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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014