Trial Outcomes & Findings for Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin (NCT NCT01561469)

NCT ID: NCT01561469

Last Updated: 2014-07-10

Results Overview

Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.

Recruitment status

COMPLETED

Target enrollment

188 participants

Primary outcome timeframe

14 days after diagnosis with VAP or hospital discharge, whichever occurred first

Results posted on

2014-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Linezolid Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Vancomycin Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Overall Study STARTED	101	87
Overall Study COMPLETED	101	87
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Linezolid n=101 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Vancomycin n=87 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Total n=188 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	56 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	49 Participants n=7 Participants	112 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days after diagnosis with VAP or hospital discharge, whichever occurred first

Population: Analysis population included all participants who met the eligibility criteria for this study.

Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.

Outcome measures

Outcome measures
Measure	Linezolid n=101 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Vancomycin n=87 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Percentage of Participants With Clinical Success	85 percentage of participants	69 percentage of participants

SECONDARY outcome

Timeframe: 28 days after diagnosis of VAP

Population: Analysis population included all participants who met the eligibility criteria for this study.

Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).

Outcome measures

Outcome measures
Measure	Linezolid n=101 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Vancomycin n=87 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Number of Participants With Microbiological Outcome Superinfections	42 participants	37 participants
Number of Participants With Microbiological Outcome Colonization	34 participants	32 participants

SECONDARY outcome

Timeframe: Up to 28 days after diagnosis of VAP

Population: Analysis population included all participants who met the eligibility criteria for this study.

Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.

Outcome measures

Outcome measures
Measure	Linezolid n=101 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Vancomycin n=87 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Duration of Hospital Stay	18 days Interval 10.0 to 28.0	16 days Interval 11.0 to 25.5

SECONDARY outcome

Timeframe: Up to 28 days after diagnosis of VAP

Population: Analysis population included all participants who met the eligibility criteria for this study.

Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.

Outcome measures

Outcome measures
Measure	Linezolid n=101 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Vancomycin n=87 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Duration of Intensive Care Unit (ICU) Stay	11 days Interval 8.0 to 22.0	13 days Interval 8.0 to 19.5

SECONDARY outcome

Timeframe: Up to 28 days after diagnosis of VAP

Population: Analysis population included all participants who met the eligibility criteria for this study.

Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.

Outcome measures

Outcome measures
Measure	Linezolid n=101 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Vancomycin n=87 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Duration of Mechanical Ventilation	11 days Interval 11.0 to 24.0	13 days Interval 9.5 to 24.0

SECONDARY outcome

Timeframe: Up to 28 days after diagnosis of VAP

Population: Analysis population included all participants who met the eligibility criteria for this study.

Outcome measures

Outcome measures
Measure	Linezolid n=101 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.	Vancomycin n=87 Participants Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
Duration of Antimicrobial Treatment	11 days Standard Deviation 4	11 days Standard Deviation 5

SECONDARY outcome

Timeframe: Up to 28 days after diagnosis of VAP

Population: Data was not analyzed for this outcome because other reported measures (that is, duration of antimicrobial treatment, duration of mechanical ventilation, duration of ICU stay, duration of hospital stay) were considered to represent a more strict and useful reflection of resource utilization.

Outcome measures

Outcome data not reported

Adverse Events

Linezolid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vancomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER