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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079298
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Anders Rane, MD, PhD, Senior professor, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ductus Arteriosis, Patent Bacterial Infections and Mycoses 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. Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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 Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Arm Intervention/treatment
Active Comparator: 1
Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole.
Drug: Treatment 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.
Drug: 2. Treatment 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.
Drug: 3. Treatment 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.
Other: 4. No treatment with either fluconazole nor ibuprofen.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02079298


Locations
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Sweden
Neonatal Intensive Care Unit, Karolinska University Hopsital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Anders Rane, MD, PhD, Senior professor
Karolinska University Hospital
Investigators
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Study Director: Anders Rane, Prof. MD Karolinska Institutet

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Responsible Party: Anders Rane, MD, PhD, Senior professor, Senior professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02079298    
Other Study ID Numbers: EudraCT number: 2013-003611-21
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Mycoses
Bacterial Infections
Fluconazole
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors