NCT02079298

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Anders Rane, MD, PhD, Senior professor · Academic / Other
• Sex: All
• Age: 23 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

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 because of fungal infection prophylaxis and/or patent ductus arteriosis (PDA), respectively, as measurement of the possible interactions between these drugs.

Conditions

• Ductus Arteriosis, Patent
• Bacterial Infections and Mycoses

Interventions

Type	Name	Description
DRUG	Treatment with fluconazole.
DRUG	2. Treatment with both fluconazole and Ibuprofen.
DRUG	3. Treatment with ibuprofen.
OTHER	4. No treatment with either fluconazole nor ibuprofen.

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-03-05
• Last updated: 2015-09-02

Locations

1 site across 1 country: Sweden