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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
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.
Details
| Lead sponsor | Anders Rane, MD, PhD, Senior professor |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 80 |
| Start date | 2014-04 |
| Completion | 2015-09 |
Conditions
- Ductus Arteriosis, Patent
- Bacterial Infections and Mycoses
Interventions
- Treatment with fluconazole.
- 2. Treatment with both fluconazole and Ibuprofen.
- 3. Treatment with ibuprofen.
- 4. No treatment with either fluconazole nor ibuprofen.
Primary outcomes
- Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter. — 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.
Countries
Sweden