Phase 4
Completed N=12
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
Source: ClinicalTrials.gov NCT02504827 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Peak Plasma Concentration (Cmax) — 85.87 mg/L
◆ Published Evidence
Established
48citations · ~5 / year
Pharmacokinetic-Pharmacodynamic Target Attainment Analyses To Determine Optimal Dosing of Ceftazidime-Avibactam for the Treatment of Acute Pulmonary Exacerbations in Patients with Cystic Fibrosis.
Summary
The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.
Linked Publications
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Pharmacokinetic-Pharmacodynamic Target Attainment Analyses To Determine Optimal Dosing of Ceftazidime-Avibactam for the Treatment of Acute Pulmonary Exacerbations in Patients with Cystic Fibrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration (Cmax) |
85.87 | — |
| PRIMARY Peak Sputum Concentration |
2.5 | — |
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) and the linked publication. 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. Informational only — not medical advice.