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A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia

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ClinicalTrials.gov Identifier: NCT01561794
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

March 21, 2012
March 23, 2012
April 27, 2015
May 2012
March 2015   (Final data collection date for primary outcome measure)
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: Up to 30 (±5) days after the end of treatment ]
  • AUC (Area under the blood concentration/time curve) [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ]
  • Cmax (Maximum observed concentration) [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ]
  • AUC/MIC (Minimum inhibitory concentration) [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ]
  • Cmax/MIC [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ]
  • AUC/MPC (Mutant prevention concentration) [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ]
  • Cmax/MPC [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ]
Same as current
Complete list of historical versions of study NCT01561794 on ClinicalTrials.gov Archive Site
  • Clinical response rate based on resolution of signs and symptoms [ Time Frame: Up to 13 days after the first study drug administration ]
  • Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients [ Time Frame: Up to 23 days after the first study drug administration ]
  • Test of cure rate based on resolution of signs, symptoms, and the clinical response [ Time Frame: Up to 23 days after the first study drug administration ]
Same as current
Not Provided
Not Provided
 
A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
A Prospective, Non-randomized, Open-label, Non-controlled, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics/ Pharmacodynamics of BAYQ3939 (400 mg BID and TID) in Hospitalized Patients With Bacterial Pneumonia or Secondary Infection of Chronic Respiratory Disease With Severe Disease or a Poor Response to Other Antimicrobials
The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pneumonia
Drug: Ciprofloxacin (Cipro, BAYQ3939)

(1) Community-acquired pneumonia (CAP): 400 mg BID, i.e. every 12 ± 1 hours (For those with Ccr > 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days.

2) Hospital-acquired pneumonia (HAP): For the patient with Ccr > 60 mL/min, 400 mg TID, i.e. every 8 ± 1hours for 7 to 14 days For the patient with 30 ≤Ccr ≤60 mL/min, 400 mg BID, i.e. every 12 ± 1hours for 7 to 14 days 3) Secondary infection of chronic respiratory disease 400 mg BID, i.e. every 12 ± 1 hours (For those with of Ccr > 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days.

Experimental: Ciprofloxacin
Intervention: Drug: Ciprofloxacin (Cipro, BAYQ3939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
30
March 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older.
  • Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage [BAL], protected brushing specimen [PBS]), or should have appropriate specimens highly likely to identify the pathogens sampled. (However, the patients with Legionellosis is enrolled when the test of Legionella antigen is positive.)
  • The following severe bacterial pneumonia meeting the diagnostic criteria of pneumonia or secondary infection of chronic respiratory disease

    • Severe pneumonia

      • Community-acquired pneumonia: PORT score III, IV or V
      • Hospital-acquired pneumonia [HAP]-Group B and with a low risk for multidrug-resistant pathogens
      • Patients with [HAP]-Group A whose pathogen is suspected to be Pseudomonas aeruginosa
      • Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with-Group A or B who don't respond to or have a poor response to other antimicrobials over 3day's treatment.2
    • Secondary infection of chronic respiratory disease

      • Patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease
      • Hospitalized patients with secondary infection of chronic respiratory disease with a poor response to other antimicrobials Note: The patients should be limited to secondary infection of chronic respiratory disease patients who don't respond to or have a poor response to other antimicrobials over 3day's treatment.

Exclusion Criteria:

  • Creatinine clearance (Ccr) ≤ 30 mL/min or nephrotic syndrome
  • Patient with chronic treatment of immunosuppressive drug
  • Decompensated congestive heart failure
  • Subject who received more than 24 hours of an antibacterial drug for the current infection
  • Patient who requires Intensive Care Unit (ICU) management [In case subjects who don't correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded]
  • Patients with infections other than pneumonia or secondary infection of chronic pulmonary disease
  • Lung abscess, or empyema
  • Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis
  • Known or suspected bacteremia secondary to Staphylococcus aureus
  • Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia
  • Infection that necessitates the use of a concomitant antibacterial agent in addition to study medication [excluding subjects with concomitant use of long-term, low-dose macrolide for chronic respiratory diseases, sulbactam sodium/ampicillin sodium (Unasyn-S) and clindamycin (Dalacin-S)]
  • Known bronchial obstruction or a history of post-obstructive pneumonia
  • Known primary lung cancer
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01561794
15992
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP