MRSA InfectionNCT01724671
Vancomycin Versus Ceftaroline in Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline
An observational study of MRSA Infection and Bacteremia, run by CPL Associates at 1 site in United States.
Trial summary
To compare the time to pathogen eradication, and the relationship to the time to clinical improvement, between ceftaroline and case-matched vancomycin treated controls in the treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus aureus (MRSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA Infection, Bacteremia, ABSSSI
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators will retrospectively capture patient cases that have been treated for MRSA with ceftaroline, either in response to cultures or empirically with subsequent discovery of MRSA. Cases will only be included if the isolate was tested against vancomycin and ceftaroline, unless the isolate is available in the microbiology lab to send to the study coordinating center for subsequent testing of minimum inhibitory concentrations (MIC). Case matched patients treated with vancomycin will also be collected as the control group.
Who may be able to join
- A positive MRSA culture, resulting from a blood or properly obtained infection site sample, with a vancomycin MIC 1.5 - 4.0 mcg/mL and ceftaroline MIC ≤1 mcg/mL.
- The patient was treated adequately with ceftaroline or vancomycin.
- A medical history, clinical signs and symptoms, and radiological findings consistent with infection such as pneumonia, skin and wound, intra-abdominal infection and bacteremia associated with one of those infection sites.
- Patients must have had a body temperature >38C [100.4F] or <36.1C [97F] or leukocytosis (blood leukocyte count >10,000 cells/mm3) or >10% bands, at baseline. In the case of pneumonia, chest radiographic examination that show a new or progressive infiltrate, consolidation, cavitation, or pleural effusion. Rales or dullness to percussion on physical examination of the chest, new onset of purulent sputum, or change in quantity or character of sputum. Wound redness, swelling, and/or purulence in the case of ABSSSI
- There should be sufficient numbers of follow up cultures of the infection site and/or blood to determine whether the infecting pathogen was eradicated, and preferably the day on which the eradication occurred.
- Additional inclusion criteria for patients with pneumonia:
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- Suspected or confirmed acute bacterial pneumonia due to MRSA in one of the following subgroups:
- Community-acquired bacterial pneumonia (CABP) i.e. those cases acquired outside the hospital and being admitted to the hospital for treatment of their pneumonia;
- or
- Hospital-acquired bacterial pneumonia (HABP), i.e., pneumonia that occurs 72 hours or more after admission, which was not incubating at the time of admission;
- or
- Ventilator-associated bacterial pneumonia (VABP), i.e., pneumonia that arises more than 48 hours after endotracheal intubation and ventilation;
- or
- Health Care-associated bacterial pneumonia (HCABP), which includes patients admitted from a long term care facility.
- Pulmonary infiltration consistent with the diagnosis of pneumonia (new or progressive infiltrates, consolidation, with or without the presence of pleural effusion) documented by chest X-ray or CT within 48 hours prior to enrollment.
- Suitable respiratory specimen (sputum/endotracheal specimen or specimen from an invasive procedure) for culture and Gram stain, with Gram-positive pathogens as the predominant organism. Average of at least 10 Gram-positive organisms per oil-immersion field in 10 fields (actual or calculated, 100x objective).
- Additional inclusion criteria for patients with other infection sites:
- In all cases of bacteremia linked to a site/source, the isolate species and susceptibility should match between blood and primary site. Typical non-pneumonia sites of infection will include complicated intra-abdominal (cIAI) and ABSSSI.
- In contrast, bacteremic patients with IV catheter as the only source will require that the catheter was removed/replaced, and yet the patient remains culture positive for at least 24 hr after replacement of the catheter.
Who cannot join
- Age <18 years
- Pregnant or lactating women
- Life expectancy <3 months from underlying disease
- Infection with Mycobacterium tuberculosis
- Organism is not available or is not tested locally for MIC to ceftaroline or vancomycin
- Bacteremia determined to be catheter-related with no definitive evidence of a secondary source
- Patient is on a prior antibiotic and shows clinical improvement or negative cultures before treatment of ceftaroline (or vancomycin for control patients).
Trial locations and contacts
1 site in 1 country.
United States1 site
Erie County Medical Center
Buffalo, New York, 14215
Joseph Paladino, Pharm.D., 716-633-3330 ext. 202, jpaladino@cplassociates.com
Joseph Paladino, Pharm.D.
About this study
Official title: A Case Series of Ceftaroline-treated Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline, Compared to Vancomycin-treated Patients
To compare the time to pathogen eradication, and the relationship to the time to clinical improvement, between ceftaroline and case-matched vancomycin treated controls in the treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus aureus (MRSA).
