Informations générales (source: ClinicalTrials.gov)
Therapeutic Drug Monitoring of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling. (MIDOMEN)
Observational
University Hospital, Caen (Voir sur ClinicalTrials)
décembre 2017
septembre 2019
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Caen - 14033 - Caen - France | KASSEL Christophe | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
- 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)
- 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