Cystic Fibrosis
Conditions
Keywords
pharmacokinetics, ceftazidime/avibactam
Brief summary
The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.
Detailed description
Cystic fibrosis is a genetic disorder characterized by a chronic cycle of airway infection, obstruction, and inflammation leading to progressive loss of lung function and eventual respiratory failure. The principal pathogen is Pseudomonas aeruginosa which is present in the airways of 70% of adult patients with CF. Of particular concern is the increasing resistance observed to existing agents. While ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. Ceftazidime/avibactam offers a potential advancement in the management of infections involving P. aeruginosa in CF due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.
Interventions
Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) | 8 hours |
| Peak Sputum Concentration | 8 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Ceftazidime/Avibactam Ceftazidime/avibactam 2.5gm IV q8h for 3 doses
Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Could not produce sputum | 1 |
Baseline characteristics
| Characteristic | IV Ceftazidime/Avibactam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 33.1 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Peak Plasma Concentration (Cmax)
Time frame: 8 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Ceftazidime/Avibactam | Peak Plasma Concentration (Cmax) | 85.87 mg/L |
Primary
Peak Sputum Concentration
Time frame: 8 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Ceftazidime/Avibactam | Peak Sputum Concentration | 2.5 mg/L |