This study will compare ertapenem sodium to piperacillin/tazobactam sodium for the treatment
of moderate to severe diabetic foot infections.
Inclusion criteria:
Participant is Chinese with:
- Type I diabetes mellitus (IDDM) or Type II diabetes mellitus (NIDDM) treated with
diet and/or medication
- Clinically- or bacteriologically-documented moderate-to-severe (non life-threatening)
diabetic foot infection that requires treatment with IV antibiotics
- Wound site or lesion with purulent drainage from the primary site of infection OR at
least 3 of the following: fever, white blood count (WBC) >10,000 with >5% immature
neutrophils, local periwound erythema (redness) extending >1 cm away from the wound
edge or abscess cavity, localized periwound edema (swelling), localized tenderness or
pain, localized fluctuance, lymphangitis associated with a skin lesion, localized
warmth, and localized induration (limb brawny edema)
- Negative skin test result for allergy to penicillin
Exclusion criteria:
- Pregnant, breastfeeding, or intending to become pregnant or father a child during the
course of the study
- Presence of uncomplicated skin infection such as the following: simple abscesses,
impetigo, furunculosis, carbunculosis, or folliculitis in normal hosts; infected
burn wound; necrotizing fasciitis; suspected osteomyelitis contiguous with the skin
or skin structure infection for which removal of the infected bone is not likely to
occur within 2 days of initiation of IV study therapy; wound infection that contains
concomitant gangrene that cannot be adequately removed with debridement; infection
likely to require a below-the-knee amputation (BKA); infection involving prosthetic
material; or evidence of indwelling foreign material (such as prosthetic or surgical
hardware) near the infected site that cannot be removed by surgical debridement
- Treatment within 3 days prior to the eligibility screening with >24 hours of systemic
antibiotic therapy known to be effective against the presumed or documented etiologic
pathogen(s)
- History of serious allergy, hypersensitivity (e. g., anaphylaxis), or any serious
reaction to carbapenem antibiotics (such as ertapenem sodium, imipenem cilastatin,
meropenem, or doripenem) piperacillin/tazobactam sodium, amoxicillin/clavulanate, any
penicillins, any cephalosporins, or any other β-lactam agents
- Need for concomitant systemic antibacterial(s) in addition to those designated in the
2 study groups (with the exception of the addition of vancomycin for Enterococcus
ssp. or methicillin-resistant Staphylococcus aureus [MRSA])
- Insufficient vascular perfusion to the affected limb
- Rapidly progressive or terminal illness
- Requirement or anticipation of need for dialysis (peritoneal dialysis, hemodialysis,
or hemofiltration)
- Acute hepatitis or acute decompensation of chronic hepatitis
- Human immunodeficiency virus (HIV)-positive with a clinical diagnosis of acquired
immune deficiency syndrome (AIDS), or an absolute neutrophil count (ANC) of <1000
cells/mm^3
- Immunosuppression
- Participation in any other clinical study involving the administration of an
investigational medication within 30 days
- Participation in any other clinical study involving ertapenem sodium (INVANZ™)
