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Ceftolozane/Tazobactam for Cystic Fibrosis

Phase 4
Waitlist Available
Led By Joseph L Kuti, PharmD
Research Sponsored by Joseph L. Kuti, PharmD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose
Awards & highlights

Study Summary

There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Ceftolozane/Tazobactam is a newly approved broad spectrum intravenous antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, the most common pathogen implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of ceftolozane/tazobactam in 20 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of ceftolozane/tazobactam 3 grams every 8 hours. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of ceftolozane and tazobactam. Safety and tolerability will be assessed throughout the 3 day study.

Eligible Conditions
  • Cystic Fibrosis
  • Pseudomonas Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ceftolozane Clearance
Ceftolozane Volume of Distribution (Central Compartment)
Tazobactam Clearance
+1 more
Secondary outcome measures
Ceftolozane Probability of Target Attainment at 8 mcg/ml

Side effects data

From 2016 Phase 4 trial • 21 Patients • NCT02421120
10%
Hypokalemia
5%
Vaginal Itching
5%
Liver Function Test Elevation
5%
Type I Hypersensitivity Reaction
5%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ceftolozane/Tazobactam

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ceftolozane/TazobactamExperimental Treatment1 Intervention
Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftolozane
FDA approved

Find a Location

Who is running the clinical trial?

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry Sponsor
88 Previous Clinical Trials
22,665 Total Patients Enrolled
St. Christopher's Hospital for ChildrenOTHER
9 Previous Clinical Trials
3,280 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
16 Patients Enrolled for Cystic Fibrosis
Indiana University HealthOTHER
30 Previous Clinical Trials
15,767 Total Patients Enrolled

Frequently Asked Questions

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~2 spots leftby May 2025