Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
Condition: Infection; Diabetic Foot
MeSH terms: Infections; Communicable Diseases; Diabetic Foot
Intervention: Ertapenem sodium; Piperacillin/tazobactam sodium; Piperacillin/tazobactam-matching placebo; Amoxicillin/clavulunate potassium
Intervention description: 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; If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
Intervention MeSH terms: Amoxicillin; Tazobactam; Piperacillin; Ertapenem; Piperacillin, Tazobactam Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 565.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Infection; Diabetes complications; Diabetes wound infection; Soft tissue infection; Osteomyelitis; Diabetes mellitus

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™)