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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Complicated Urinary Tract Infection; Complicated Intra-abdominal Infection

Treatments: Drug: Best Available Therapy; Drug: Metronidazole; Drug: Ceftazidime - Avibactam ( CAZ-AVI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01644643

2012-000726-21

D4280C00006

Details and patient eligibility

About

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

Full description

An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

Enrollment: 345 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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345 participants in 2 patient groups

Ceftazidime - Avibactam ( CAZ-AVI)

Experimental group

Description:

IV treatment

Treatment:

Drug: Metronidazole

Drug: Ceftazidime - Avibactam ( CAZ-AVI)

Best Available Therapy

Active Comparator group

Description:

IV treatment

Treatment:

Drug: Best Available Therapy