This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections. The primary hypothesis was that treatment with ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in achieving clinical improvement or cure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
565
Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days
Piperacillin/tazobactam sodium, 4.5 g, IV every 8 hours, given over 30 minutes at Hours 0, 8, and 16 for 5 to 28 days
Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days
Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV)
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
Percentage of Participants With Favorable Clinical Response Assessments at Day 5 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
Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic 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 15 up to Day 38
Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy
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If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
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
Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic 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
Percentage of Participants With One or More Adverse Events (AEs)
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
Percentage of Participants With Drug-related AEs
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
Percentage of Participants With Serious AEs (SAEs)
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
Percentage of Participants Who Discontinued Treatment Due to an AE
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