Very Low Birth Weight InfantPhase 2NCT01683760
Pharmacokinetic Study of Fluconazole in Premature Infants
A Phase 2 study testing Fluconazole in people with Very Low Birth Weight Infant, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- Fluconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Oct 2014
- Phase
- Phase 2
- 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 Up to 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- very low birth weight infant (birth weight < 1,500 g) who were admitted to the NICU before day 3 of life
- Informed consent from the parents
Who cannot join
- Major congenital anomaly
- Expired within 72 hours of life
- Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher)
- Proven congenital or intrauterine fungal infection
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- Fluconazole
- Keywords
- Fluconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Prophylactic fluconazole administration in VLBW infants
| Study group | Role | What they receive |
|---|---|---|
| Population PK | Experimental | Not described Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug level of fluconazole
four times drug level after 3th dose
Measured: 30min later, 10-12hr later, at routine lab with interval of 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Suk Kim, Seoul National University Hospital
- Investigators
- Han-Suk Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683760
- Sponsor's protocol ID
- FLU_PK
- Other IDs
- 12172_231
- Status last verified
- Nov 2014
- First submitted
- 9 Sep 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim YK, Lee J, Oh J, Rhee SJ, Shin SH, Yoon SH, Lee S, Kim HS, Yu KS. Population Pharmacokinetic Study of Prophylactic Fluconazole in Preterm Infants for Prevention of Invasive Candidiasis. Antimicrob Agents Chemother. 2019 May 24;63(6):e01960-18. doi: 10.1128/AAC.01960-18. Print 2019 Jun.
PubMed 30910892
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Fluconazole in Premature Infants
- ClinicalTrials.gov ID
- NCT01683760
- Acronym / sponsor ID
- FLU_PK
- Conditions
- Very Low Birth Weight Infant
- Keywords
- Fluconazole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Sep 2012 (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.
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population PK | Experimental | Drug: Fluconazole |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- very low birth weight infant (birth weight < 1,500 g) who were admitted to the NICU before day 3 of life
- Informed consent from the parents
Key exclusion criteria (4 listed)
- Major congenital anomaly
- Expired within 72 hours of life
- Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher)
- Proven congenital or intrauterine fungal infection
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 |
|---|---|---|
| FluconazoleProphylactic fluconazole administration in VLBW infants | Drug | Population PK |
Primary outcome
drug level of fluconazole
Time frame: 30min later, 10-12hr later, at routine lab with interval of 1week
four times drug level after 3th dose
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 19 Nov 2014.
- Derived from this study: PubMed 30910892Kim YK, Lee J, Oh J, Rhee SJ, Shin SH, Yoon SH, Lee S, Kim HS, Yu KS. Population Pharmacokinetic Study of Prophylactic Fluconazole in Preterm Infants for Prevention of Invasive Candidiasis. Antimicrob Agents Chemother. 2019 May 24;63(6):e01960-18. doi: 10.1128/AAC.01960-18. Print 2019 Jun.
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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.
Han-Suk Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluconazole in people with Very Low Birth Weight Infant, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 4 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 19 Nov 2014. 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 South Korea. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
drug level of fluconazole (time frame: 30min later, 10-12hr later, at routine lab with interval of 1week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683760, which also lists 1 linked publication.
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 19 Nov 2014.