Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck & Co.), a novel β-lactam/β-lactamase combination antibiotic, into the extracellular, interstitial fluid of soft tissue in diabetic patients with lower limb wound infections. Penetration will be compared with a group of healthy volunteer control participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hartford Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Ceftolozane; Ceftolozane, tazobactam drug combination; Cephalosporins; Penicillanic Acid; Tazobactam

Criteria

Inclusion Criteria:

• Experimental: Type 1 or Type 2 diabetes and a mild to moderate (Grade 2 or 3) wound infection of the lower limb

• Active Comparator: Healthy Adult Volunteer

Exclusion Criteria:

All Participants:

• Less than 18 years of age

• History of hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, or any β-lactam antibiotic

• History of hypersensitivity to lidocaine or lidocaine derivatives

• Females who are pregnant or breastfeeding

• Concomitant receipt of any β-lactams antibiotic

• Concomitant receipt of probenecid

• Reduced kidney function defined as creatinine clearance of ≤ 50 mL/min

• Any other reason felt by the investigator to potentially affect the outcomes of the study

Experimental Group Only:

• No palpable pedal pulses present

• Participants likely to require multiple surgical interventions during the study period, which therefore could affect placement of the microdialysis catheter

Active Comparator Group Only:

• Positive urine drug screen (cocaine, tetrahydrocannabinol, opiates, benzodiazepines, and amphetamines)

• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.

• Use of tobacco- or nicotine-containing products in excess of the equivalence of 5 cigarettes per day.

• Use of prescription or nonprescription drugs, vitamins, or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, with the exception of acetaminophen at doses of ≤ 1 g/day. Herbal supplements, hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing intrauterine devices (IUDs), postcoital contraceptive methods), and hormone replacement therapy must be discontinued at least 14 days prior to the first dose of study medication. Depo-Provera® must be discontinued at least 6 months prior to the first dose of study medication.