A study comparing Ceftazidime-Avibactam versus Meropenem in hospitalized adults with nosocomial pneumonia

Phase 1

Conditions: nosocomial pneumonia (NP), ventilator-associated pneumonia (VAP)
MedDRA version: 18.0Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaSystem Organ Class: 100000004862
MedDRA version: 18.0Level: LLTClassification code 10052596Term: Nosocomial pneumoniaSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2012-004006-96-GR

Lead Sponsor: Astrazeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1494

Inclusion Criteria

18 to 90 years of age inclusive
Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after
Onset of symptoms =48 hours after admission or <7 days after discharge from an inpatient acute or chronic care facility
New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization
At least 1 of the following systemic signs:
- Fever (temperature >38°C) or hypothermia (rectal/core temperature <35°C)
- White blood cell count >10,000 cells/mm3, or White blood cell count <4500 cells/mm3, or >15% band forms
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 961
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 553

Exclusion Criteria

Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
Patients with lung abscess, pleural empyema or post obstructive pneumonia.
Patients with an estimated creatinine clearance =50 ml/min by Cockcroft Gault
formula (See Appendix E) or patients expected to require haemodialysis or other renal support
while on study therapy. (For patients enrolled into the study whose creatinine clearance drops
to =50 ml/min while on IV study therapy, the study drug dosing instructions are provided in
sections 5.5.1.2 and 5.5.1.3 and should be closely followed).
Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
Patients receiving hemodialysis or peritoneal dialysis.