Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants

Overview

This study will investigate pharmacological interventions between fluconazole and ibuprofen when they are given to premature newborn babys. This in order to find out if the drugs are influencing each other when they are given at the same time. The study is meant to find out if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.

Full Title of Study: “Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants – A Study on Interactions by Nonsteroidal Anti Inflammatory Drugs (NSAIDs) With Fluconazole in Respect of Pharmacodynamic Endpoints With Urinary Excretion of Vasoactive Endobiotics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2015

Detailed Description

To evaluate the effect of fluconazole and/or ibuprofen on the urinary excretion of two vasoactive arachidonic acid products, thromboxane A2 (TXA2) and prostacycline (PGI2), in newborn infants treated with one or both of these drugs because of fungal infection prophylaxis and/or patent ductus arteriosis (PDA), respectively, as measurement of the possible interactions between these drugs.

Interventions

  • Drug: Treatment with fluconazole.
  • Drug: 2. Treatment with both fluconazole and Ibuprofen.
  • Drug: 3. Treatment with ibuprofen.
  • Other: 4. No treatment with either fluconazole nor ibuprofen.

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole.
  • Active Comparator: 2
    • Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated with both fluconazole and Ibuprofen.
  • Active Comparator: 3
    • Premature newborn infants with Gestational Age 27+0 to 36+6 who are treated only with ibuprofen.
  • Placebo Comparator: 4
    • Premature newborn infants with Gestational Age 27+0 to 36+6 and fullterm infants who are not treated either with fluconazole or ibuprofen.

Clinical Trial Outcome Measures

Primary Measures

  • Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter.
    • Time Frame: 5 days
    • To evaluate the effect of fluconazole and/or ibuprofen on the urinary excretion of two vasoactive arachidonic acid products, thromboxane A2 (TXA2) and prostacycline (PGI2), in newborn infants treated with one or both of these drugs for fungal infection prophylaxis and/or patent ductus arteriosis (PDA), respectively.

Secondary Measures

  • Concentration of thromboxane A2 (TXA2) and prostacycline (PGI2) in relation to genetic variation of the enzymes of the Cytochrome (P4502C) family.
    • Time Frame: 5 days
    • To evaluate if genetic variability in the enzyme Cytochrome (P4502C) influence the urinary excretion of two vasoactive arachidonic acid products: thromboxane A2 (TXA2) and prostacycline (PGI2) in newborn infants treated with fluconazole and/or ibuprofen.
  • Number of and type of Adverse Drug Reactions
    • Time Frame: 5 days
    • To evaluate safety of fluconazole and ibuprofen given separately or in combination to newborn infants with clinical indication for treatment with these drugs.

Participating in This Clinical Trial

Inclusion Criteria

1. Newborn infants in need of prophylaxis with fluconazole according to clinical routines and/or clinical indication for treatment of Patent Ductus Arteriosis (PDA), or newborn infants who are not treated with either fluconazole or ibuprofen according to the following study groups: 1.1 Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole. 1.2 Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated with both fluconazole and Ibuprofen. 1.3 Premature newborn infants with Gestational Age 27+0 to 36+6 who are treated only with ibuprofen. 1.4 Premature newborn infants with Gestational Age 27+0 to 36+6 and fullterm infants who are not treated either with fluconazole or ibuprofen. 2. Parents that are in command of the Swedish language and capable of understanding the study plan 3. Informed written parental consent Exclusion Criteria:

1. Infants who need treatment with other drugs that are metabolised by enzyme Cytochrome (CYP2C9) (such as phenytoin, sulphamethoxazole, fluvastatin, sildenafil, losartan, irbesartan, torsemide, tienilic acid), or any other enzyme involved in the metabolism of fluconazole and or NSAIDs, or treatment with drugs that interact with NSAIDs at the cyclooxygenase level, or interact with the vasal effects of the metabolic products of the cyclooxygenase. 2. Infants without possibility to conceive the objectives and implications of the study in the opinion of the investigator.

Gender Eligibility: All

Minimum Age: 23 Weeks

Maximum Age: 42 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Anders Rane, MD, PhD, Senior professor
  • Collaborator
    • Karolinska University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Anders Rane, MD, PhD, Senior professor, Senior professor – Karolinska Institutet
  • Overall Official(s)
    • Anders Rane, Prof. MD, Study Director, Karolinska Institutet

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