Safety of fluconazol treatment of premature and full-term newborns - a study on interactions by NSAIDs with fluconazole in respect of pharmacodynamic endpoints with urinary excretion of vasoactive endobiotics

Karolinska Institutet0 个研究点开始时间: 2013年10月30日最近更新: 2015年10月19日

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•1. Newborn infants in need of prophylaxis with fluconazole according to clinical routines and/or clinical indication for treatment of Patent Ductus Arteriosus (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 GA 27+0 to GA 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 80
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1 Infants who need treatment with other drugs that are metabolised by 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 cycloxygenase.
•2. Infants without possibility to conceive the objectives and implications of the study in the opinion of the investigator.

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