Blood Sample for Routine CareMIDOMENNCT03651115
TDM of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.
An observational study of Blood Sample for Routine Care and Term or Premature Newborns (28 to 44 Amenorrhea Weeks), run by University Hospital, Caen at 1 site in France.
Trial summary
Gentamicin and vancomycin, widely used in neonatology, are antibiotics with a narrow therapeutic index and a risk of nephrotoxicity and ototoxicity. For these drugs, therapeutic drug monitoring (TDM) is required, to optimize the efficacy and tolerance of these antibiotics. Read more about this study
- Who is it for?
- Ages 28 weeks to 44 years
- Conditions the study is for
- Blood Sample for Routine Care, Term or Premature Newborns (28 to 44 Amenorrhea Weeks), Gentamicin and/or Vancomycin
- What is being tested?
- therapeutic drug monitoring
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2017to Sep 2019
- 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 28 weeks to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 100 new-born term or premature (50 gentamicin, 50 vancomycin)
Who may be able to join
- Term or premature newborns who receive one or two antibiotics (gentamicin, vancomycin) and who could benefit from pharmacological dosages of these drugs
- Premature from age 28 amenorrhea weeks
- Newborns up to 44 weeks corrected age
- Newborns at term / premature having a blood sample provided for routine care (capillary or venous sampling for blood glucose, blood gas, hemoglobinemia, sodium, potassium, lactate, bilirubin)
Who cannot join
- Premature before age 28 amenorrhea weeks corrected
- Newborns over 44 weeks of age corrected
- Hemostasis disorders
- Hemoglobinopathies
- Hearing or kidney malformation
- Absence of blood sampling as part of the routine care
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Caen
Caen, 14033
KASSEL Christophe, 0231063106 ext. +33, directiongenerale@chu-caen.fr
About this study
Official title: Therapeutic Drug Monitoring of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.
Gentamicin and vancomycin, widely used in neonatology, are antibiotics with a narrow therapeutic index and a risk of nephrotoxicity and ototoxicity. For these drugs, therapeutic drug monitoring (TDM) is required, to optimize the efficacy and tolerance of these antibiotics.
In newborns, the TDM of these antibiotics is really available, because of physiological features, such as renal elimination and hepatic metabolism which are both very dependent on age and maturation. Thus, in newborn, there is a large interindividual variability of pharmacokinetic parameters, making the dosage adjustment of antibiotics very difficult.
Read more
Unfortunately, because of a limited blood mass, the TDM of these antibiotics is very rarely practiced in these children. The introduction of a Died blood spot (DBS), which uses only a single drop of blood (<50 μL) preserved in dried form, thus makes it possible to reduce the blood volume taken and avoid the venous intrusion. The dosage needs the use of liquid chromatography coupled with tandem mass spectrometry (LC-MSMS), the only sensitive technique to work with such a low blood volume.
We therefore wish to develop this approach coupling DBS and LC-MSMS, in neonatology, to evaluate the concentration of these nephrotoxic antibiotics (gentamicin and vancomycin), as TDM. The blood concentrations of the antibiotic, per 100 new-born term or premature (50 gentamicin, 50 vancomycin), are compared to the physiological state of the child (premature or not, intrauterine growth retardation or not), its hemodynamic status (shock or not) and its efficacy / toxicity, evaluated by the clinician using a questionnaire.
The use of this new sampling method, as an alternative to conventional blood sampling, makes it possible to better monitor the concentrations of gentamicin and vancomycin in neonatalogy, thus reducing the risk of toxicity of these antibiotics.
- Conditions
- Blood Sample for Routine Care, Term or Premature Newborns (28 to 44 Amenorrhea Weeks), Gentamicin and/or Vancomycin
- Being tested
- therapeutic drug monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic drug monitoringDiagnostic test
To monitor the blood concentrations of gentamicin and vancomycin
| Study group | Role | What they receive |
|---|---|---|
| Neonates with gentamicin | Not described Receives: Diagnostic Test: therapeutic drug monitoring | |
| Neonates with vancomycin | Not described Receives: Diagnostic Test: therapeutic drug monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sampling time for vancomycin concentration
Measured: Day 3
Sampling time for gentamycin concentration
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start15 Dec 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Sample for Routine CareStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651115
- Sponsor's protocol ID
- MIDOMEN 16-024
- Acronym
- MIDOMEN
- Status last verified
- Jul 2018
- First submitted
- 13 Aug 2018
- Last updated
- 29 Aug 2018
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.
