EmergenciesNEOPOPINCT03987100
Population Pharmacokinetics of Amoxicillin in Neonates
An observational study of Emergencies, run by Rennes University Hospital at 1 site in France.
Trial summary
The objective of NEOPOPI is to conduct a population pharmacokinetic study of amoxicillin in neonates, in order to evaluate and optimize neonatal dose regimen. There will be no change to the medication treatment received by participants. Read more about this study
- Who is it for?
- Ages Up to 44 weeks
- Conditions the study is for
- Emergencies
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2019to Aug 2021
- Phase
- Observational
- 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 44 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates (including both preterm and full-term neonates) receiving amoxicillin as part of their routine clinical care (for suspected or proven neonatal sepsis).
Who may be able to join
- Neonates receiving amoxicillin and blood/CSF tests during amoxicillin treatment, as part of their routine clinical care
- No parental opposition to the study participation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Rennes
Rennes, 35000
Stuart Byrom, 0033 (0)299284312, stuart.byrom@chu-rennes.fr
About this study
Official title: Population Pharmacokinetics of Amoxicillin in Neonates: Evaluation and Optimization of the Dose
The objective of NEOPOPI is to conduct a population pharmacokinetic study of amoxicillin in neonates, in order to evaluate and optimize neonatal dose regimen.
There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.
Read the detailed description
- Administration of the antibiotic according to the usual procedures for prescribing services: in particular, neither the indications nor the doses nor the methods of administration are fixed by the protocol
- Opportunistic sampling strategy: no biological samples are specifically collected for the purposes of the study (measurements of concentrations on "bottoms" or "left-over" samples); the performance of this non-invasive sampling strategy has been previously demonstrated in the neonatal population.
- Micro-analytical method (assay of concentrations on micro-volumes, of the order of 50μL)
- Population pharmacokinetic analysis
- Conditions
- Emergencies
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement rate of therapeutic efficacy target of amoxicillin
Achievement rate of therapeutic efficacy target of amoxicillin (ie percentage of neonates in whom amoxicillin plasma concentration remains above the MIC of target organisms for more than 70% of the dose range). In accordance with the recommendations of the European Medicines Agency, the optimal dosage regimen is defined as leading to a probability of antibiotic therapy success of greater than or equal to 90%. Thus, it is necessary to determine the dosage regimen allowing the target of therapeutic efficacy to be reached (ie maintenance of the plasma concentration of amoxicillin greater than the MIC of the targeted microorganisms for more than 70% of the dose) in at least 90% of treated neonates.
Measured: 1 week
Secondary outcomes (3)
Recording of Adverse Events
Recording of adverse events (clinical and / or biological) during the treatment period and up to 96 hours after the end of treatment
Measured: 1 week
Minimum Inhibitory Concentration
Collection of MICs of amoxicillin for isolated germs. For amoxicillin the antibacterial activity is time-dependent, the predictor of efficacy is the "Time> MIC": this is the percentage of the administration interval during which the concentration of the antibiotic remains higher than the MIC of target germs
Measured: 1 week
Concentration of amoxicilin in Cerebrospinal Fluid (CSF)
Calculation of amoxicillin concentration in CSF / amoxicillin plasma concentration when data permits (i.e. when lumbar puncture is performed as part of usual care, during treatment with amoxicillin
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start5 Feb 2019
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987100
- Sponsor's protocol ID
- 35RC18-9874
- Acronym
- NEOPOPI
- Status last verified
- Jun 2019
- First submitted
- 9 Jan 2019
- Last updated
- 14 Jun 2019
- 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 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Amoxicillin in Neonates: Evaluation and Optimization of the Dose
- ClinicalTrials.gov ID
- NCT03987100
- Acronym / sponsor ID
- NEOPOPI / 35RC18-9874
- Conditions
- Emergencies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 14 Jun 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 objective of NEOPOPI is to conduct a population pharmacokinetic study of amoxicillin in neonates, in order to evaluate and optimize neonatal dose regimen.
There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.
Detailed description
- Administration of the antibiotic according to the usual procedures for prescribing services: in particular, neither the indications nor the doses nor the methods of administration are fixed by the protocol
- Opportunistic sampling strategy: no biological samples are specifically collected for the purposes of the study (measurements of concentrations on "bottoms" or "left-over" samples); the performance of this non-invasive sampling strategy has been previously demonstrated in the neonatal population.
- Micro-analytical method (assay of concentrations on micro-volumes, of the order of 50μL)
- Population pharmacokinetic analysis
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates (including both preterm and full-term neonates) receiving amoxicillin as part of their routine clinical care (for suspected or proven neonatal sepsis).
Key inclusion criteria (2 listed)
- Neonates receiving amoxicillin and blood/CSF tests during amoxicillin treatment, as part of their routine clinical care
- No parental opposition to the study participation
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Achievement rate of therapeutic efficacy target of amoxicillin
Time frame: 1 week
Achievement rate of therapeutic efficacy target of amoxicillin (ie percentage of neonates in whom amoxicillin plasma concentration remains above the MIC of target organisms for more than 70% of the dose range). In accordance with the recommendations of the European Medicines Agency, the optimal dosage regimen is defined as leading to a probability of antibiotic therapy success of greater than or equal to 90%. Thus, it is necessary to determine the dosage regimen allowing the target of therapeutic efficacy to be reached (ie maintenance of the plasma concentration of amoxicillin greater than the MIC of the targeted microorganisms for more than 70% of the dose) in at least 90% of treated neonates.
3 secondary outcomes
Recording of Adverse Events
Time frame: 1 week
Minimum Inhibitory Concentration
Time frame: 1 week
Concentration of amoxicilin in Cerebrospinal Fluid (CSF)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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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?
An observational study of Emergencies, run by Rennes University 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 2 inclusion and 1 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 14 Jun 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 Stuart Byrom (0033 (0)299284312, stuart.BYROM@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement rate of therapeutic efficacy target of amoxicillin (time frame: 1 week). 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 14 Jun 2019.