Phase 1
N=16
Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections
Diabetes · Wound Infection · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02620774 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Ceftolozane Tissue Penetration — 0.75; 0.87 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ceftolozane/tazobactam (Drug); Microdialysis Catheter Insertion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hartford Hospital
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ceftolozane Tissue Penetration |
0.75; 0.87 | — |
| PRIMARY Tazobactam Tissue Penetration |
1.18; 0.85 | — |
| SECONDARY Ceftolozane Area Under the Curve (AUC) in Tissue |
121.5; 130.6 | — |
| SECONDARY Tazobactam AUC in Tissue |
15.8; 13.8 | — |
| SECONDARY Ceftolozane Total Drug AUC in Plasma |
191.6; 191.3 | — |
| SECONDARY Tazobactam Total Drug AUC in Plasma |
27.1; 22.2 | — |
| SECONDARY Number of Participants With Adverse Events |
1; 0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02620774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.