Interaction study of Avibactam and Ceftazidime

• Research type

  Research Study

• Full title

  A Phase I, 2-Part, Open-Label, Pharmacokinetic and Drug-Drug Interaction Study of CAZ104 (Avibactam and Ceftazidime in Healthy Subjects)

• IRAS ID

  85875

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-003289-34

• 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 is resistant to treatment maybe due to bacteria that are resistant to the effects of Ceftazidime. These bacteria are able to breakdown the structure of this antibiotic making it harmless to the bacteria. Avibactam is a new compound that is 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.In this study we will be investigating how much of Avibactam and Ceftazidime enters the blood when Avibactam and Ceftazidine are given separately or together intravenously (through the vein). We are also investigating the effect of prolonged dosing (ten days) with Avibactam and Ceftazidime when given together and how this will effect how much of Avibactam and Ceftazidime enters the blood. Approximately 43 male and female healthy volunteers who meet the inclusion criteria will be enrolled. 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 gathered from this study would help the sponsor develop this new antibiotic in particular its usefulness in treating patients with chest infections.

• REC name

  Scotland A REC

• REC reference

  11/IE/0123

• Date of REC Opinion

  29 Sep 2011

• REC opinion

  Further Information Favourable Opinion