An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia

NCT01280461 | Unknown DMC

• 1 other identifier: 99067
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase III, multi-center, open-label, comparative and randomized study in evaluating the efficacy and safety of cefoperazone/sulbactam versus cefepime for the treatment of hospital-acquired pneumonia and healthcare-associated pneumonia. The investigator will determine the total duration of study therapy, as clinically indicated. The minimum duration of study therapy will be 7 days and the maximum allowable duration of study therapy will be 21 days.

Conditions

Pneumonia

Keywords

Pneumonia

Study Arms (2)

Experimental Group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with nosocomial bacterial pneumonia or healthcare-associated pneumonia(HCAP)

You may qualify if:

• Male or female patients aged ≧18 years old
• Patients with nosocomial bacterial pneumonia at least 48 hours after hospitalization or patients with healthcare-associated pneumonia(HCAP\*).
• Clinical findings
• At least two of the following signs:
• Cough
• Fever: axillary temperature \> 37.5℃ or tympanic temperature \> 38.5℃
• Hypothermia: axillary temperature \< 34℃ or tympanic temperature \< 35℃
• Purulent sputum production or respiratory secretion
• Total peripheral white blood cell (WBC) count \> 10,000/mm3; or \> 15% band forms, regardless of total peripheral white count; or leucopenia with total WBC \< 4500/mm3
• Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
• Hypoxemia (defined as a partial O2 pressure \<60 mmHg while the patient was breathing normal air or a decrease in the partial O2 pressure of ≧25% from an initial value)
• Radiographic findings The chest radiograph should show the presence of a new or progressive infiltration on the chest X-ray film
• Microbiologic criteria If sputum specimen is available and collected, both tests are mandatory with at least one of the following results is positive:
• (1) Within 24 hours prior to, or at the time of enrollment, all patients should have had a culture and susceptibility testing of respiratory secretions or sputum to study drugs (2)Gram stain of respiratory secretions or sputum
• Patient must be able to sign a written informed consent form prior to the start of the study procedures. If any patient is unable to give consent, it must be obtained from the patient's legal representative

You may not qualify if:

• Woman who are pregnant (determined by urine test) or lactating state
• Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not exclude patients who have chronic obstructive pulmonary disease)
• A neutrophil count \<1000/mm3
• Patients with pneumonia due to viral, fungal, or mycobacterial infection.
• Patients who were known to have been infected with human immunodeficiency virus
• Documented Legionella pneumonia
• Patients were infected with gram negative (G-) microorganism known to be resistant to one of the study antibiotics during trial
• Subjects with sputum gram stain of PMN\>25, epithelial cell \<10, and gram positive (G+) cocci in cluster predominant and phagocytosis
• Patients who have received any other investigational drug within 30 days prior to enrollment
• Patients who have received medications like cefoperazone, cefoperazone/sulbactam and cefepime within 30 days prior to enrollment
• Patients with abnormal pre-therapy laboratory data: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≧ 3X ULN (upper limit of normal); or serum creatinine, urea nitrogen \> 3X ULN
• A history of hypersensitivity to penicillins, cephalosporins, carbapenems or J-lactam/J-lactamase inhibitors
• Severe disease (eg. septic shock, acute respiratory distress syndrome, and multiple organ failure) which may limit survival during therapy and follow-up period, or confound the results of the study as judged by the investigator

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wen-Sen Lee

  Taipei Medical University WanFang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 20, 2011
• Study Start: July 1, 2010
• Study Completion: December 1, 2011
• Last Updated: January 20, 2011

Record last verified: 2011-01

Locations

TW (1)