check_circleStudy Completed

Pneumonia

Bayer Identifier:

15992

ClinicalTrials.gov Identifier:

NCT01561794

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Phase III study to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of BAYQ3939 in patients with bacterial pneumonia

Trial 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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - 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.
  • - 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

Trial summary

Enrollment Goal
44
Trial Dates
May 2012 - March 2015
Phase
Phase 3
Could I Receive a placebo
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Nagasaki University HospitalNagasaki, 852-8501, Japan
Completed
Shinrakuen HospitalNiigata, 950-2087, Japan
Completed
Niigata City General HospitalNiigata, 950-1197, Japan
Terminated
Kishiwada City HospitalKishiwada, 596-8501, Japan
Completed
Osaka Police HospitalOsaka, 543-0035, Japan
Completed
Niigata University Medical and Dental HospitalNiigata, 951-8520, Japan
Completed
Japan Community Health Care Organization Isahaya General HPIsahaya, 854-8501, Japan
Completed
The Japanese Red Cross Nagasaki Genbaku HospitalNagasaki, 852-8511, Japan
Completed
Aichi Medical University HospitalNagakute, 480-1195, Japan
Completed
National Hospital Organization Tenryu HospitalHamamatsu, 434-8511, Japan
Completed
Japanese Red Cross Nagasaki Genbaku Isahaya HospitalIsahaya, 859-0497, Japan
Completed
Aino Memorial HospitalUnzen, 854-0301, Japan
Completed
National Hospital Organization Ureshino Medical CenterUreshino, 843-0393, Japan
Completed
Sasebo City General HospitalSasebo, 857-8511, Japan
Terminated
Nagasaki Harbor Medical Center City HospitalNagasaki, 850-8555, Japan
Completed
Kanazawa Medical Univ HospitalKahoku-gun, 920-0293, Japan
Completed
Yokohama City University Medical CenterYokohama, 232-0024, Japan
Completed
Kobe City Medical Center General HospitalKobe, 650-0047, Japan
Completed
Japanese Red Cross Okayama HospitalOkayama, 700-8607, Japan
Completed
Oita University HospitalYufu, 879-5593, Japan

Primary Outcome

  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    Up to 30 (±5) days after the end of treatment
    enhanced_encryption
    Safety Issue:
    Yes
  • AUC (Area under the blood concentration/time curve)
    date_rangeTime Frame:
    Within 0-24 hours and 48-72 hours after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Cmax (Maximum observed concentration)
    date_rangeTime Frame:
    Within 0-24 hours and 48-72 hours after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • AUC/MIC (Minimum inhibitory concentration)
    date_rangeTime Frame:
    Within 0-24 hours and 48-72 hours after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/MIC
    date_rangeTime Frame:
    Within 0-24 hours and 48-72 hours after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • AUC/MPC (Mutant prevention concentration)
    date_rangeTime Frame:
    Within 0-24 hours and 48-72 hours after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Cmax/MPC
    date_rangeTime Frame:
    Within 0-24 hours and 48-72 hours after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Clinical response rate based on resolution of signs and symptoms
    date_rangeTime Frame:
    Up to 13 days after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients
    date_rangeTime Frame:
    Up to 23 days after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Test of cure rate based on resolution of signs, symptoms, and the clinical response
    date_rangeTime Frame:
    Up to 23 days after the first study drug administration
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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