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

Primary Purpose

Ductus Arteriosis, Patent, Bacterial Infections and Mycoses

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Treatment with fluconazole.
2. Treatment with both fluconazole and Ibuprofen.
3. Treatment with ibuprofen.
4. No treatment with either fluconazole nor ibuprofen.
Sponsored by
Anders Rane, MD, PhD, Senior professor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ductus Arteriosis, Patent

Eligibility Criteria

23 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neonatal Intensive Care Unit, Karolinska University Hopsital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Concentration of thromboxane A2 (TXA2) and prostacycline (PGI2) in relation to genetic variation of the enzymes of the Cytochrome (P4502C) family.
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
To evaluate safety of fluconazole and ibuprofen given separately or in combination to newborn infants with clinical indication for treatment with these drugs.

Full Information

First Posted
February 26, 2014
Last Updated
September 1, 2015
Sponsor
Anders Rane, MD, PhD, Senior professor
Collaborators
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02079298
Brief Title
Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Rane, MD, PhD, Senior professor
Collaborators
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductus Arteriosis, Patent, Bacterial Infections and Mycoses

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated with both fluconazole and Ibuprofen.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Premature newborn infants with Gestational Age 27+0 to 36+6 who are treated only with ibuprofen.
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Premature newborn infants with Gestational Age 27+0 to 36+6 and fullterm infants who are not treated either with fluconazole or ibuprofen.
Intervention Type
Drug
Intervention Name(s)
Treatment with fluconazole.
Intervention Type
Drug
Intervention Name(s)
2. Treatment with both fluconazole and Ibuprofen.
Intervention Type
Drug
Intervention Name(s)
3. Treatment with ibuprofen.
Intervention Type
Other
Intervention Name(s)
4. No treatment with either fluconazole nor ibuprofen.
Primary Outcome Measure Information:
Title
Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter.
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Concentration of thromboxane A2 (TXA2) and prostacycline (PGI2) in relation to genetic variation of the enzymes of the Cytochrome (P4502C) family.
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.
Time Frame
5 days
Title
Number of and type of Adverse Drug Reactions
Description
To evaluate safety of fluconazole and ibuprofen given separately or in combination to newborn infants with clinical indication for treatment with these drugs.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Parents that are in command of the Swedish language and capable of understanding the study plan Informed written parental consent Exclusion Criteria: 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. Infants without possibility to conceive the objectives and implications of the study in the opinion of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Rane, Prof. MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Neonatal Intensive Care Unit, Karolinska University Hopsital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

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

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