Trial Condition(s):

Pneumonia

A Phase III study to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of BAYQ3939 in patients with bacterial pneumonia

Bayer Identifier:

15992

ClinicalTrials.gov Identifier:

NCT01561794

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
44
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Cipro IV (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Nagasaki University Hospital

Nagasaki, Japan, 852-8501

Status
Terminated
 
Locations

Shinrakuen Hospital

Niigata, Japan, 950-2087

Status
Completed
 
Locations

Niigata City General Hospital

Niigata, Japan, 950-1197

Status
Completed
 
Locations

Kishiwada City Hospital

Kishiwada, Japan, 596-8501

Status
Terminated
 
Locations

Osaka Police Hospital

Osaka, Japan, 543-0035

Status
Completed
 
Locations

Niigata University Medical and Dental Hospital

Niigata, Japan, 951-8520

Status
Completed
 
Locations

Japan Community Health Care Organization Isahaya General HP

Isahaya, Japan, 854-8501

Status
Completed
 
Locations

The Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, Japan, 852-8511

Status
Completed
 
Locations

Aichi Medical University Hospital

Nagakute, Japan, 480-1195

Status
Completed
 
Locations

National Hospital Organization Tenryu Hospital

Hamamatsu, Japan, 434-8511

Status
Completed
 
Locations

Japanese Red Cross Nagasaki Genbaku Isahaya Hospital

Isahaya, Japan, 859-0497

Status
Completed
 
Locations

Aino Memorial Hospital

Unzen, Japan, 854-0301

Status
Completed
 
Locations

National Hospital Organization Ureshino Medical Center

Ureshino, Japan, 843-0393

Status
Completed
 
Locations

Sasebo City General Hospital

Sasebo, Japan, 857-8511

Status
Completed
 
Locations

Nagasaki Harbor Medical Center City Hospital

Nagasaki, Japan, 850-8555

Status
Terminated
 
Locations

Kanazawa Medical Univ Hospital

Kahoku-gun, Japan, 920-0293

Status
Completed
 
Locations

Yokohama City University Medical Center

Yokohama, Japan, 232-0024

Status
Completed
 
Locations

Kobe City Medical Center General Hospital

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Japanese Red Cross Okayama Hospital

Okayama, Japan, 700-8607

Status
Completed
 
Locations

Oita University Hospital

Yufu, Japan, 879-5593

Status
Completed
 

Trial Design