CompletedPhase 4

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

Sweden80 participantsStarted 2014-04

Plain-language 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.

Who can participate

Age range23 Weeks – 42 Weeks

SexALL

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Inclusion criteria

✓. 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 Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole.
✓.2 Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated with both fluconazole and Ibuprofen.
✓.3 Premature newborn infants with Gestational Age 27+0 to 36+6 who are treated only with ibuprofen.
✓.4 Premature newborn infants with Gestational Age 27+0 to 36+6 and fullterm infants who are not treated either with fluconazole or ibuprofen.
✓. Parents that are in command of the Swedish language and capable of understanding the study plan
✓. Informed written parental consent

Exclusion criteria

✕. 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.
✕. Infants without possibility to conceive the objectives and implications of the study in the opinion of the investigator.

What they're measuring

Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter.

Timeframe: 5 days

Trial details

NCT IDNCT02079298

SponsorAnders Rane, MD, PhD, Senior professor

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Ductus Arteriosis, Patent trials