Vancomycin Versus Ceftaroline in Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by CPL Associates
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Jerome Schentag, CPL Associates
ClinicalTrials.gov Identifier:
NCT01724671
First received: November 5, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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).


Condition
MRSA Infection
Bacteremia
ABSSSI
Pneumonia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Case Series of Ceftaroline-treated Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline, Compared to Vancomycin-treated Patients

Resource links provided by NLM:


Further study details as provided by CPL Associates:

Primary Outcome Measures:
  • Bacterial Eradication [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Test of Cure [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Secondary Efficacy endpoint (Cure, Failure or Indeterminate) will also be assessed at the Test of Cure, 7-10 days after last dose.


Biospecimen Retention:   Samples Without DNA

MRSA cultures obtained retrospectively from Microbiology labs if available for patients.


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  1. 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.
  2. The patient was treated adequately with ceftaroline or vancomycin.
  3. 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

  4. 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:

  1. 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.

  2. 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.
  3. 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:

  1. 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.
  2. 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.

Exclusion Criteria

  1. Age <18 years
  2. Pregnant or lactating women
  3. Life expectancy <3 months from underlying disease
  4. Infection with Mycobacterium tuberculosis
  5. Organism is not available or is not tested locally for MIC to ceftaroline or vancomycin
  6. Bacteremia determined to be catheter-related with no definitive evidence of a secondary source
  7. Patient is on a prior antibiotic and shows clinical improvement or negative cultures before treatment of ceftaroline (or vancomycin for control patients).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724671

Contacts
Contact: Jerome J Schentag, Pharm.D 716-633-3330 ext 204 jschentag@cplassociates.com
Contact: Joseph Paladino, Pharm.D. 716-633-3330 ext 202 jpaladino@cplassociates.com

Locations
United States, New York
Erie County Medical Center Not yet recruiting
Buffalo, New York, United States, 14215
Contact: Joseph Paladino, Pharm.D.    716-633-3330 ext 202    jpaladino@cplassociates.com   
Principal Investigator: Joseph Paladino, Pharm.D.         
Sponsors and Collaborators
CPL Associates
Forest Laboratories
Investigators
Principal Investigator: Jerome J Schentag, Pharm.D. State University at Buffalo
  More Information

No publications provided

Responsible Party: Jerome Schentag, Pharm.D., CPL Associates
ClinicalTrials.gov Identifier: NCT01724671     History of Changes
Other Study ID Numbers: CPLA 6656
Study First Received: November 5, 2012
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CPL Associates:
MRSA
Bacteremia
ABSSSI
Pneumonia
Vancomycin
Ceftaroline

Additional relevant MeSH terms:
Bacteremia
Pneumonia
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014