Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013)

The percentage of participants withdrawing from study therapy due to an AE was determined.

Time frame: Up to Day 14

Population: All participants who received ≥1 dose of study therapy are included.

The percentage of participants with ≥1 AEs was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to Day 42 (up to 28 days after completing study therapy)

Population: All participants who received ≥1 dose of study therapy are included.

The percentage of participants with clinical responses (cure, failure, or indeterminate) at TOC was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure.

Time frame: Day 28 (28 days after initiating study therapy)

Population: Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at the TOC visit within the specified visit window are included.

The percentage of participants with clinical responses (cure, failure, or indeterminate) at EOT was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure.

Time frame: Up to Day 14

Population: Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at EOT visit within the specified visit window are included.

The percentage of participants with clinical responses (cure, failure, or indeterminate) at LFU was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure.

Time frame: Up to Day 42 (28 days after completing study therapy)

Population: Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at LFU visit within the specified visit window are included.

The percentage of participants with microbiological responses (eradication, persistence, or indeterminate) at EOT was determined. Eradication was defined as absence of the baseline pathogen in a specimen. Persistence was defined as presence of the baseline pathogen in a specimen. Indeterminate was defined as Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response.

Time frame: Up to Day 14

Population: Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the EOT visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.

The percentage of participants with microbiological response (eradication, persistence, or indeterminate) at TOC was determined. Eradication was defined as absence of the baseline pathogen in a specimen. Persistence was defined as presence of the baseline pathogen in a specimen. Indeterminate was defined as Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response.

Time frame: Day 28 (28 days after initiating study therapy)

Population: Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the TOC visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.

The percentage of participants with per-pathogen microbiological responses at EOT was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown.

Time frame: Up to Day 14

Population: Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the EOT visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.

The percentage of participants with per-pathogen microbiological responses at TOC was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown.

Time frame: Day 28 (28 days after initiating study therapy)

Population: Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the TOC visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.