Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis

University of Southern California

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis

Treatments: Drug: Ceftazidime/avibactam

Study type: Interventional

Funder types: Other

Identifiers

NCT02504827

APP-15-01273

Details and patient eligibility

About

The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

IV Ceftazidime/Avibactam

Experimental group

Description:

Ceftazidime/avibactam 2.5gm IV q8h for 3 doses

Treatment:

Drug: Ceftazidime/avibactam