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Report for Clinical Trial NCT02079298

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT02079298 Ductus Arteriosis, Patent Bacterial Infections and Mycoses
MeSH:Mycoses Bacterial Infect Bacterial Infections

4 Interventions

Name: Treatment with fluconazole.

Type: Drug
Group Labels: 1

1

Name: 2. Treatment with both fluconazole and Ibuprofen.

Type: Drug
Group Labels: 1

2

Name: 3. Treatment with ibuprofen.

Type: Drug
Group Labels: 1

3

Name: 4. No treatment with either fluconazole nor ibuprofen.

Type: Other
Group Labels: 1

4


Primary Outcomes

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 for fungal infection prophylaxis and/or patent ductus arteriosis (PDA), respectively.

Measure: Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter.

Time: 5 days

Secondary Outcomes

Description: 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.

Measure: Concentration of thromboxane A2 (TXA2) and prostacycline (PGI2) in relation to genetic variation of the enzymes of the Cytochrome (P4502C) family.

Time: 5 days

Description: To evaluate safety of fluconazole and ibuprofen given separately or in combination to newborn infants with clinical indication for treatment with these drugs.

Measure: Number of and type of Adverse Drug Reactions

Time: 5 days

Purpose: Supportive Care

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 P4502C

Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter.. 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.. Concentration of thromboxane A2 (TXA2) and prostacycline (PGI2) in relation to genetic variation of the enzymes of the Cytochrome (P4502C) family.. --- P4502C ---

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.. Number of and type of Adverse Drug Reactions. --- P4502C ---



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