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. (see Contacts and Locations)
Verified October 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01561794
First received: March 21, 2012
Last updated: October 16, 2014
Last verified: October 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: 46
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
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: NCT01561794

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
Japan
Recruiting
Nagakute, Aichi, Japan, 480-1195
Recruiting
Kobe, Hyogo, Japan, 650-0047
Recruiting
Kahoku-gun, Ishikawa, Japan, 920-0293
Recruiting
Yokohama, Kanagawa, Japan, 232-0024
Recruiting
Isahaya, Nagasaki, Japan, 859-0497
Recruiting
Isahaya, Nagasaki, Japan, 854-8501
Recruiting
Sasebo, Nagasaki, Japan, 857-8511
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
Not yet recruiting
Nagasaki, Japan, 852-8501
Not yet recruiting
Nagasaki, Japan, 850-8555
Recruiting
Nagasaki, Japan, 852-8511
Recruiting
Niigata, Japan, 950-1197
Not yet recruiting
Niigata, Japan, 950-2087
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: October 16, 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
Pneumonia, Bacterial
Respiration Disorders
Respiratory Tract Diseases
Bacterial Infections
Lung Diseases
Respiratory Tract Infections
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014