TDM of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.

NCT ID: NCT03651115

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2019-09-30

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.

Conditions

Blood Sample for Routine Care; Term or Premature Newborns (28 to 44 Amenorrhea Weeks); Gentamicin and/or Vancomycin

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Neonates with gentamicin

therapeutic drug monitoring

Intervention Type: DIAGNOSTIC_TEST

To monitor the blood concentrations of gentamicin and vancomycin

Neonates with vancomycin

therapeutic drug monitoring

Intervention Type: DIAGNOSTIC_TEST

To monitor the blood concentrations of gentamicin and vancomycin

Interventions

therapeutic drug monitoring

To monitor the blood concentrations of gentamicin and vancomycin

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Caen

Caen, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

KASSEL Christophe

Role: primary

directiongenerale@chu-caen.fr

0231063106 ext. +33

Other Identifiers

MIDOMEN 16-024

Identifier Type: -

Identifier Source: org_study_id