- Conditions
- MRSA Infection, Bacteremia, ABSSSI, Pneumonia
- Keywords
- MRSA, Bacteremia, ABSSSI, Pneumonia, Vancomycin, Ceftaroline
- Medical subject headings
- Bacteremia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cefatroline | Investigators will retrospectively capture patient cases that have been treated for MRSA with ceftaroline. Cases will only be included if the isolate was tested against vancomycin and ceftaroline | |
| Vancomycin | Investigators will retrospectively capture patient cases that were been treated for MRSA with Vancomycin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Eradication
Time to eradication of bacteria from the infection site and/or blood in relation to time to clinical improvement. For Acute Bacterial Skin and Skin Structure Infections (ABSSSI), it is recognized that wound cultures may not be repeated often, so the focus will be on the monitoring of time to clinical resolution in conjunction with time to resolve the bacteremic phase, if bacteremia is present.
Measured: 10 days
Secondary outcomes (1)
Test of Cure
Secondary Efficacy endpoint (Cure, Failure or Indeterminate) will also be assessed at the Test of Cure, 7-10 days after last dose.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSA InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CPL Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Jerome Schentag, CPL Associates
- Investigators
- Jerome J Schentag, Pharm.D., Principal investigator, State University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724671
- Sponsor's protocol ID
- CPLA 6656
- Status last verified
- Nov 2012
- First submitted
- 5 Nov 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series of Ceftaroline-treated Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline, Compared to Vancomycin-treated Patients
- ClinicalTrials.gov ID
- NCT01724671
- Acronym / sponsor ID
- CPLA 6656
- Conditions
- MRSA Infection, Bacteremia, ABSSSI, Pneumonia
- Keywords
- MRSA, Bacteremia, ABSSSI, Pneumonia, Vancomycin, Ceftaroline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CPL AssociatesUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 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.
To compare the time to pathogen eradication, and the relationship to the time to clinical improvement, between ceftaroline and case-matched vancomycin treated controls in the treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus aureus (MRSA).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefatroline | – | –Investigators will retrospectively capture patient cases that have been treated for MRSA with ceftaroline. Cases will only be included if the isolate was tested against vancomycin and ceftaroline |
| Vancomycin | – | –Investigators will retrospectively capture patient cases that were been treated for MRSA with Vancomycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators will retrospectively capture patient cases that have been treated for MRSA with ceftaroline, either in response to cultures or empirically with subsequent discovery of MRSA. Cases will only be included if the isolate was tested against vancomycin and ceftaroline, unless the isolate is available in the microbiology lab to send to the study coordinating center for subsequent testing of minimum inhibitory concentrations (MIC). Case matched patients treated with vancomycin will also be collected as the control group.
Key inclusion criteria (19 listed)
- A positive MRSA culture, resulting from a blood or properly obtained infection site sample, with a vancomycin MIC 1.5 - 4.0 mcg/mL and ceftaroline MIC ≤1 mcg/mL.
- The patient was treated adequately with ceftaroline or vancomycin.
- A medical history, clinical signs and symptoms, and radiological findings consistent with infection such as pneumonia, skin and wound, intra-abdominal infection and bacteremia associated with one of those infection sites.
- Patients must have had a body temperature >38C [100.4F] or <36.1C [97F] or leukocytosis (blood leukocyte count >10,000 cells/mm3) or >10% bands, at baseline. In the case of pneumonia, chest radiographic examination that show a new or progressive infiltrate, consolidation, cavitation, or pleural effusion. Rales or dullness to percussion on physical examination of the chest, new onset of purulent sputum, or change in quantity or character of sputum. Wound redness, swelling, and/or purulence in the case of ABSSSI
- There should be sufficient numbers of follow up cultures of the infection site and/or blood to determine whether the infecting pathogen was eradicated, and preferably the day on which the eradication occurred.
Key exclusion criteria (7 listed)
- Age <18 years
- Pregnant or lactating women
- Life expectancy <3 months from underlying disease
- Infection with Mycobacterium tuberculosis
- Organism is not available or is not tested locally for MIC to ceftaroline or vancomycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial Eradication
Time frame: 10 days
Time to eradication of bacteria from the infection site and/or blood in relation to time to clinical improvement. For Acute Bacterial Skin and Skin Structure Infections (ABSSSI), it is recognized that wound cultures may not be repeated often, so the focus will be on the monitoring of time to clinical resolution in conjunction with time to resolve the bacteremic phase, if bacteremia is present.
1 secondary outcome
Test of Cure
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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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.
Jerome J Schentag, Pharm.D. principal investigator
State University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MRSA Infection and Bacteremia, run by CPL Associates at 1 site in United States.
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 19 inclusion and 7 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 12 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 United States. 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 Jerome J Schentag, Pharm.D (716-633-3330 ext. 204, jschentag@cplassociates.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Eradication (time frame: 10 days). 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 12 Nov 2012.