Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as success (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); failure: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; unknown: extenuating circumstances precluding classification to 1 of above. Unknown was excluded from present analysis.

Time frame: EOS (6 to 28 days after the last dose of study drug)

Population: PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure.

CR evaluated at EOT visit as success (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); failure: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; unknown: extenuating circumstances precluding classification to 1 of above. Unknown: excluded from present analysis.

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

Population: PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure.

CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as success (cure: resolution of clinical signs/symptoms of infection when compared to baseline); failure: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; unknown: extenuating circumstances precluding classification to 1 of above. Unknown was excluded from present analysis.

Time frame: EOS (6 to 28 days after the last dose of study drug)

Population: mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure.

CR evaluated at EOT visit as success (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); failure: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; unknown: extenuating circumstances precluding classification to 1 of above. Unknown: excluded from present analysis.

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

Population: mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure.

Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.

Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)

Population: mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.

Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.

Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)

Population: PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.

Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.

Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)

Population: mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. N(number of participants analyzed)=participants evaluable for the measure.

Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.

Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)

Population: PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.N(number of participants analyzed) = participants evaluable for the measure.

Microbiological outcome dichotomized to success (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and failure (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).

Time frame: EOS (6 to 28 days after the last dose of study drug)

Population: mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure.

Microbiological outcome dichotomized to success (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and failure (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).

Time frame: EOS (6 to 28 days after the last dose of study drug)

Population: PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure.

Microbiological outcome dichotomized to success (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and failure (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).

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

Population: mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure.

Microbiological outcome dichotomized to success (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and failure (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).

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

Population: PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure.

Medical resources utilization included a daily log of the participants' location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.

Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)

Population: Data was not analyzed for the primary reporting.

Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; 0= none, 1= mild, 2= moderate and 3= severe.

Time frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)

Population: mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. Here, 'n' signified participants who were evaluable and analyzed for specific clinical signs and symptoms.

Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; 0= none, 1= mild, 2= moderate and 3= severe.

Time frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)

Population: PP set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen, satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days),observed outcome at EOS visit unless declared failure prior to the visit.Here,'n'=participants evaluable for specific clinical signs and symptoms.