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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.

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:

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.

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

Placebo Comparator

Arm Label

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

NCT ID

NCT02079298

First Posted

February 26, 2014

Last Updated

September 1, 2015

Sponsor

Anders Rane, MD, PhD, Senior professor

Collaborators

Karolinska University Hospital

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

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

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

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

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

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

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

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

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

Learn more about this trial

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

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