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

Completed · Phase 1

Conditions studied: Diabetes, Wound Infection, Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02620774

Run by

Hartford Hospital

People needed

16

Starts

2016-02-19

Expected to finish

2017-04-01

Last updated by the study team

2019-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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