Infections Requiring Prolonged Duration (>10 Days) of VancomycinNCT01720940
Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin
A study testing continuous vancomycin infusion and intermittent vancomycin infusion in people with Infections Requiring Prolonged Duration (>10 Days) of Vancomycin, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion. This study will recruit 220 subjects from 2 hospitals over a period of 3 years. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Infections Requiring Prolonged Duration (>10 Days) of Vancomycin
- What is being tested?
- continuous vancomycin infusion and intermittent vancomycin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2012to Sep 2015
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 21-80 years
- Documented infection requiring prolonged (> 10 days) of vancomycin therapy
- Creatinine clearance > 50 ml/min (using Cockroft-Gault equation)
Who cannot join
- Patient already received 7 days or more of vancomycin therapy
- Pregnancy
- Severe burns > 40% body surface area
- Spinal cord injuries
- Participation in another interventional trial in previous 30 days
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Shire Yang Tan, 97989001, shire_yang_tan@nuhs.edu.sg
Dale Fisher
About this study
Official title: Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin
This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion.
This study will recruit 220 subjects from 2 hospitals over a period of 3 years.
Participants are invited if they have an infection that requires prolonged vancomycin therapy (> more than 10 days).
- Being tested
- continuous vancomycin infusion, intermittent vancomycin infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous vancomycin infusionDrug
24-hour continuous infusion of vancomycin
intermittent vancomycin infusionDrug
| Study group | Role | What they receive |
|---|---|---|
| continuous vancomycin infusion | Experimental | Not described Receives: Drug: continuous vancomycin infusion |
| intermittent vancomycin infusion | Active comparator | vancomycin in this arm will be administered as intermittent infusion Receives: Drug: intermittent vancomycin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
nephrotoxicity
nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria
Measured: occurring any time while on vancomycin treatment up to 14 days post treatment completion
Secondary outcomes (1)
biomarkers for detection of early nephrotoxicity
serum and urine NGAL and cystatin C
Measured: measured weekly from the date of randomization until 14 days post completion of vancomycin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections Requiring Prolonged Duration (>10 Days) of VancomycinStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720940
- Sponsor's protocol ID
- NUHID-001
- Status last verified
- Nov 2012
- First submitted
- 21 Oct 2012
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin
- ClinicalTrials.gov ID
- NCT01720940
- Acronym / sponsor ID
- NUHID-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital
- Study start
- Oct 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 2 Nov 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.
This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion.
This study will recruit 220 subjects from 2 hospitals over a period of 3 years.
Participants are invited if they have an infection that requires prolonged vancomycin therapy (> more than 10 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous vancomycin infusion | Experimental | Drug: continuous vancomycin infusion |
| intermittent vancomycin infusion | Active comparator | Drug: intermittent vancomycin infusionvancomycin in this arm will be administered as intermittent infusion |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 21-80 years
- Documented infection requiring prolonged (> 10 days) of vancomycin therapy
- Creatinine clearance > 50 ml/min (using Cockroft-Gault equation)
Key exclusion criteria (6 listed)
- Patient already received 7 days or more of vancomycin therapy
- Pregnancy
- Severe burns > 40% body surface area
- Spinal cord injuries
- Participation in another interventional trial in previous 30 days
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 vancomycin infusion24-hour continuous infusion of vancomycin | Drug | continuous vancomycin infusion |
| intermittent vancomycin infusion | Drug | intermittent vancomycin infusion |
Primary outcome
nephrotoxicity
Time frame: occurring any time while on vancomycin treatment up to 14 days post treatment completion
nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria
1 secondary outcome
biomarkers for detection of early nephrotoxicity
Time frame: measured weekly from the date of randomization until 14 days post completion of vancomycin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous vancomycin infusion and intermittent vancomycin infusion in people with Infections Requiring Prolonged Duration (>10 Days) of Vancomycin, run by National University Hospital, Singapore at 1 site in Singapore.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Nov 2012. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shire Yang Tan (97989001, shire_yang_tan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nephrotoxicity (time frame: occurring any time while on vancomycin treatment up to 14 days post treatment completion). 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 Nov 2012.