Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)

An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued during the study due to an AE was summarized.

Time frame: Up to 7 days after the first dose of study drug

Population: All participants who received at least 1 dose of study treatment and had follow-up data for endpoint.

An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized.

Time frame: Up to 42 days post first dose of study drug

Population: All participants who received at least 1 dose of study treatment and had follow-up data for endpoint.

The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at TOC (14 days post first dose). Microbiological outcome was classified as eradication, persistence or indeterminate. A successful microbiological response was eradication which was defined as urine culture showed all uropathogens found at baseline at ≥10\^5 colony-forming unit (CFU)/mL were reduced to \<10\^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as indeterminate were excluded.

Time frame: Day 14 (14 days post first dose of study drug)

Population: All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.

The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized.

Time frame: Day 14 (14 days post first dose of study drug)

Population: All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.

The Investigator classified clinical outcome as clinical cure, clinical failure, or indeterminate. A favorable clinical response is clinical cure defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as indeterminate were excluded. Percentage of participants with clinical response of clinical cure at EOT was summarized

Time frame: Day 7 (7 days post first dose of study drug)

Population: All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded.

The Investigator classified clinical outcome as clinical cure, clinical failure, or indeterminate. A favorable clinical response is clinical cure defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as indeterminate were excluded. Percentage of participants with clinical response of clinical cure at LFU was summarized.

Time frame: Day 42 (42 days post first dose of study drug)

Population: All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded.

The Investigator classified clinical outcome as clinical cure, clinical failure, or indeterminate. A favorable clinical response is clinical cure defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as indeterminate were excluded. Percentage of participants with clinical response of clinical cure at TOC was summarized

Time frame: Day 14 (14 days post first dose of study drug)

Population: All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded.

The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at EOT (7 days post first dose of study drug). Microbiological outcome was classified as eradication, persistence or indeterminate. A successful microbiological response was eradication which was defined as urine culture showed all uropathogens found at baseline at ≥10\^5 colony-forming unit (CFU)/mL were reduced to \<10\^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as indeterminate were excluded.

Time frame: Day 7 (7 days post first dose of study drug)

Population: All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.

The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at LFU (42 days post first dose of study drug). Microbiological outcome was classified as eradication, persistence or indeterminate. A successful microbiological response was eradication which was defined as urine culture showed all uropathogens found at baseline at ≥10\^5 colony-forming unit (CFU)/mL were reduced to \<10\^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as indeterminate were excluded.

Time frame: Day 42 (42 days post first dose of study drug)

Population: All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.

The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as Eradication, Persistence or Indeterminate. A successful microbiological response was Eradication which was defined as urine culture showed the specific pathogen found at baseline at ≥10\^5 colony-forming unit (CFU)/mL was reduced to \<10\^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as indeterminate were excluded. The percentage of participants that achieved eradication for each uropathogen at EOT (7 days post first dose of study drug) was summarized.

Time frame: Day 7 (7 days post first dose of study drug)

Population: All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.

The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as Eradication, Persistence or Indeterminate. A successful microbiological response was Eradication which was defined as urine culture showed the specific pathogen found at baseline at ≥10\^5 colony-forming unit (CFU)/mL was reduced to \<10\^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as indeterminate were excluded. The percentage of participants that achieved eradication for each uropathogen LFU (42 days post first dose of study drug) was summarized. .

Time frame: Day 42 (42 days post first dose of study drug)

Population: All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.

The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as Eradication, Persistence or Indeterminate. A successful microbiological response was Eradication which was defined as urine culture showed the specific pathogen found at baseline at ≥10\^5 colony-forming unit (CFU)/mL was reduced to \<10\^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced), the result was classified as a failure. Outcomes reported as indeterminate were excluded. The percentage of participants that achieved eradication for each uropathogen at TOC (14 days post first dose of study drug) was summarized.

Time frame: Day 14 (14 days post first dose of study drug)

Population: All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.