Clinical trial NCT01370616: Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection; Diabetic Foot
Keywords: Infection
Diabetes complications
Diabetes wound infection
Soft tissue infection
Osteomyelitis
Diabetes mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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™)

Primary outcomes:
measure: Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV)
timeFrame: Day 5 up to Day 28
Secondary outcomes:
measure: Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy
timeFrame: Day 5
measure: Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy
timeFrame: Day 15 up to Day 38
measure: Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy
timeFrame: Day 15 up to Day 38
measure: Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy
timeFrame: Day 15 up to Day 38
measure: Percentage of Participants With One or More Adverse Events (AEs)
timeFrame: Up to day 42
measure: Percentage of Participants With Drug-related AEs
timeFrame: Up to day 42
measure: Percentage of Participants With Serious AEs (SAEs)
timeFrame: Up to day 42
measure: Percentage of Participants Who Discontinued Treatment Due to an AE
timeFrame: Up to day 28
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Xu ZR, Ran XW, Xian Y, Yan XD, Yuan GY, Mu SM, Shen JF, Zhang BS, Gan WJ, Wang J. Ertapenem versus piperacillin/tazobactam for diabetic foot infections in China: a Phase 3, multicentre, randomized, double-blind, active-controlled, non-inferiority trial. J Antimicrob Chemother. 2016 Jun;71(6):1688-96. doi: 10.1093/jac/dkw004. Epub 2016 Feb 16.