Blood Stream InfectionsToPICLNCT00990392
Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections
A study testing Polysporin Triple Therapy ointment and Petroleum Jelly in people with Blood Stream Infections and Skin Diseases, Infectious, run by Fraser Health at 1 site in Canada.
Trial summary
The purpose of the study is to determine if the overall central venous catheter related infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the insertion site. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Stream Infections, Skin Diseases, Infectious
- What is being tested?
- Polysporin Triple Therapy ointment and Petroleum Jelly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Jan 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients admitted to the ICU requiring a central venous catheter
Who cannot join
- previous line infection during same ICU stay
- CVC for hemodialysis
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian Hospital
New Westminster, British Columbia, V3L 1A1
About this study
Official title: Pilot Study: Topical Antibiotics for Prevention of ICU Central Line Infections
The purpose of the study is to determine if the overall central venous catheter related infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the insertion site.
Read the detailed description
Previous studies in the dialysis population have found a reduction in local and system central venous catheter related infections with the application of topical antibiotics to the insertion point. One such study found a mortality benefit with Polysporin Triple Therapy ointment. We intend to determine if this preparation can reduce overall line infection rates in the ICU environment through its application at the time of line insertion and twice more the following week.
- Conditions
- Blood Stream Infections, Skin Diseases, Infectious
- Being tested
- Polysporin Triple Therapy ointment, Petroleum Jelly
- Keywords
- Blood stream infections, Catheter related infections, Central venous catheter related infections, Line sepsis, Topical antibiotics, Bacitracin, Polymixin, Gramicidin, Polysporin Triple Therapy, Intensive care unit
- Medical subject headings
- Skin Diseases, Infectious, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysporin Triple Therapy ointmentDrug
Also called Polysporin Triple Therapy (gramicidin, polymixin, bacitracin)
Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.
Petroleum JellyOther
Also called Vaseline
Petroleum jelly applied to the insertion point at the time of CVC placement and twice within the first week.
| Study group | Role | What they receive |
|---|---|---|
| Polysporin Triple Therapy | Experimental | Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week. Receives: Drug: Polysporin Triple Therapy ointment |
| Placebo | Placebo comparator | Petroleum jelly Receives: Other: Petroleum Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall number of line related infections (local and blood borne)
Measured: 6 months
Secondary outcomes (3)
Length of ICU stay
Measured: 7 months
Length of hospital stay
Measured: 7 months
Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Change of practice to antibiotic impregnated catheters and large study published showing their efficacy. Made topical antibiotics obselete.
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 Blood Stream 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Reynolds, Fraser Health
- Investigators
- Steven Reynolds, MD, Principal investigator, Fraser Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990392
- Sponsor's protocol ID
- Kerrie-333333
- Acronym
- ToPICL
- Status last verified
- May 2015
- First submitted
- 5 Oct 2009
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lok CE, Stanley KE, Hux JE, Richardson R, Tobe SW, Conly J. Hemodialysis infection prevention with polysporin ointment. J Am Soc Nephrol. 2003 Jan;14(1):169-79. doi: 10.1097/01.asn.0000038688.76195.a4.
PubMed 12506149James MT, Conley J, Tonelli M, Manns BJ, MacRae J, Hemmelgarn BR; Alberta Kidney Disease Network. Meta-analysis: antibiotics for prophylaxis against hemodialysis catheter-related infections. Ann Intern Med. 2008 Apr 15;148(8):596-605. doi: 10.7326/0003-4819-148-8-200804150-00004.
PubMed 18413621
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Topical Antibiotics for Prevention of ICU Central Line Infections
- ClinicalTrials.gov ID
- NCT00990392
- Acronym / sponsor ID
- ToPICL / Kerrie-333333
- Conditions
- Blood Stream Infections, Skin Diseases, Infectious
- Keywords
- Blood stream infections, Catheter related infections, Central venous catheter related infections, Line sepsis, Topical antibiotics, Bacitracin, Polymixin, Gramicidin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of practice to antibiotic impregnated catheters and large study published showing their efficacy. Made topical antibiotics obselete.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Oct 2009 (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 the study is to determine if the overall central venous catheter related infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the insertion site.
Detailed description
Previous studies in the dialysis population have found a reduction in local and system central venous catheter related infections with the application of topical antibiotics to the insertion point. One such study found a mortality benefit with Polysporin Triple Therapy ointment. We intend to determine if this preparation can reduce overall line infection rates in the ICU environment through its application at the time of line insertion and twice more the following week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polysporin Triple Therapy | Experimental | Drug: Polysporin Triple Therapy ointmentPolysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week. |
| Placebo | Placebo comparator | Other: Petroleum JellyPetroleum jelly |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients admitted to the ICU requiring a central venous catheter
Key exclusion criteria (2 listed)
- previous line infection during same ICU stay
- CVC for hemodialysis
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 |
|---|---|---|
| Polysporin Triple Therapy ointmentAlso: Polysporin Triple Therapy (gramicidin, polymixin, bacitracin)Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week. | Drug | Polysporin Triple Therapy |
| Petroleum JellyAlso: VaselinePetroleum jelly applied to the insertion point at the time of CVC placement and twice within the first week. | Other | Placebo |
Primary outcome
Overall number of line related infections (local and blood borne)
Time frame: 6 months
3 secondary outcomes
Length of ICU stay
Time frame: 7 months
Length of hospital stay
Time frame: 7 months
Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Background: PubMed 12506149Lok CE, Stanley KE, Hux JE, Richardson R, Tobe SW, Conly J. Hemodialysis infection prevention with polysporin ointment. J Am Soc Nephrol. 2003 Jan;14(1):169-79. doi: 10.1097/01.asn.0000038688.76195.a4.
- Background: PubMed 18413621James MT, Conley J, Tonelli M, Manns BJ, MacRae J, Hemmelgarn BR; Alberta Kidney Disease Network. Meta-analysis: antibiotics for prophylaxis against hemodialysis catheter-related infections. Ann Intern Med. 2008 Apr 15;148(8):596-605. doi: 10.7326/0003-4819-148-8-200804150-00004.
Related trials for Blood Stream Infections
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruitingObservational study
Antimicrobial Resistance and Genomic Profiling of Bacterial Isolates
Blood Stream Infections, Adult Cancer Patients
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
RecruitingObservational study
Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)
Hepatitis B, Chronic
RecruitingObservational study
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
Blood Stream Infection, Blood Stream Infections
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.
Steven Reynolds, MD principal investigator
Fraser Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysporin Triple Therapy ointment and Petroleum Jelly in people with Blood Stream Infections and Skin Diseases, Infectious, 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 1 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: withdrawn, as of the sponsor's last update on 29 May 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall number of line related infections (local and blood borne) (time frame: 6 months). 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 NCT00990392, 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 29 May 2015.