Avibactam and Ceftazidime concentration in lung lining fluid

• Research type

  Research Study

• Full title

  A Phase I Open-Label, 2-Part, 3-Cohort, Single-Centre Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma Using at Least Two Different Dosing Regimens in Healthy Volunteers

• IRAS ID

  83438

• Contact name

  Leonard Siew

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-002556-14

• Research summary

  Ceftazidime is a licensed medication and has been used worldwide for the past 20 years to treat infections. In particular it is used to treat chest infections, skin infections, urinary tract infections, infections in the blood stream, bone and joint infections, and meningitis. Over the past 15 years there has been an increase in the number of infections that are resistant to treatment by this antibiotic.An infection that's resistant to treatment maybe due to bacteria that are resistant to the effects of Ceftazidime. These bacteria are able to break down the structure of this antibiotic making it harmless to the bacteria. Avibactam is a new compound that's being developed to prevent these bacteria from breaking down the structure of Ceftazidime and therefore overcoming the resistance of these bacteria, allowing Ceftazidime to be once again effective in treating the infection.This is not the first time that Avibactam will be administered to humans in clinical trials.This study is being carried out to see how much of this new antibiotic enters the lungs when given intravenously (through the vein) and in different doses. Up to sixty (60) male and female healthy volunteers who meet the inclusion criteria will be enrolled. Additional 3 healthy volunteers will be enrolled prior to the main study to verify that all the procedures are performed accordingly. This is known as the "Pilot? part of the study.Avibactam is being developed by AstraZeneca (the Sponsor, a pharmaceutical company) and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy??s Hospital (hereafter referred to as Quintiles).The information gained in this study will help the sponsor of this study to determine whether Avibactam is suitable for further studies in humans.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0110

• Date of REC Opinion

  21 Jul 2011

• REC opinion

  Favourable Opinion