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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01280461
First received: January 19, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition
Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 142
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Groups/Cohorts
Experimental Group
Control Group

Detailed Description:

Patients fulfill inclusion/exclusion criteria will be randomly assigned (in a 1:1 ratio)to receive intravenous cefoperazone/sulbactam or intravenous cefepime for 7~21days. Vitamin K1 10mg will be administered to cefoperazone/sulbactam group every 24 hours.

The assessment of clinical sign and symptoms of pneumonia and microbiological tests will be performed at early post-therapy visit and test-of-cure visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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:

  1. Cough
  2. Fever: axillary temperature > 37.5℃ or tympanic temperature > 38.5℃
  3. Hypothermia: axillary temperature < 34℃ or tympanic temperature < 35℃
  4. Purulent sputum production or respiratory secretion
  5. 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
  6. Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
  7. 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
  • Subject has not received more than 24 hours of a parenteral antibacterial drug for the current pneumonia. If subject has received more than 24 hours of a parenteral antibacterial drug, he/she must be declared as treatment failure.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280461

Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Wen-Sen Lee Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Wen-Sen Lee, Department of Infectious Diseases, WanFang Hospital
ClinicalTrials.gov Identifier: NCT01280461     History of Changes
Other Study ID Numbers: 99067
Study First Received: January 19, 2011
Last Updated: January 19, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cefoperazone
Sulbactam
Cefepime
Sulperazone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014