Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Diabetic Foot
Intervention: Ertapenem sodium (Drug); Piperacillin/tazobactam sodium (Drug); Piperacillin/tazobactam-matching placebo (Drug); Amoxicillin/clavulunate potassium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium in the Treatment of Diabetic Foot Infections in Chinese Adults
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV)
Secondary outcome: Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study TherapyPercentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy Percentage of Participants With One or More Adverse Events (AEs) Percentage of Participants With Drug-related AEs Percentage of Participants With Serious AEs (SAEs) Percentage of Participants Who Discontinued Treatment Due to an AE
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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™)
Locations and Contacts
Additional Information
Starting date: September 2011
Last updated: November 24, 2014
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