An interventional study of pharmacokinetic device and pharmacokinetic device in Intensive Care Unit Syndrome, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic
Among 47 studies in Cross Infection with a site in France — 9 open to participants now, 9 under way, 1 of them phase 3. Cross Infection · France.
Among the 47 studies in Cross Infection with a site in France, this one is the 22nd largest by enrollment of the 23 interventional ones that give a count, is one of 3 that started in 2018, is one of 14 with no phase, and was the 22nd registered.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
Browse Cross Infection studies →9 of the 47 studies in Cross Infection with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Régional Metz-Thionville · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
University Hospital, Lille · Sites in France
Ages 18+
University Hospital, Toulouse · Sites in France
Ages 18+
Hospices Civils de Lyon · Sites in France
Ages 18+ · Healthy volunteers
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 27 Cross Infection studies recruiting now, 22 (81%) set no upper age limit and 3 (11%) stop at 75 or younger; 5 take children under 18; 6 take healthy volunteers.
This study: Up to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2018.
This study's enrollment of 13 is below the median of 185 across 169 interventional studies indexed under Cross Infection.
Median enrollment 244 across the 23 interventional studies, 496 across the 24 observational. Of the 31 that completed or were terminated, 2 (6%) have results posted.
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2 of 47 have an industry lead sponsor. The 10 most frequent:
University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
University Hospital, Lille has 4 studies filed under Cross Infection — fewer than ten, so there is no comparison to draw.
4 of the studies in Cross Infection with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05719259European Clinical Research Alliance for Infectious Diseases (ECRAID)Perpetual Observational Study - Ventilator Associated Pneumonia | 2026-12-01 |
| NCT06482463University Hospital, ToulouseDiagnostic of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis | 2027-02 |
| NCT06643039Hospices Civils de LyonNosocomial Respiratory Virus Infection | 2027-07-05 |
| NCT07822971Centre Hospitalier Régional Metz-ThionvilleImpact of an On-site Simulation-based Training Programme on Adherence to Standard Precautions and Healthcare-associated Infections in Adult Intensive Care | 2027-08-31 |
Among the 47 studies in Cross Infection with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study evaluate the capacity of the MON4STRAT device for drug monitoring of β- lactam antibiotic concentrations in newborns, children, and adolescents admitted in intensive care units with a health care-associated infection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MON4STRAT system
Device: pharmacokinetic device
MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement
High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using
Correlation between the β-lactam dosage measured by the MON4STRAT method and the β-lactam dosage measured by the HPLC-MS-MS (the reference method).
Time frame: at 3 days
User's questionnaire
The feasibility of the MON4STRAT method will be evaluated by a questionnaire to be completed by the users of the method, that is, the nurses caring for these patients.
Time frame: at 3 days
Minimum concentration of beta-lactams antibiotics
Pharmacokinetic of beta-lactams antibiotics
Time frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Maximum concentration (CMax) of beta-lactams antibiotics
Pharmacokinetic of beta-lactams antibiotics
Time frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Clearance (Cl) of beta-lactams antibiotics
Pharmacokinetic of beta-lactams antibiotics
Time frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Volume of distribution of beta-lactams antibiotics
Pharmacokinetic of beta-lactams antibiotics
Time frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Half-life (t1/2) of beta-lactams antibiotics
Pharmacokinetic of beta-lactams antibiotics
Time frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Assessment of the course of infection of children who had a β-lactam assay (by the reference method) at the usual levels and those who appeared to receiving inadequate β-lactam doses.
Antimicrobial doses, serum concentration of β- lactams and minimum inhibitory concentration of microorganisms, if available, will be used to assess the potential usefulness of this bedside method
Time frame: at 17 days
Ran from Apr 2018 to primary completion in Jun 2019, 14 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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