Very Low Birth Weight InfantPhase 2NCT01851954
Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)
A Phase 2 study testing Clarithromycin in people with Very Low Birth Weight Infant and Ureaplasma/Mycoplasma Positive, 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 clarithromycin which is used for premature infants with ureaplasma. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Very Low Birth Weight Infant, Ureaplasma/Mycoplasma Positive
- What is being tested?
- Clarithromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Apr 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 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birthweight < 1500gm or GA < 32 weeks
- transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)
Who cannot join
- sepsis, hypotension, shock
- major congenital anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation
The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.
- Being tested
- Clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
IV clarithromycin infusion
| Study group | Role | What they receive |
|---|---|---|
| clarithromycin | Experimental | Population PK Receives: Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics
AUC, Cmax
Measured: 72 hours after first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: declined enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851954
- Sponsor's protocol ID
- clarith_VLBW
- Status last verified
- Nov 2014
- First submitted
- 12 Apr 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 Clarithromycin in Premature Infants With Safety Evaluation
- ClinicalTrials.gov ID
- NCT01851954
- Acronym / sponsor ID
- clarith_VLBW
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: declined enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 May 2013 (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 clarithromycin which is used for premature infants with ureaplasma.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clarithromycin | Experimental | Drug: ClarithromycinPopulation PK |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- birthweight < 1500gm or GA < 32 weeks
- transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)
Key exclusion criteria (2 listed)
- sepsis, hypotension, shock
- major congenital anomaly
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 |
|---|---|---|
| ClarithromycinIV clarithromycin infusion | Drug | clarithromycin |
Primary outcome
pharmacokinetics
Time frame: 72 hours after first infusion
AUC, Cmax
Results and safety
The study was stopped early (reason given: declined enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
Related trials for Very Low Birth Weight Infant
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Premature Infant, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Recruiting
Donor Breast Milk 2
Iron Deficiency Anemia
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 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 Clarithromycin in people with Very Low Birth Weight Infant and Ureaplasma/Mycoplasma Positive, 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 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: stopped early, 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 was stopped early (reason given: declined enrollment). Results are not available in the source record.
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?
pharmacokinetics (time frame: 72 hours after first infusion). 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 19 Nov 2014.