Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)

NCT ID: NCT01370616

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 565 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-02
• Study Completion Date: 2013-12-18

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.

Conditions

Infection; Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ertapenem sodium

Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

Group Type: EXPERIMENTAL

Ertapenem sodium

Intervention Type: DRUG

Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days

Piperacillin/tazobactam-matching placebo

Intervention Type: DRUG

Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days

Amoxicillin/clavulunate potassium

Intervention Type: DRUG

If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

Piperacillin/tazobactam sodium

Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

Group Type: ACTIVE_COMPARATOR

Piperacillin/tazobactam sodium

Intervention Type: DRUG

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

Amoxicillin/clavulunate potassium

Intervention Type: DRUG

If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

Interventions

Ertapenem sodium

Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days

Intervention Type: DRUG

Piperacillin/tazobactam sodium

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

Intervention Type: DRUG

Piperacillin/tazobactam-matching placebo

Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days

Intervention Type: DRUG

Amoxicillin/clavulunate potassium

If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28

Intervention Type: DRUG

Other Intervention Names

MK-0826, INVANZ™; Tazocin™

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™)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 26888908 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0826-061

Identifier Type: -

Identifier Source: org_study_id