Population Pharmacokinetics of Fluconazole in the Treatment of Neonatal Fungal Infectious Disease
NCT ID: NCT05775692
Last Updated: 2023-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2020-01-01
2023-12-31
Brief Summary
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Detailed Description
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At different timepoint after fluconazole administration, plasma samples of 50 newborns and children will be collected from neonatal intensive care unit (NICU) and pneumology department for fluconazole. The clinical information includes demography, medication, concentration data, blood biochemical parameters and so on .
Plasma samples will be tested by high performance liquid chromatography (HPLC). PPK models of fluconazole will be established by NONMEM program. The reliability and stability of the PPK model will be evaluated by 1000 times of Bootstrap procedure and normalized predictive distribution error (NPDE).
2. Evaluation of the clinical feasibility and safety of individualized dosing.
According the results of PPK models, we will use dosages recommended in models to cure children infectious diseases in prospective studies. For fluconazole, 150 newborns and children will be collected.
We will compare the therapeutic effects and safety between newborns and children with conventional therapies and those with individualized therapies, including proportions of newborns and children with effective fluconazole concentration, improvement speed of of newborns and children, liver and kidney functions, adverse reactions of drugs, and so on.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newborns and children with the usage of fluconazole
Newborn with fluconazole against infectious diseases.
fluconazole
According to the models of population pharmacokinetics,the investigators and want to correlate use of fluconazole with treatment effectiveness and safety in newborns
Interventions
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fluconazole
According to the models of population pharmacokinetics,the investigators and want to correlate use of fluconazole with treatment effectiveness and safety in newborns
Eligibility Criteria
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Inclusion Criteria
Newborns infectious diseases include pneumonia, sepsis, purulent meningitis and other diseases with infection.
Informed consent signed by the parents and/or guardians.
Exclusion Criteria
2. Receiving other experimental drugs;
3. There are other factors that clinicians consider unsuitable for inclusion in the study.
1 Minute
28 Days
ALL
No
Sponsors
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Shandong University
OTHER
Beijing Children's Hospital
OTHER
Responsible Party
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Adong Shen
Deputy Chief of China National Clinical Research Center for Respiratory Diseases
Principal Investigators
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A-Dong Shen, Master
Role: PRINCIPAL_INVESTIGATOR
Beijing Children's Hospital of Capital Medical University
Locations
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Beijing Children's Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhao W, Lopez E, Biran V, Durrmeyer X, Fakhoury M, Jacqz-Aigrain E. Vancomycin continuous infusion in neonates: dosing optimisation and therapeutic drug monitoring. Arch Dis Child. 2013 Jun;98(6):449-53. doi: 10.1136/archdischild-2012-302765. Epub 2012 Dec 19.
Leroux S, Zhao W, Betremieux P, Pladys P, Saliba E, Jacqz-Aigrain E; French Society of Neonatology. Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national survey. Arch Dis Child. 2015 Apr;100(4):394-8. doi: 10.1136/archdischild-2014-306873. Epub 2015 Jan 27.
Jacqz-Aigrain E, Leroux S, Zhao W, van den Anker JN, Sharland M. How to use vancomycin optimally in neonates: remaining questions. Expert Rev Clin Pharmacol. 2015;8(5):635-48. doi: 10.1586/17512433.2015.1060124. Epub 2015 Aug 4.
Other Identifiers
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NCT2020
Identifier Type: -
Identifier Source: org_study_id
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