Trial intelligence / Profile preview

Safety of Fluconazole and Ibuprofen Interaction in Newborns

NCT02079298Phase 4

Key facts

Status: Completed
Start: Apr 2014
Primary completion: Sep 2015
Countries: 1
Modality: Orthosteric Ligands

Drugs: fluconazoleibuprofen
Conditions: fungal infectionpatent ductus arteriosus (PDA)

Overview

Phase 4, open-label trial of fluconazole and ibuprofen in fungal infection and patent ductus arteriosus (PDA) (4 arms). Primary endpoint: Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) at 5 days. Started Apr 2014; status: completed.

Design

4 arms

Study design: Non-randomizedOpen-label

Fluconazole Only
Premature infants (23-26w) treated with Fluconazole.
Fluconazole + Ibuprofen
Premature infants (23-26w) treated with Fluconazole and Ibuprofen.
Ibuprofen Only
Premature infants (27-36w) treated with Ibuprofen.
No Treatment
Premature (27-36w) and full-term infants receiving no treatment.

Who it enrols

Newborn infants in need of prophylaxis with fluconazole or treatment for PDA, or those not treated with either. Parents must understand Swedish.

Endpoints

Primary

Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2)5 days

Secondary

Concentration of thromboxane A2 (TXA2) and prostacycline (PGI2) in relation to genetic variation of the enzymes of the Cytochrome (P4502C) family5 days
Number of and type of Adverse Drug Reactions5 days

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