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

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ClinicalTrials.gov Identifier: NCT03651115
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.


Condition or disease Intervention/treatment
Blood Sample for Routine Care Term or Premature Newborns (28 to 44 Amenorrhea Weeks) Gentamicin and/or Vancomycin Diagnostic Test: therapeutic drug monitoring

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Therapeutic Drug Monitoring of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Group/Cohort Intervention/treatment
Neonates with gentamicin Diagnostic Test: therapeutic drug monitoring
To monitor the blood concentrations of gentamicin and vancomycin

Neonates with vancomycin Diagnostic Test: therapeutic drug monitoring
To monitor the blood concentrations of gentamicin and vancomycin




Primary Outcome Measures :
  1. Sampling time for vancomycin concentration [ Time Frame: Day 3 ]
  2. Sampling time for gentamycin concentration [ Time Frame: Day 2 ]


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Ages Eligible for Study:   28 Weeks to 44 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 new-born term or premature (50 gentamicin, 50 vancomycin)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651115


Locations
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France
CHU de Caen Recruiting
Caen, France, 14033
Contact: KASSEL Christophe    0231063106 ext +33    directiongenerale@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03651115     History of Changes
Other Study ID Numbers: MIDOMEN 16-024
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vancomycin
Premature Birth
Amenorrhea
Menstruation Disturbances
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action