Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

Completed · Phase 3

Conditions studied: Complicated Urinary Tract Infection, Complicated Intra-abdominal Infection

In brief

To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

Key facts

Study ID

NCT01644643

Run by

Pfizer

People needed

345

Starts

2013-01-01

Expected to finish

2014-09-01

Last updated by the study team

2017-09-29

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be ≥18 and ≤90 years of age
• Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
• Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection

You may not qualify if…

• Patient has an APACHE II score >30 (cIAI patients only)
• Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
• Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
• Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.

Where it is running

• Research Site — Shreveport, Louisiana, United States
• Research Site — Lima, Ohio, United States
• Research Site — El Talar, Argentina
• Research Site — La Plata, Argentina
• Research Site — Pazardzhik, Bulgaria
• Research Site — Pleven, Bulgaria
• Research Site — Rousse, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Varna, Bulgaria
• Research Site — Veliko Tarnovo, Bulgaria
• Research Site — Slavonski Brod, Croatia
• Research Site — Zagreb, Croatia
• Research Site — Prague, Czechia
• Research Site — Tours, France
• Research Site — Nazareth, Israel
• Research Site — Petah Tikva, Israel
• Research Site — Ramat Gan, Israel
• Research Site — Tel Aviv, Israel
• Research Site — Guadalajara, Mexico
• Research Site — Mexico City, Mexico
• Research Site — Cusco, Peru
• Research Site — Surco, Peru
• Research Site — Manila, Philippines
• Research Site — Szczecin, Poland
• Research Site — Bucharest, Romania

Full record on ClinicalTrials.gov

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