Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.

Time frame: EOS (7-30 days after last dose)

Population: PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit.

Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.

Time frame: EOT (within 72 hours of last dose)

Population: PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.

Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.

Time frame: EOS (7-30 days after last dose)

Population: mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.

Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.

Time frame: EOT (within 72 hours of last dose)

Population: mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.

Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.

Time frame: EOS (7-30 days after last dose)

Population: mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.

Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.

Time frame: EOS (7-30 days after last dose)

Population: PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.

Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.

Time frame: EOT (within 72 hours of last dose)

Population: mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.

Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.

Time frame: EOT (within 72 hours of last dose)

Population: PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.

Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 \<60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.

Time frame: EOS (7-30 days after last dose)

Population: mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.

Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 \<60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.

Time frame: EOS (7-30 days after last dose)

Population: PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.

Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 \<60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.

Time frame: EOT (within 72 hours of last dose)

Population: mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.

Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 \<60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.

Time frame: EOT (within 72 hours of last dose)

Population: PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.

For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.

Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

Population: ITT population included all participants who received at least one dose of study medication.

For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.

Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

Population: mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA.

For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.

Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.

Population: PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.