A PHASE III, RANDOMIZED, DOUBLE-BLIND STUDY OF CEFTOBIPROLE VERSUS LINEZOLID PLUS CEFTAZIDIME IN THE TREATMENT OF NOSOCOMIAL PNEUMONIA - CHOPIN-2
- Conditions
- osocomial Pneumonia
- Registration Number
- EUCTR2004-001730-17-HU
- Lead Sponsor
- Basilea Pharmaceutica Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
1)Written informed consent provided. Consent may be given for unconscious/ incapacitated patients by their next of kin, guardian or legal representative according to local regulatory and ethical practice using a patient information sheet and informed consent form approved by the responsible Ethics Committee.
2)Male or female patients aged = 18 years.
3)Patients who, in the opinion of the investigator, require antibiotic therapy with anti-MRSA antibiotic activity.
4)Patients suffering from NP or VAP defined as follows:
NOSOCOMIAL PNEUMONIA
a)CLINICAL DIAGNOSIS OF PNEUMONIA AFTER
? A MINIMUM OF 72 HOURS OF HOSPITALISATION OR IN A CHRONIC CARE FACILITY
? = 48 TO < 72 HOURS OF HOSPITALISATION OR INA CHRONIC CARE FACILITY IF AT ADMISSION NO ACUTE INFLAMMATORY
PULMONARY INFILTRATE WAS PRESENT, WBC AND DIFFERENTIAL BLOOD COUNT WAS NORMAL AND THE REASON FOR ADMISSION
WAS NOT AN INFECTION.
? DISCHARGE FROM HOSPITAL R CHRONIC CARE FACILITY = 48 HOURS AFTER A STAY OF = 72 HOURS
WITH AT LEAST TWO (2) OF THE FOLLOWING CRITERIA:
•NEW ONSET OF PURULENT SPUTUM PRODUCTION OR RESPIRATORY SECRETIONS OR A WORSENING IN CHARACTER OF SPUTUM.
•TACHYPNEA (RESPIRATORY RATE ? 20/MINUTE), PARTICULARLY IF ANY OR ALL OF THESE ARE PROGRESSIVE IN NATURE.
•HYPOXEMIA WITH A P02 < 60 MMHG WHILE PATIENT IS BREATHING ON ROOM AIR, AS DETERMINED BY PULSE OXIMETRY OR ARTERIAL BLOOD GAS, OR ALVEOLOAR ARTERIAL O2 GRADIENT, OR RESPIRATORY FAILURE REQUIRING MECHANICAL VENTILATION.
b)NEW OR PERSISTENT RADIOGRAPHIC INFILTRATES (NOT RELATED TO ANOTHER DISEASE PROCESS) IN CONJUNCTION WITH AT LEAST ONE OF THE FOLLOWING:
? FEVER (IN THE ABSENCE OF ANTI-PYRETICS), INCREASE IN CORE TEMPERATURE OF > 1ºC OR AN ORAL TEMPERATURE >?38?C, A TYMPANIC TEMPERATURE >?38.5?C, A RECTAL/CORE TEMPERATURE >?39?C, OR HYPOTHERMIA, DEFINED AS A RECTAL/CORE BODY TEMPERATURE OF 35?C.<br? LEUKOCYTOSIS (25% INCREASE IN CIRCULATING LEUKOCYTES FROM BASELINE AND A TOTAL WBC COUNT =10 X 109/L OR =?15% IMMATURE NEUTROPHILS (BANDS), REGARDLESS OF TOTAL PERIPHERAL WHITE COUNT; OR LEUCOPENIA WITH TOTAL WBC< 4.5?X 109/L.
2,Persistence is defined as the infiltrate being radiographically visible for at leaset 72 hours
Ventilator- Associated Pneumonia
PATIENTS WHO DEVELOP NOSOCOMIAL PNEUMONIA (AS DEFINED ABOVE) MORE THAN 48 HOURS AFTER ONSET OF MECHANICAL VENTILATON
5)Microbiological samples(RESPIRATORY SECRETION) suitable for culture.
6)APACHE II score = 8 and = 25.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
General
1)Female PATIENTS who are pregnant or lactating.
2)Women of childbearing potential unable or unwilling to USE AN EFFECTIVE METHOD OF BIRTH CONTROL
3)KNOW OR SUSPECTED Hypersensitivity to any study medication (including ? lactam antibiotics such as penicillins, cephalosporins, oxazolidinone, or monobactams)
4)Any KNOW OR SUSPECTED condition or concurrent treatment contraindicated by the prescribing information for linezolid or ceftazidime.
5)KNOW OR SUSPECTED severe renal impairment, (calculated creatinine clearance [CrCl] < 30 mL/minute, or oliguria < 20 mL/h unresponsive to fluid challenge) or any form of dialysis.
6)KNOW OR SUSPECTED Hepatic dysfunction (total bilirubin, or alanine aminotransferase [ALT], or aspartate aminotransferase [AST] ? 3 x upper limit of the normal range [ULN]).
7)Previous enrollment in this study.
8)Treatment with any investigational drug within 30 days before enrollment.
9)Any otherKNOW OR SUSPECTED condition of the patient that may jeopardize adherence to protocol requirements.
Clinical conditions that may interfere with assessments of efficacy
10)Sustained shock (e.g. systolic blood pressure [BP] 90 mmHg for ?2 hours despite FLUID RESUSCITATION WITH EVIDENCE OF HYPOPERFUSION OR NEED FOR SYMPATHOMIMETIC AGENTS.
11)Patients with either
- known bronchial obstruction or a history of post-obstructive pneumonia (chronic obstructive pulmonary disease [COPD] patients are allowed) including
primary lung cancer or another malignancy metastatic to the lungs,
- cystic fibrosis,
- lung abscess,
- infected pleural effusion
- active tuberculosis, or
- patients requiring antibiotic cover for aspiration pneumonia, atypical pneumonia or Pneumocystis jiroveci (carinii) pneumonia.
12)KNOWN OR SUSPECTED Neutropenic subjects (absolute neutrophil count [ANC] ? 0.5?x?109/L),
13)KNOWN OR SUSPECTED patients with CD4 counts ??0.2?x?109/L.
Microbiological conditions that may interfere with assessment of efficacy:
13)Systemic antimicrobial therapy for more than 24 hours in the 7 days prior to enrollment
Systemic antimicrobial therapy for > 24 hours is permitted in case:
a) the infection is caused by microbiologically-confirmed pathogens that are resistant to the previous antimicrobial agents.
b) the patient is clinically deteriorating despite at least 72 hours of treatment.
14)Evidence from available surveillance cultures of (co-)infection with pathogen(s) such as:
- ESBL producers,
- Proteus vulgaris and
- Ceftazidime- or ceftobiprole-resistant non-fermenters
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method