Phase 4
N=12
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02504827 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Peak Plasma Concentration (Cmax) — 85.87 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ceftazidime/avibactam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration (Cmax) |
85.87 | — |
| PRIMARY Peak Sputum Concentration |
2.5 | — |
Summary
The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CF based on positive sweat chloride or know CF mutation
- Age > 17 years
- Able to spontaneously expectorate sputum
Exclusion Criteria
- Any clinically significant laboratory abnormality
- Presence of an ongoing acute pulmonary exacerbation
- Pregnancy
- Serious past allergy to a beta-lactam antibiotic
Data sourced from ClinicalTrials.gov (NCT02504827). 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.