Complicated Skin and Soft Tissue Infection
Conditions
Keywords
complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin
Brief summary
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
Detailed description
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
Interventions
IV ceftaroline 600mg every 8 hours
DRUGVancomycin
IV vancomycin 15mg/kg every 12 hours
DRUGAztreonam
IV aztreonam 1 g every 8 hours
Sponsors
Forest Laboratories
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18 years or older * Complicated skin and skin structure infection (cSSTI) * Infection of sufficient severity to warrant hospitalization * Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy
Exclusion criteria
* Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug * Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens * Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease * Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb * Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | 7 to 20 days after the last dose of study drug | The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. |
| Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set | 7 to 20 days after the last dose of study drug | The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at End of Treatment (EOT) in MITT Analysis Set | On day of last dose of study drug (or + 1 day) | The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. |
| Clinical Response at EOT in CE Analysis Set | On day of last dose of study drug (or +1 day) | The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline. |
| Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | 7 to 20 days after the last dose of study drug | Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. |
| Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | 48 to 72 hours after first dose of study drug | The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline. |
| Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | 7 to 20 days after the last dose of study drug | Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set |
| Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | 21 to 42 days after the last dose of study drug | The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC. |
| Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set | 7 to 20 days after the last dose of study drug | Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, China, Croatia, Czechia, France, Germany, Greece, Hong Kong, Israel, Italy, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Participant flow
Recruitment details
Overall, 802 patients were enrolled from 111 centres in 6 regions in this study. The first patient was enrolled on 17 May 2012 and the last patient last visit was on 26 June 2014. Of 802 enrolled participants, 30 did not meet the eligibility criteria and 11 were randomized but not treated.
Participants by arm
| Arm | Count |
|---|---|
| Ceftaroline Ceftaroline fosamil at 600 mg every 8 hours (q8h) | 506 |
| Vancomycin/Aztreonam Vancomycin Plus Aztreonam | 255 |
| Total | 761 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 6 |
| Overall Study | Death | 3 | 2 |
| Overall Study | Lack of therapeutic response and other | 8 | 7 |
| Overall Study | Lost to Follow-up | 15 | 8 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 16 | 6 |
Baseline characteristics
| Characteristic | Ceftaroline | Vancomycin/Aztreonam | Total |
|---|---|---|---|
| Age, Continuous | 52.6 Years STANDARD_DEVIATION 16.51 | 53.6 Years STANDARD_DEVIATION 16.25 | 52.9 Years STANDARD_DEVIATION 16.42 |
| Sex: Female, Male Female | 196 Participants | 107 Participants | 303 Participants |
| Sex: Female, Male Male | 310 Participants | 148 Participants | 458 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 82 / 506 | 46 / 255 |
| serious Total, serious adverse events | 31 / 506 | 15 / 255 |
Outcome results
Primary
Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Time frame: 7 to 20 days after the last dose of study drug
Population: Modified intent-to-treat (MITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | Clinical cure | 396 Participant |
| Ceftaroline | Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | Clinical failure | 58 Participant |
| Ceftaroline | Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | indeterminate | 52 Participant |
| Vancomycin/Aztreonam | Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | Clinical cure | 202 Participant |
| Vancomycin/Aztreonam | Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | Clinical failure | 34 Participant |
| Vancomycin/Aztreonam | Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set | indeterminate | 19 Participant |
Comparison: The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.95% CI: [-6.9, 5.41]
Primary
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Time frame: 7 to 20 days after the last dose of study drug
Population: Clinical evaluable (CE)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set | Clinical cure | 342 Participant |
| Ceftaroline | Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set | Clinical failure | 53 Participant |
| Vancomycin/Aztreonam | Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set | Clinical cure | 180 Participant |
| Vancomycin/Aztreonam | Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set | Clinical failure | 31 Participant |
Comparison: The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.95% CI: [-4.32, 7.48]
Secondary
Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.
Time frame: 21 to 42 days after the last dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | Relapse | 3 Participants |
| Ceftaroline | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | No relapse | 335 Participants |
| Ceftaroline | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | Indeterminate | 3 Participants |
| Ceftaroline | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | Missing | 1 Participants |
| Vancomycin/Aztreonam | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | Missing | 0 Participants |
| Vancomycin/Aztreonam | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | Relapse | 3 Participants |
| Vancomycin/Aztreonam | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | Indeterminate | 3 Participants |
| Vancomycin/Aztreonam | Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC | No relapse | 174 Participants |
95% CI: [-3.98, 1.18]
Secondary
Clinical Response at End of Treatment (EOT) in MITT Analysis Set
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Time frame: On day of last dose of study drug (or + 1 day)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | Clinical cure | 429 Participants |
| Ceftaroline | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | Clinical failure | 44 Participants |
| Ceftaroline | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | Indeterminate | 31 Participants |
| Ceftaroline | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | Missing | 2 Participants |
| Vancomycin/Aztreonam | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | Missing | 2 Participants |
| Vancomycin/Aztreonam | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | Clinical cure | 213 Participants |
| Vancomycin/Aztreonam | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | Indeterminate | 11 Participants |
| Vancomycin/Aztreonam | Clinical Response at End of Treatment (EOT) in MITT Analysis Set | Clinical failure | 29 Participants |
95% CI: [-4.05, 7.06]
Secondary
Clinical Response at EOT in CE Analysis Set
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Time frame: On day of last dose of study drug (or +1 day)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Clinical Response at EOT in CE Analysis Set | Clinical cure | 356 Participants |
| Ceftaroline | Clinical Response at EOT in CE Analysis Set | Clinical failure | 39 Participants |
| Vancomycin/Aztreonam | Clinical Response at EOT in CE Analysis Set | Clinical cure | 184 Participants |
| Vancomycin/Aztreonam | Clinical Response at EOT in CE Analysis Set | Clinical failure | 27 Participants |
95% CI: [-2.19, 8.73]
Secondary
Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.
