DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Therapy

Percentage 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017