Fungal infection prophylaxis Patent ductus arteriosus MedDRA version: 16.1 Level: PT Classification code 10034130 Term: Patent ductus arteriosus System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1 Level: PT Classification code 10028924 Term: Neonatal candida infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Fluconazol Fresenius Kabi
Pharmaceutical Form:
Other descriptive name: FLUCONAZOLE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Tr
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 arteriosus (PDA), respectively.;Secondary Objective: 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. To evaluate safety of fluconazole and ibuprofen given separately or in combination to newborn infants with clinical indication for treatment with these drugs. ;Primary end point(s): Urine secretion of two vasoactive arachidonic acid products; thromboxane A2 (TXA2) and prostacycline (PGI2).;Timepoint(s) of evaluation of this end point: Age between 1-2 days Age between 3- 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse drug reactions;Timepoint(s) of evaluation of this end point: During the treatment period. | — |
Countries
Sweden
Contacts
Public ContactAnders Rane /Anna Käll
Karolinska Institutet/Karolinska Trial Alliance
Outcome results
None listed