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

NCT02079298 | Completed Phase 4

• 1 other identifier: EudraCT number: 2013-003611-21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductus Arteriosis, Patent; Bacterial Infections and Mycoses

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (2)

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

  5 days

• Number of and type of Adverse Drug Reactions

  5 days

Study Arms (4)

1

ACTIVE COMPARATOR

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

Drug: Treatment with fluconazole.

2

ACTIVE COMPARATOR

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

Drug: 2. Treatment with both fluconazole and Ibuprofen.

3

ACTIVE COMPARATOR

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

Drug: 3. Treatment with ibuprofen.

4

PLACEBO COMPARATOR

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

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

Interventions

Treatment with fluconazole. DRUG

1

2. Treatment with both fluconazole and Ibuprofen. DRUG

2

3. Treatment with ibuprofen. DRUG

3

4. No treatment with either fluconazole nor ibuprofen. OTHER

4

Eligibility Criteria

• Age: 23 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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.
• Parents that are in command of the Swedish language and capable of understanding the study plan
• Informed written parental consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anders Rane, MD, PhD, Senior professor: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Neonatal Intensive Care Unit, Karolinska University Hopsital

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Bacterial Infections and Mycoses

Interventions

Therapeutics; Fluconazole; Ibuprofen

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Anders Rane, Prof. MD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior professor

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 5, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

SE (1)