Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)

The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.

Time frame: Day 5 up to Day 28

Population: Participants with confirmed clinical diagnosis, adequate IV study therapy, protocol-specified visit at DCIV, and no protocol-specific exclusions. A modified last-observation-carried-forward (LOCF), where only failure was carried forward, was used to impute missing data.

Participants chose to discontinue treatment or were discontinued from the study by the investigator due to any untoward effects, or for safety reasons such as an AE. The investigator determined whether or not the AE caused the test drug to be discontinued.

Time frame: Up to day 28

Population: Participants who received at least one dose of IV study therapy

The investigator assessed participants for both a favorable clinical response (clinical improvement or cure) and a favorable microbiological response (eradication or presumptive eradication). Clinical improvement means that most pretherapy signs and symptoms of the index infection, had resolved, and no further IV antibiotic therapy is required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. Eradication means that the original pathogen was absent from the last available culture obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.

Time frame: Day 15 up to Day 38

Population: Participants with proper clinical diagnosis, adequate study therapy and clinical assessment, appropriate antimicrobial therapy, and microbiological assessment. One participant from the Ertapenem arm with indeterminate clinical response, was excluded from the analysis. A modified LOCF (failure was carried forward), was used to impute missing data.

A drug-related AE is any AE caused by the test drug as determined by an investigator who is a qualified physician. Drug-relatedness of the AE was assessed by evidence that the participant was actually exposed to the test drug, whether the AE followed a reasonable temporal sequence from administration of the test drug, and whether or not the AE was more reasonably explained by another source.

Time frame: Up to day 42

Population: Participants who received at least one dose of IV study therapy

The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.

Time frame: Day 5

Population: Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at Day 5, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.

The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.

Time frame: Day 15 up to Day 38

Population: Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at FUA, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.

The investigator assessed participants for a favorable microbiological response, defined as eradication or presumptive eradication. Eradication means that the original pathogen was absent from the last available culture of an adequate specimen obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.

Time frame: Day 15 up to Day 38

Population: Participants with proper clinical diagnosis, adequate study therapy, adequate clinical assessment, appropriate antimicrobial therapy, and proper microbiological assessment. A modified LOCF, where only failure was carried forward, was used to impute missing data.

An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the investigational product, whether or not considered related to the use of the medicinal product. This also includes any change in frequency and/or intensity of a preexisting condition which is temporally associated with the use of the medicinal product.

Time frame: Up to day 42

Population: Participants who received at least one dose of IV study therapy

A SAE is an AE occurring at any dose that resulted in any of the following: death, was life threatening, a persistent or significant disability/incapacity, prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect in an offspring, was a cancer, an overdose, or other important medical events requiring medical or surgical intervention.

Time frame: Up to day 42

Population: Participants who received at least one dose of IV study therapy