ertapenem sodium (mk-0826) versus piperacillin/tazobactam sodium for the treatment of diabetic foot infections in chinese adults (mk-0826-061)

Conditions: Infection; Diabetic Foot

Summary: 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.


Eligibility criteria:
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™)

Keywords: infection diabetes complications diabetes wound infection soft tissue infection osteomyelitis diabetes mellitus