Skin and Soft Tissue InfectionsVODNCT01037192
Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
A study testing vancomycin in people with Skin and Soft Tissue Infections, run by Fraser Health at 1 site in Canada.
Trial summary
Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Skin and Soft Tissue Infections
- What is being tested?
- vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 to 70 years
- Weight 40 - 80 kg
- Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated
- Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician
- Subject able to provide informed consent
Who cannot join
- Known history of allergy to vancomycin
- Pregnancy
- Granulocytopenia (< 1x109/L)
- Renal impairment (serum creatinine > 177 µmol/L or eGFR < 50 mL/min)
- Known history of vestibular disease or hearing loss
- Subjects treated with vancomycin within the previous month
- Subjects who have received more than 24 hours of vancomycin
- Subjects receiving other antimicrobials that cover MRSA (e.g. cotrimoxazole, rifampin, linezolid)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
About this study
Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.
- Conditions
- Skin and Soft Tissue Infections
- Being tested
- vancomycin
- Keywords
- outpatient, skin and soft tissue infections, vancomycin intravenous
- Medical subject headings
- Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycinDrug
vancomycin 30 mg/kg intravenous administered once daily
vancomycinDrug
vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)
| Study group | Role | What they receive |
|---|---|---|
| Vanco once daily | Experimental | Subject receives vancomycin 30 mg/kg dose Receives: Drug: vancomycin |
| Vanco twice daily | Active comparator | Subject receives vancomycin 15 mg/kg twice daily Receives: Drug: vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Efficacy
Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (> 15%) in leukocytes.
Measured: 5 days
Secondary outcomes (1)
Microbiological Efficacy
Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.
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 posted22 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin and Soft Tissue InfectionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Yuen, Fraser Health
- Investigators
- Anna Yuen, BSc. Pharm, Principal investigator, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037192
- Sponsor's protocol ID
- VOD
- Acronym
- VOD
- Status last verified
- Aug 2015
- First submitted
- 18 Dec 2009
- Last updated
- 27 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cohen E, Dadashev A, Drucker M, Samra Z, Rubinstein E, Garty M. Once-daily versus twice-daily intravenous administration of vancomycin for infections in hospitalized patients. J Antimicrob Chemother. 2002 Jan;49(1):155-60. doi: 10.1093/jac/49.1.155.
PubMed 11751780
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT01037192
- Acronym / sponsor ID
- VOD / VOD
- Conditions
- Skin and Soft Tissue Infections
- Keywords
- outpatient, skin and soft tissue infections, vancomycin intravenous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Dec 2009 (estimated)
- Results
- Posted 8 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanco once daily | Experimental | Drug: vancomycinSubject receives vancomycin 30 mg/kg dose |
| Vanco twice daily | Active comparator | Drug: vancomycinSubject receives vancomycin 15 mg/kg twice daily |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 19 to 70 years
- Weight 40 - 80 kg
- Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated
- Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician
- Subject able to provide informed consent
Key exclusion criteria (8 listed)
- Known history of allergy to vancomycin
- Pregnancy
- Granulocytopenia (< 1x109/L)
- Renal impairment (serum creatinine > 177 µmol/L or eGFR < 50 mL/min)
- Known history of vestibular disease or hearing loss
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 |
|---|---|---|
| vancomycinvancomycin 30 mg/kg intravenous administered once daily | Drug | Vanco once daily |
| vancomycinvancomycin 15 mg/kg intravenous administered twice daily (standard dosing) | Drug | Vanco twice daily |
Primary outcome
Clinical Efficacy
Time frame: 5 days
Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (> 15%) in leukocytes.
1 secondary outcome
Microbiological Efficacy
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 11751780Cohen E, Dadashev A, Drucker M, Samra Z, Rubinstein E, Garty M. Once-daily versus twice-daily intravenous administration of vancomycin for infections in hospitalized patients. J Antimicrob Chemother. 2002 Jan;49(1):155-60. doi: 10.1093/jac/49.1.155.
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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.
Anna Yuen, BSc. Pharm principal investigator
Fraser Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vancomycin in people with Skin and Soft Tissue Infections, run by Fraser Health at 1 site in Canada.
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 5 inclusion and 8 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 27 Aug 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 Canada. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Efficacy (time frame: 5 days). 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 NCT01037192, 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 27 Aug 2015; AzTrials last refreshed its copy on 1 Nov 2026.