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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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

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Ductus Arteriosis, Patent Bacterial Infections and Mycoses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole.

Group Type ACTIVE_COMPARATOR

Treatment with fluconazole.

Intervention Type DRUG

2

Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated with both fluconazole and Ibuprofen.

Group Type ACTIVE_COMPARATOR

2. Treatment with both fluconazole and Ibuprofen.

Intervention Type DRUG

3

Premature newborn infants with Gestational Age 27+0 to 36+6 who are treated only with ibuprofen.

Group Type ACTIVE_COMPARATOR

3. Treatment with ibuprofen.

Intervention Type DRUG

4

Premature newborn infants with Gestational Age 27+0 to 36+6 and fullterm infants who are not treated either with fluconazole or ibuprofen.

Group Type PLACEBO_COMPARATOR

4. No treatment with either fluconazole nor ibuprofen.

Intervention Type OTHER

Interventions

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Treatment with fluconazole.

Intervention Type DRUG

2. Treatment with both fluconazole and Ibuprofen.

Intervention Type DRUG

3. Treatment with ibuprofen.

Intervention Type DRUG

4. No treatment with either fluconazole nor ibuprofen.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

23 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No