Versailles Hospital at 1 site in France.
Trial summary
The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Infection
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 1 Sep 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years
- BMI 18 to 25
- presence of a bacterial infection
- pneumopathy (documented or probable)
- acute pyelonephritis / prostatitis
- skin and soft tissue infection (erysipelas, fasciitis, excluding pressure ulcers)
Show all 9Show fewer
- cholecystitis / cholangitis,
- surgical site infection
- signed informed consent
Who cannot join
- patients with documented viral, parasitic or mycotic infections
- patients with bacterial infection> 4 weeks (eg endocarditis, osteoarticular infections)
- patients followed in intensive unit care
- patients with progressive cancerous pathology or malignant hemopathy diagnosed in the previous five years
- patients with systemic diseases (connective tissue diseases, vasculitis)
- known immunodepression syndrome (CVID, HIV ...)
- immunosuppressive therapy in progress until less than one month before inclusion (corticosteroids, DMARDs, biotherapies, hydroxychloroquine)
Trial locations and contacts
1 site in 1 country.
About this study
The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects.
In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile.
It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"
- Conditions
- Infection
- Being tested
- blood sample
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
blood sample before, during and after infection treatment
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | blood sample before, during and after treatment for infection Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
Description of an immunological profile of inflammation using current inflammatory cytokines during sepsis in non-obese subjects in comparison with this same profile in obese subjects
Measured: 1 month
adipokin analysis (leptine, adiponectine)
Description of the kinetics of 2 cytokines more speficically involved in obesity (leptine, adipokinine) during sepsis in non-obese subjects in comparison with this same profile in obese subjects
Measured: 1 month
leptin polymorphism analysis
Description of the genetic polymorphism of leptine and leptine receptor in non-obese subjects in comparison with this same profile in obese subjects
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 May 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roderick Meckenstock, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948308
- Sponsor's protocol ID
- P17/03_ARIIBACT
- Acronym
- ARIIBACT
- Status last verified
- May 2019
- First submitted
- 15 Apr 2019
- Last updated
- 13 May 2019
- 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 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of the Immune Response in Bacterial Infection
- ClinicalTrials.gov ID
- NCT03948308
- Acronym / sponsor ID
- ARIIBACT / P17/03_ARIIBACT
- Conditions
- Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 13 May 2019 (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.
The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects.
In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile.
It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Biological: blood sampleblood sample before, during and after treatment for infection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age between 18 and 80 years
- BMI 18 to 25
- presence of a bacterial infection
- pneumopathy (documented or probable)
- acute pyelonephritis / prostatitis
Key exclusion criteria (7 listed)
- patients with documented viral, parasitic or mycotic infections
- patients with bacterial infection> 4 weeks (eg endocarditis, osteoarticular infections)
- patients followed in intensive unit care
- patients with progressive cancerous pathology or malignant hemopathy diagnosed in the previous five years
- patients with systemic diseases (connective tissue diseases, vasculitis)
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 |
|---|---|---|
| blood sampleblood sample before, during and after infection treatment | Biological | Interventional arm |
Primary outcome
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
Time frame: 1 month
Description of an immunological profile of inflammation using current inflammatory cytokines during sepsis in non-obese subjects in comparison with this same profile in obese subjects
adipokin analysis (leptine, adiponectine)
Time frame: 1 month
Description of the kinetics of 2 cytokines more speficically involved in obesity (leptine, adipokinine) during sepsis in non-obese subjects in comparison with this same profile in obese subjects
leptin polymorphism analysis
Time frame: 1 month
Description of the genetic polymorphism of leptine and leptine receptor in non-obese subjects in comparison with this same profile in obese subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Infection, run by Versailles Hospital 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 9 inclusion and 7 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 13 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meckenstock (+331 39 63 93 19, rmeckenstock@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ) (time frame: 1 month). The study lists 3 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 13 May 2019.