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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01370616
First received: June 8, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

This study will compare ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections.


Condition Intervention Phase
Infection; Diabetic Foot
Drug: Ertapenem sodium
Drug: Piperacillin/tazobactam sodium
Drug: Piperacillin/tazobactam-matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants with clinical improvement or cure [ Time Frame: Day 5 (or up to Day 28) at the discontinuation of intravenous therapy visit (DCIV) ] [ Designated as safety issue: No ]

Enrollment: 565
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ertapenem sodium
Participants on this arm will receive intravenous (IV) ertapenem sodium and piperacillin/tazobactam-matching placebo for 5 to 28 days. Participants may be switched to oral antibiotics beginning on Day 6 if clinically indicated.
Drug: Ertapenem sodium
Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days
Other Name: MK-0826, INVANZ™
Drug: Piperacillin/tazobactam-matching placebo
Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days
Active Comparator: Piperacillin/tazobactam sodium
Participants on this arm will receive IV piperacillin/tazobactam for 5 to 28 days. Participants may be switched to oral antibiotics beginning on Day 6 if clinically indicated.
Drug: Piperacillin/tazobactam sodium
Piperacillin/tazobactam sodium, 4.5 g, IV every 6 hours, given over 30 minutes at Hours 0, 8, and 16 for 5 to 28 days
Other Name: Tazocin™

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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™)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01370616     History of Changes
Other Study ID Numbers: 0826-061
Study First Received: June 8, 2011
Last Updated: January 16, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Infection
Diabetes complications
Diabetes wound infection
Soft tissue infection
Osteomyelitis
Diabetes mellitus

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Piperacillin
Penicillanic Acid
Piperacillin-tazobactam combination product
Ertapenem
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014