SepsisNCT02210169
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
A study testing Continuous infusion of vancomycin in people with Sepsis and Infection, run by Murdoch Childrens Research Institute at 2 sites in Australia.
Trial summary
Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over 1 hour) or as a continuous infusion (over 24 hours). Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Sepsis, Infection, Bacteremia
- What is being tested?
- Continuous infusion of vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesAustralia
- Study dates
- Sep 2014to May 2018
- Phase
- Interventional
- 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 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.
Who cannot join
- Infants with a corrected gestational age < 25 weeks.
- Allergy to vancomycin or other glycopeptide antibiotic
- Vancomycin administered within the previous 72 hours
- Renal impairment
- Prior enrolment in the study
- Need for drug that is incompatible with vancomycin (if no other IV line is available)
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
The Royal Children's Hospital
Melbourne, Victoria, 3052
Royal Hospital for Women
Sydney, New South Wales, 2031
About this study
Official title: A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates
Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over 1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering vancomycin as a continuous infusion will result in improved attainment of target concentrations in blood at steady state (when the drug is in equilibrium) compared to intermittent infusion.
- Conditions
- Sepsis, Infection, Bacteremia
- Being tested
- Continuous infusion of vancomycin
- Medical subject headings
- Sepsis, Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous infusion of vancomycinDrug
Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent infusion of vancomycin | No intervention | Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age. |
| Continuous infusion of vancomycin | Active comparator | A loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period. Receives: Drug: Continuous infusion of vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
Measured: 2 years
Secondary outcomes (6)
Drug-related adverse effects
the proportion of drug-related adverse effects with CIV compared to IIV
Measured: 2 years
Time to achieve target levels
the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood
Measured: 2 years
Clearance of vancomycin in young infants
Population pharmacokinetic modelling of vancomycin in young infants using NONMEM
Measured: 2 years
Volume of distribution of vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Measured: 2 years
Area under the concentration-time curve of vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Measured: 2 years
Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital, Royal Hospital For Women
- Responsible party
- Sponsor
- Investigators
- Amanda Gwee, MBBS, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210169
- Sponsor's protocol ID
- Vanc_IIV vs CIV
- Status last verified
- Oct 2018
- First submitted
- 5 Aug 2014
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gwee A, Cranswick N, McMullan B, Perkins E, Bolisetty S, Gardiner K, Daley A, Ward M, Chiletti R, Donath S, Hunt R, Curtis N. Continuous Versus Intermittent Vancomycin Infusions in Infants: A Randomized Controlled Trial. Pediatrics. 2019 Feb;143(2):e20182179. doi: 10.1542/peds.2018-2179.
PubMed 30700564Gwee A, Cranswick N, Donath SM, Hunt R, Curtis N. Protocol for a randomised controlled trial of continuous infusions of vancomycin to improve the attainment of target vancomycin levels in young infants: The VANC trial. BMJ Open. 2018 Nov 3;8(11):e022603. doi: 10.1136/bmjopen-2018-022603.
PubMed 30391914
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates
- ClinicalTrials.gov ID
- NCT02210169
- Acronym / sponsor ID
- Vanc_IIV vs CIV
- Conditions
- Sepsis, Infection, Bacteremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Royal Children's Hospital, Royal Hospital For Women
- Study start
- Sep 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 6 Aug 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.
Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over 1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering vancomycin as a continuous infusion will result in improved attainment of target concentrations in blood at steady state (when the drug is in equilibrium) compared to intermittent infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent infusion of vancomycin | No intervention | –Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age. |
| Continuous infusion of vancomycin | Active comparator | Drug: Continuous infusion of vancomycinA loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period. |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.
Key exclusion criteria (6 listed)
- Infants with a corrected gestational age < 25 weeks.
- Allergy to vancomycin or other glycopeptide antibiotic
- Vancomycin administered within the previous 72 hours
- Renal impairment
- Prior enrolment in the study
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 |
|---|---|---|
| Continuous infusion of vancomycinContinuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period. | Drug | Continuous infusion of vancomycin |
Primary outcome
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
Time frame: 2 years
6 secondary outcomes
Drug-related adverse effects
Time frame: 2 years
Time to achieve target levels
Time frame: 2 years
Clearance of vancomycin in young infants
Time frame: 2 years
Volume of distribution of vancomycin in young infants
Time frame: 2 years
Area under the concentration-time curve of vancomycin in young infants
Time frame: 2 years
Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
Time frame: 2 years
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 Nov 2018.
- Derived from this study: PubMed 30700564Gwee A, Cranswick N, McMullan B, Perkins E, Bolisetty S, Gardiner K, Daley A, Ward M, Chiletti R, Donath S, Hunt R, Curtis N. Continuous Versus Intermittent Vancomycin Infusions in Infants: A Randomized Controlled Trial. Pediatrics. 2019 Feb;143(2):e20182179. doi: 10.1542/peds.2018-2179.
- Derived from this study: PubMed 30391914Gwee A, Cranswick N, Donath SM, Hunt R, Curtis N. Protocol for a randomised controlled trial of continuous infusions of vancomycin to improve the attainment of target vancomycin levels in young infants: The VANC trial. BMJ Open. 2018 Nov 3;8(11):e022603. doi: 10.1136/bmjopen-2018-022603.
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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.
Amanda Gwee, MBBS principal investigator
Murdoch Childrens Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous infusion of vancomycin in people with Sepsis and Infection, run by Murdoch Childrens Research Institute at 2 sites in Australia.
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 1 inclusion and 6 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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.
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?
Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours) (time frame: 2 years). 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 NCT02210169, which also lists 2 linked publications.
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 Nov 2018.