Infectious DiseasesINFECTIOTEKNCT06722131
Biobank of Samples From Patients With Infectious Diseases
An observational study of Infectious Diseases, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The aim of the INFECTIOTEK biobank will be to prospectively build a biobank of multiple biological samples from patients with infectious diseases in order to identify diagnostic and prognostic biomarkers, genetic susceptibility factors and immune response mechanisms in such diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- Sampling
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients treated in the Infectious Diseases Departments of Saint-Louis and Lariboisière Hospitals, with a diagnosis of infectious disease, and who have biological samples in the context of their routine medical care
Who may be able to join
- Patient over 18 years of age
- Diagnosed with one of the following infectious diseases :
- Infection with HIV-1 or HIV-2, or person at risk of infection with HIV
- Viral hepatitis (HAV, HBV, HCV, HDV, HEV)
- Pulmonary infections: bacterial (notably Nocardia), viral (Influenza, RSV, SARS-CoV-2, Adenovirus), fungal (Aspergillus, Mucorales)
- Urinary tract infections
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- Sexually transmitted infections (Neisseria gonorrheae, Chlamydia trachomatis, Mycoplasma genitalium, Treponema pallidum)
- Neuromeningeal infections: (Neisseria meningitidis, Streptococcus pneumoniae), viral (HSV, VZV), fungal (Cryptococcus).
- Infections affecting immunocompromised patients: herpes viruses (HSV, VZV, CMV, EBV), polyomavirus BK
- Emerging pathogen X (in the event of an epidemic)
- Signature of research consent form
- Health coverage with social security system or state medical aid
Who cannot join
- Refusal to participate
- Inability to give consent (cognitive impairment etc...)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Création d'Une biothèque de prélèvements de Patients présentant Une Pathologie Infectieuse
The aim of the INFECTIOTEK biobank will be to prospectively build a biobank of multiple biological samples from patients with infectious diseases in order to identify diagnostic and prognostic biomarkers, genetic susceptibility factors and immune response mechanisms in such diseases.
The population of the study will consist of patients treated in the Infectious Diseases Departments of Saint-Louis and Lariboisière Hospitals, with a diagnosis of infectious disease, and who have biological samples in the context of their routine medical care.
The diseases studied in this research project are bacterial infections (urinary tract infections, neurologic infections, sexually transmitted infections, pulmonary infections), viral infections (HIV, hepatitis, respiratory viruses, viruses affecting immunocompromised patients) and fungal infections (Aspergillus, Mucorales, Cryptococcus). These diseases are the domains of expertise and research of the clinical and biological teams at the Saint-Louis and Lariboisière hospitals.
- Conditions
- Infectious Diseases
- Being tested
- Sampling
- Keywords
- Biobank, Bacterial, viral and fungal diseases
- Medical subject headings
- Communicable Diseases, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingOther
Additional biological sampling at the same time as routine-care samples taken in the context of the diagnosis of the infectious disease and if planned at one and 12 months of follow-up
- The considered samples are as follows :
- Blood sample tubes (5 x 5 mL tubes, i.e. 25 mL)
- Infection site sample if applicable :
- Urine (10 mL)
- Stool (1 mL)
- CSF (1 mL)
- Sputum (1 mL) or bronchoalveolar lavage fluid (10 mL)
- Nasopharyngeal swab (one swab)
- Genital swab (one swab)
- Skin swab (one swab)
- Biopsy (a fragment of a lung, kidney or brain biopsy, if performed)
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with an infectious disease | Not described Receives: Other: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performances of new biomarkers to identify infection
Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Positive Likelihood Ratio, Negative Likelihood Ratio of the new biomarker
Measured: At diagnosis
Secondary outcomes (2)
Description of pathophysiological phenomena
Resistance mechanisms, virulence parameters, immune responses to the infectious agent, susceptibility factors to infections
Measured: Until 12 months
Description of prognostic biomarkers
Measured: Until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 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
- NCT06722131
- Sponsor's protocol ID
- APHP240413
- Acronym
- INFECTIOTEK
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Création d'Une biothèque de prélèvements de Patients présentant Une Pathologie Infectieuse
- ClinicalTrials.gov ID
- NCT06722131
- Acronym / sponsor ID
- INFECTIOTEK / APHP240413
- Conditions
- Infectious Diseases
- Keywords
- Biobank, Bacterial, viral and fungal diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 9 Dec 2024 (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 aim of the INFECTIOTEK biobank will be to prospectively build a biobank of multiple biological samples from patients with infectious diseases in order to identify diagnostic and prognostic biomarkers, genetic susceptibility factors and immune response mechanisms in such diseases.
The population of the study will consist of patients treated in the Infectious Diseases Departments of Saint-Louis and Lariboisière Hospitals, with a diagnosis of infectious disease, and who have biological samples in the context of their routine medical care.
The diseases studied in this research project are bacterial infections (urinary tract infections, neurologic infections, sexually transmitted infections, pulmonary infections), viral infections (HIV, hepatitis, respiratory viruses, viruses affecting immunocompromised patients) and fungal infections (Aspergillus, Mucorales, Cryptococcus). These diseases are the domains of expertise and research of the clinical and biological teams at the Saint-Louis and Lariboisière hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with an infectious disease | – | Other: Sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in the Infectious Diseases Departments of Saint-Louis and Lariboisière Hospitals, with a diagnosis of infectious disease, and who have biological samples in the context of their routine medical care
Key inclusion criteria (12 listed)
- Patient over 18 years of age
- Diagnosed with one of the following infectious diseases :
Key exclusion criteria (2 listed)
- Refusal to participate
- Inability to give consent (cognitive impairment etc...)
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 |
|---|---|---|
| SamplingAdditional biological sampling at the same time as routine-care samples taken in the context of the diagnosis of the infectious disease and if planned at one and 12 months of follow-up * The considered samples are as follows : * Blood sample tubes (5 x 5 mL tubes, i.e. 25 mL) * Infection site sample if applicable : * Urine (10 mL) * Stool (1 mL) * CSF (1 mL) * Sputum (1 mL) or bronchoalveolar lavage fluid (10 mL) * Nasopharyngeal swab (one swab) * Genital swab (one swab) * Skin swab (one swab) * Biopsy (a fragment of a lung, kidney or brain biopsy, if performed) | Other | Patients diagnosed with an infectious disease |
Primary outcome
Diagnostic performances of new biomarkers to identify infection
Time frame: At diagnosis
Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Positive Likelihood Ratio, Negative Likelihood Ratio of the new biomarker
2 secondary outcomes
Description of pathophysiological phenomena
Time frame: Until 12 months
Description of prognostic biomarkers
Time frame: Until 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Diseases, 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 12 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Dec 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Rubenstein, MD (142499066 ext. +33, emma.rubenstein@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performances of new biomarkers to identify infection (time frame: At diagnosis). 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 9 Dec 2024.