Clinical trial NCT03651115: TDM of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.
Official title: Therapeutic Drug Monitoring of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Sample for Routine Care
Term or Premature Newborns (28 to 44 Amenorrhea Weeks)
Gentamicin and/or Vancomycin
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 28
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 new-born term or premature (50 gentamicin, 50 vancomycin)

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sampling time for vancomycin concentration
timeFrame: Day 3
measure: Sampling time for gentamycin concentration
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
Study officials:
References: