Ductus Arteriosis, PatentPhase 4NCT02079298
Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants
A Phase 4 study testing Treatment with fluconazole., 2. Treatment with both fluconazole and Ibuprofen. and 3. Treatment with ibuprofen. in people with Ductus Arteriosis, Patent and Bacterial Infections and Mycoses, run by Anders Rane, MD, PhD, Senior professor at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 42 weeks
- Conditions the study is for
- Ductus Arteriosis, Patent, Bacterial Infections and Mycoses
- What is being tested?
- Treatment with fluconazole., 2. Treatment with both fluconazole and Ibuprofen. and 3. Treatment with ibuprofen.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Neonatal Intensive Care Unit, Karolinska University Hopsital
Stockholm, 171 76
About this study
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
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.
Read the 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.
- Being tested
- Treatment with fluconazole., 2. Treatment with both fluconazole and Ibuprofen., 3. Treatment with ibuprofen., 4. No treatment with either fluconazole nor ibuprofen.
- Medical subject headings
- Bacterial Infections and Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with fluconazole.Drug
2. Treatment with both fluconazole and Ibuprofen.Drug
3. Treatment with ibuprofen.Drug
4. No treatment with either fluconazole nor ibuprofen.Other
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole. Receives: 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. Receives: 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. Receives: 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. Receives: Other: 4. No treatment with either fluconazole nor ibuprofen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 5 days
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductus Arteriosis, PatentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Rane, MD, PhD, Senior professor
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Anders Rane, MD, PhD, Senior professor, Karolinska Institutet
- Investigators
- Anders Rane, Prof. MD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079298
- Sponsor's protocol ID
- EudraCT number: 2013-003611-21
- Status last verified
- Sep 2015
- First submitted
- 26 Feb 2014
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02079298
- Acronym / sponsor ID
- EudraCT number: 2013-003611-21
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Anders Rane, MD, PhD, Senior professorUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Treatment with fluconazole.Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated only with fluconazole. |
| 2 | Active comparator | Drug: 2. Treatment with both fluconazole and Ibuprofen.Premature newborn infants with Gestational Age 23+0 to 26+6 weeks who are treated with both fluconazole and Ibuprofen. |
| 3 | Active comparator | Drug: 3. Treatment with ibuprofen.Premature newborn infants with Gestational Age 27+0 to 36+6 who are treated only with ibuprofen. |
| 4 | Placebo comparator | Other: 4. No treatment with either fluconazole nor ibuprofen.Premature newborn infants with Gestational Age 27+0 to 36+6 and fullterm infants who are not treated either with fluconazole or ibuprofen. |
Who may qualify
- Ages
- 23 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter.
Time frame: 5 days
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.
2 secondary outcomes
Concentration of thromboxane A2 (TXA2) and prostacycline (PGI2) in relation to genetic variation of the enzymes of the Cytochrome (P4502C) family.
Time frame: 5 days
Number of and type of Adverse Drug Reactions
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Rane, Prof. MD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment with fluconazole., 2. Treatment with both fluconazole and Ibuprofen. and 3. Treatment with ibuprofen. in people with Ductus Arteriosis, Patent and Bacterial Infections and Mycoses, run by Anders Rane, MD, PhD, Senior professor at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary concentrations of prostacycline (PGI2) and thromboxane A2 (TxA2) measured in picogram/milliliter. (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.