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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014