Intensive Care Unit SyndromeMON4STRATNCT03404089
Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care.
A study testing pharmacokinetic device in people with Intensive Care Unit Syndrome, run by University Hospital, Lille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- pharmacokinetic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2018to 30 Jun 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age younger than 18 years
- Newborns (preterm or not) in neonatal intensive care
- Infants, children, and adolescents in pediatric intensive care
- Clinically suspected or microbiologically proven sepsis that might be associated with ventilator-associated pneumonia or otherwise associated with health care
- Need for antibiotic treatment by piperacillin-tazobactam, ceftazidime, or meropenem of intermittent administration
- Informed consent form signed by parents/guardian
- Informed consent form signed by patients old enough to understand.
Who cannot join
- Process for active limitation of treatment underway
- Suspected or known hypersensitivity to studied beta-lactams
- Renal failure, defined as serum creatinine > 1.5 mg/dl or urine production < 0.3 ml/kg for 24 h or anuria for 12 h.
- Co-administration of two β-lactam antibiotics
- Cystic fibrosis
- No national health insurance coverage in French center
- Family unable to understand study-related information due to language or other communication issues
- No consent obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care: Study of a Pharmacokinetics Monitoring Method.
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.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- pharmacokinetic device
- Keywords
- device drug monitoring, β-lactam antibiotic, health care-associated infection, MON4STRAT
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacokinetic deviceDevice
MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement
pharmacokinetic deviceDevice
High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using
| Study group | Role | What they receive |
|---|---|---|
| pharmacokinetic device | Experimental | MON4STRAT system Receives: Device: pharmacokinetic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 3 days
Secondary outcomes (7)
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.
Measured: at 3 days
Minimum concentration of beta-lactams antibiotics
Pharmacokinetic of beta-lactams antibiotics
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start18 Apr 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: insufficient inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- François DUBOS, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404089
- Sponsor's protocol ID
- 2015_78
- Other IDs
- 2016-A01407-44, HEALTH.2013.2.3.1-2
- Acronym
- MON4STRAT
- Status last verified
- Jan 2023
- First submitted
- 28 Nov 2017
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care: Study of a Pharmacokinetics Monitoring Method.
- ClinicalTrials.gov ID
- NCT03404089
- Acronym / sponsor ID
- MON4STRAT / 2015_78
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- device drug monitoring, β-lactam antibiotic, health care-associated infection, MON4STRAT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient inclusions
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Jan 2018 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pharmacokinetic device | Experimental | Device: pharmacokinetic deviceMON4STRAT system |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age younger than 18 years
- Newborns (preterm or not) in neonatal intensive care
- Infants, children, and adolescents in pediatric intensive care
- Clinically suspected or microbiologically proven sepsis that might be associated with ventilator-associated pneumonia or otherwise associated with health care
- Need for antibiotic treatment by piperacillin-tazobactam, ceftazidime, or meropenem of intermittent administration
Key exclusion criteria (8 listed)
- Process for active limitation of treatment underway
- Suspected or known hypersensitivity to studied beta-lactams
- Renal failure, defined as serum creatinine > 1.5 mg/dl or urine production < 0.3 ml/kg for 24 h or anuria for 12 h.
- Co-administration of two β-lactam antibiotics
- Cystic fibrosis
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 |
|---|---|---|
| pharmacokinetic deviceMON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement | Device | pharmacokinetic device |
| pharmacokinetic deviceHigh performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using | Device | pharmacokinetic device |
Primary outcome
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
7 secondary outcomes
User's questionnaire
Time frame: at 3 days
Minimum concentration 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
Time frame: before antibiotic infusion at day 3 and 2/3 hours after the end of antibiotic infusion
Clearance (Cl) 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
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
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.
Time frame: at 17 days
Results and safety
The study was stopped early (reason given: insufficient inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
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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.
François DUBOS, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacokinetic device in people with Intensive Care Unit Syndrome, run by University Hospital, Lille 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 19 Jan 2023. 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 was stopped early (reason given: insufficient inclusions). Results are not available in the source record.
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?
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). 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 19 Jan 2023.