Time frame: 48 to 72 hours after first dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | success | 445 Participants |
| Ceftaroline | Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | failure | 28 Participants |
| Ceftaroline | Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | Indeterminate | 33 Participants |
| Vancomycin/Aztreonam | Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | success | 229 Participants |
| Vancomycin/Aztreonam | Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | failure | 11 Participants |
| Vancomycin/Aztreonam | Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set | Indeterminate | 15 Participants |
95% CI: [-6.34, 3.15]
Secondary
Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set
Time frame: 7 to 20 days after the last dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | MSSA - Favorable; (n=94, 57) | 91 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Enterococcus faecalis - Unfavorable; (n=6, 5) | 1 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus pyogenes - Unfavorable; (n=15, 7) | 1 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Escherichia coli - Favorable; (n=12, 10) | 12 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | MRSA - Favorable; (n=25, 15) | 22 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Escherichia coli - Unfavorable; (n=12, 10) | 0 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus agalactiae - Favorable; (n=6, 9) | 6 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Klebsiella pneumoniae - Favorable; (n=7, 4) | 6 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Klebsiella oxytoca - Unfavorable; (n=4, 1) | 0 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Klebsiella pneumoniae - Unfavorable; (n=7, 4) | 1 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus agalactiae - Unfavorable; (n=6, 9) | 0 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | MRSA - Unfavorable; (n=25, 15) | 3 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Proteus mirabilis - Favorable; (n=7, 2) | 6 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus dysgalactiae - Favorable; (n=9, 0) | 9 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Proteus mirabilis - Unfavorable; (n=7, 2) | 1 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | MSSA - Unfavorable; (n=94, 57) | 3 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Morganella morganii - Favorable; (n=4, 2) | 4 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus dysgalactiae - Unfavorable; (n=9, 0) | 0 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Morganella morganii - Unfavorable; (n=4, 2) | 0 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus pyogenes - Favorable; (n=15, 7) | 14 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Enterobacter cloacae - Favorable; (n=4, 5) | 4 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Enterococcus faecalis - Favorable; (n=6, 5) | 5 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Enterobacter cloacae - Unfavorable; (n=4, 5) | 0 Participants |
| Ceftaroline | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Klebsiella oxytoca - Favorable; (n=4, 1) | 4 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Enterobacter cloacae - Unfavorable; (n=4, 5) | 0 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Klebsiella oxytoca - Favorable; (n=4, 1) | 1 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | MSSA - Favorable; (n=94, 57) | 49 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | MSSA - Unfavorable; (n=94, 57) | 8 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | MRSA - Favorable; (n=25, 15) | 12 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | MRSA - Unfavorable; (n=25, 15) | 3 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus pyogenes - Favorable; (n=15, 7) | 7 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus pyogenes - Unfavorable; (n=15, 7) | 0 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus agalactiae - Favorable; (n=6, 9) | 9 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus agalactiae - Unfavorable; (n=6, 9) | 0 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus dysgalactiae - Favorable; (n=9, 0) | 0 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Streptococcus dysgalactiae - Unfavorable; (n=9, 0) | 0 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Enterococcus faecalis - Favorable; (n=6, 5) | 4 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Enterococcus faecalis - Unfavorable; (n=6, 5) | 1 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Escherichia coli - Favorable; (n=12, 10) | 9 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Escherichia coli - Unfavorable; (n=12, 10) | 1 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Klebsiella pneumoniae - Favorable; (n=7, 4) | 3 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Klebsiella pneumoniae - Unfavorable; (n=7, 4) | 1 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Klebsiella oxytoca - Unfavorable; (n=4, 1) | 0 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Proteus mirabilis - Favorable; (n=7, 2) | 2 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Proteus mirabilis - Unfavorable; (n=7, 2) | 0 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Morganella morganii - Favorable; (n=4, 2) | 2 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Morganella morganii - Unfavorable; (n=4, 2) | 0 Participants |
| Vancomycin/Aztreonam | Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME | Enterobacter cloacae - Favorable; (n=4, 5) | 5 Participants |
Secondary
Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Time frame: 7 to 20 days after the last dose of study drug
Population: Microbiologically modified-intent-to-treat (mMITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | Favorable | 203 Participant |
| Ceftaroline | Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | Unfavorable | 17 Participant |
| Ceftaroline | Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | Indeterminate | 28 Participant |
| Vancomycin/Aztreonam | Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | Favorable | 109 Participant |
| Vancomycin/Aztreonam | Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | Unfavorable | 17 Participant |
| Vancomycin/Aztreonam | Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set | Indeterminate | 10 Participant |
95% CI: [-6.21, 10.39]
Secondary
Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Time frame: 7 to 20 days after the last dose of study drug
Population: Microbiologically evaluable (ME)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ceftaroline | Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set | Favourable | 167 Participant |
| Ceftaroline | Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set | Unfavorable | 14 Participant |
| Vancomycin/Aztreonam | Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set | Favourable | 98 Participant |
| Vancomycin/Aztreonam | Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set | Unfavorable | 14 Participant |
95% CI: [-2.11, 12.86]