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Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients

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
Pivotal Trial
No Placebo-Only Group
All Individual Drugs Already Approved
Drug Has Already Been Approved
Approved for 10 Other Conditions

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
  • CF exacerbation
  • Pseudomonas Infection
  • Cystic Fibrosis

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

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

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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
32 Previous Clinical Trials
16,182 Total Patients Enrolled
University of North CarolinaOTHER
170 Previous Clinical Trials
1,455,443 Total Patients Enrolled
5 Trials studying Cystic Fibrosis
1,096 Patients Enrolled for Cystic Fibrosis
Joseph L. Kuti, PharmDLead Sponsor
3 Previous Clinical Trials
31 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
18 Patients Enrolled for Cystic Fibrosis
Cubist Pharmaceuticals LLCIndustry Sponsor
88 Previous Clinical Trials
22,665 Total Patients Enrolled
Joseph L Kuti, PharmDPrincipal InvestigatorHartford Hospital
4 Previous Clinical Trials
43 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
30 Patients Enrolled for Cystic Fibrosis
~2 spots leftby Dec 2025
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