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

NCT ID: NCT01561794

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-03-31

Brief Summary

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.

Conditions

Pneumonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciprofloxacin

Group Type: EXPERIMENTAL

Ciprofloxacin (Cipro, BAYQ3939)

Intervention Type: DRUG

(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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Nagakute, Aichi-ken, Japan

Kobe, Hyōgo, Japan

Kahoku-gun, Ishikawa-ken, Japan

Yokohama, Kanagawa, Japan

Isahaya, Nagasaki, Japan

Isahaya, Nagasaki, Japan

Nagasaki, Nagasaki, Japan

Nagasaki, Nagasaki, Japan

Nagasaki, Nagasaki, Japan

Sasebo, Nagasaki, Japan

Unzen, Nagasaki, Japan

Niigata, Niigata, Japan

Niigata, Niigata, Japan

Niigata, Niigata, Japan

Yufu, Oita Prefecture, Japan

Okayama, Okayama-ken, Japan

Kishiwada, Osaka, Japan

Osaka, Osaka, Japan

Ureshino, Saga-ken, Japan

Hamamatsu, Shizuoka, Japan

Countries

Japan

Other Identifiers

15992

Identifier Type: -

Identifier Source: org_study_id