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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01561794
First received: March 21, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pneumonia
Drug: Ciprofloxacin (Cipro, BAYQ3939)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • AUC (Area under the blood concentration/time curve) [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ] [ Designated as safety issue: No ]
  • Cmax (Maximum observed concentration) [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ] [ Designated as safety issue: No ]
  • AUC/MIC (Minimum inhibitory concentration) [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ] [ Designated as safety issue: No ]
  • Cmax/MIC [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ] [ Designated as safety issue: No ]
  • AUC/MPC (Mutant prevention concentration) [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ] [ Designated as safety issue: No ]
  • Cmax/MPC [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response rate based on resolution of signs and symptoms [ Time Frame: Up to 13 days after the first study drug administration ] [ Designated as safety issue: No ]
  • Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients [ Time Frame: Up to 23 days after the first study drug administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciprofloxacin 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.


  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561794

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Japan
Recruiting
Nagakute, Aichi, Japan, 480-1195
Recruiting
Kobe, Hyogo, Japan, 650-0047
Recruiting
Kahoku-gun, Ishikawa, Japan, 920-0293
Not yet recruiting
Yokohama, Kanagawa, Japan, 232-0024
Recruiting
Isahaya, Nagasaki, Japan, 859-0497
Not yet recruiting
Isahaya, Nagasaki, Japan, 854-8501
Recruiting
Sasebo, Nagasaki, Japan, 857-8511
Not yet recruiting
Unzen, Nagasaki, Japan, 854-0301
Recruiting
Yufu, Oita, Japan, 879-5593
Not yet recruiting
Kishiwada, Osaka, Japan, 596-8501
Recruiting
Ureshino, Saga, Japan, 843-0393
Recruiting
Hamamatsu, Shizuoka, Japan, 434-8511
Recruiting
Nagasaki, Japan, 852-8511
Not yet recruiting
Nagasaki, Japan, 852-8501
Not yet recruiting
Nagasaki, Japan, 850-8555
Recruiting
Niigata, Japan, 950-1197
Not yet recruiting
Niigata, Japan, 950-2087
Not yet recruiting
Niigata, Japan, 951-8520
Recruiting
Okayama, Japan, 700-8607
Recruiting
Osaka, Japan, 543-0035
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01561794     History of Changes
Other Study ID Numbers: 15992
Study First Received: March 21, 2012
Last Updated: April 14, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Ciprofloxacin
Bacterial pneumonia
Community Acquired Pneumonia (CAP)
Hospital Acquired Pneumonia (HAP)
Secondary infection of chronic respiratory disease
400 mg BID/TID

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Respiration Disorders
Respiratory Tract Diseases
Bacterial Infections
Lung Diseases
Respiratory Tract Infections
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014