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

• Conditions: Fungal infection prophylaxisPatent ductus arteriosus; MedDRA version: 16.1Level: PTClassification code 10034130Term: Patent ductus arteriosusSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 16.1Level: PTClassification code 10028924Term: Neonatal candida infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-003611-21-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-30
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified