Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants
Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ductus Arteriosis, Patent; Bacterial Infections and Mycoses
Intervention: Treatment with fluconazole. (Drug); 2. Treatment with both fluconazole and Ibuprofen. (Drug); 3. Treatment with ibuprofen. (Drug); 4. No treatment with either fluconazole nor ibuprofen. (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Anders Rane, MD, PhD, Senior professor Official(s) and/or principal investigator(s):
Anders Rane, Prof. MD, Study Director, Affiliation: Karolinska Institutet
Overall contact:
Anders Rane, MD Prof., Phone: +46 8 585 810 51, Email: anders.rane@ki.se
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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter.
Secondary outcome: Concentration of thromboxane A2 (TXA2) and prostacycline (PGI2) in relation to genetic variation of the enzymes of the Cytochrome (P4502C) family.Number of and type of Adverse Drug Reactions
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.
Eligibility
Minimum age: 23 Weeks.
Maximum age: 42 Weeks.
Gender(s): Both.
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 Arteriosis (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 Gestational Age 27+0 to 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
Exclusion Criteria:
1. Infants who need treatment with other drugs that are metabolised by enzyme Cytochrome
(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 cyclooxygenase.
2. Infants without possibility to conceive the objectives and implications of the study
in the opinion of the investigator.
Locations and Contacts
Anders Rane, MD Prof., Phone: +46 8 585 810 51, Email: anders.rane@ki.se
Neonatal Intensive Care Unit, Karolinska University Hopsital, Stockholm 171 76, Sweden; Not yet recruiting
Yinghua Li, MD, PhD, Phone: ยด+46 8 51778331, Email: yinghua.li@karolinska.se
Yinghua Li, MD PhD, Principal Investigator
Additional Information
Starting date: March 2014
Last updated: March 24, 2014
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