Expired Study
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Los Angeles, California 90089


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

APP-15-01273


NCT ID:

NCT02504827


Secondary ID:


Study Acronym:


Brief Title:

Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis


Official Title:

Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Southern California


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:Paul Beringer, PharmD
Principal Investigator
University of Southern California

Study Dates

Start Date:September 2015
Completion Date:October 2016
Completion Type:Actual
Primary Completion Date:October 2016
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 29, 2018
First Received Date:July 20, 2015
First Results Date:September 4, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Peak Sputum Concentration
Time Frame:8 hours
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Peak Plasma Concentration (Cmax)
Time Frame:8 hours
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ceftazidime/avibactam
Description:Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
Arm Name:IV Ceftazidime/Avibactam
Other Name:Avycaz

Study Arms

Study Arm Type:Experimental
Arm Name:IV Ceftazidime/Avibactam
Description:Ceftazidime/avibactam 2.5gm IV q8h for 3 doses

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Southern California

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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