- ClinicalTrials.gov ID
- NCT03651115
- Acronym / sponsor ID
- MIDOMEN / MIDOMEN 16-024
- Conditions
- Blood Sample for Routine Care, Term or Premature Newborns (28 to 44 Amenorrhea Weeks), Gentamicin and/or Vancomycin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 29 Aug 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.
Gentamicin and vancomycin, widely used in neonatology, are antibiotics with a narrow therapeutic index and a risk of nephrotoxicity and ototoxicity. For these drugs, therapeutic drug monitoring (TDM) is required, to optimize the efficacy and tolerance of these antibiotics.
In newborns, the TDM of these antibiotics is really available, because of physiological features, such as renal elimination and hepatic metabolism which are both very dependent on age and maturation. Thus, in newborn, there is a large interindividual variability of pharmacokinetic parameters, making the dosage adjustment of antibiotics very difficult.
Unfortunately, because of a limited blood mass, the TDM of these antibiotics is very rarely practiced in these children. The introduction of a Died blood spot (DBS), which uses only a single drop of blood (<50 μL) preserved in dried form, thus makes it possible to reduce the blood volume taken and avoid the venous intrusion. The dosage needs the use of liquid chromatography coupled with tandem mass spectrometry (LC-MSMS), the only sensitive technique to work with such a low blood volume.
We therefore wish to develop this approach coupling DBS and LC-MSMS, in neonatology, to evaluate the concentration of these nephrotoxic antibiotics (gentamicin and vancomycin), as TDM. The blood concentrations of the antibiotic, per 100 new-born term or premature (50 gentamicin, 50 vancomycin), are compared to the physiological state of the child (premature or not, intrauterine growth retardation or not), its hemodynamic status (shock or not) and its efficacy / toxicity, evaluated by the clinician using a questionnaire.
The use of this new sampling method, as an alternative to conventional blood sampling, makes it possible to better monitor the concentrations of gentamicin and vancomycin in neonatalogy, thus reducing the risk of toxicity of these antibiotics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates with gentamicin | – | Diagnostic Test: therapeutic drug monitoring |
| Neonates with vancomycin | – | Diagnostic Test: therapeutic drug monitoring |
Who may qualify
- Ages
- 28 weeks to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 100 new-born term or premature (50 gentamicin, 50 vancomycin)
Key inclusion criteria (4 listed)
- Term or premature newborns who receive one or two antibiotics (gentamicin, vancomycin) and who could benefit from pharmacological dosages of these drugs
- Premature from age 28 amenorrhea weeks
- Newborns up to 44 weeks corrected age
- Newborns at term / premature having a blood sample provided for routine care (capillary or venous sampling for blood glucose, blood gas, hemoglobinemia, sodium, potassium, lactate, bilirubin)
Key exclusion criteria (6 listed)
- Premature before age 28 amenorrhea weeks corrected
- Newborns over 44 weeks of age corrected
- Hemostasis disorders
- Hemoglobinopathies
- Hearing or kidney malformation
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 |
|---|---|---|
| therapeutic drug monitoringTo monitor the blood concentrations of gentamicin and vancomycin | Diagnostic test | Neonates with gentamicin, Neonates with vancomycin |
Primary outcome
Sampling time for vancomycin concentration
Time frame: Day 3
Sampling time for gentamycin concentration
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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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 Blood Sample for Routine Care and Term or Premature Newborns (28 to 44 Amenorrhea Weeks), run by University Hospital, Caen 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 4 inclusion and 6 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 29 Aug 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sampling time for vancomycin concentration (time frame: Day 3). The study lists 2 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 29 Aug 2018.