Blood Sample for Routine Care Clinical Trial
— MIDOMENOfficial title:
Therapeutic Drug Monitoring of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.
| Verified date | July 2018 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | September 2019 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 28 Weeks to 44 Years |
| Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Caen | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sampling time for vancomycin concentration | Day 3 | ||
| Primary | Sampling time for gentamycin concentration | Day 2 |