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

Phase 3

Completed

• Conditions: Pneumonia
• Interventions: Drug: Ciprofloxacin (Cipro, BAYQ3939)

• Registration Number: NCT01561794
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Study Start: 2012-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin	Ciprofloxacin (Cipro, BAYQ3939)	-

Primary Outcome Measures

Name	Time	Method
Safety variables will be summarized using descriptive statistics based on adverse events collection	Up to 30 (±5) days after the end of treatment
AUC (Area under the blood concentration/time curve)	Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax/MPC	Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax (Maximum observed concentration)	Within 0-24 hours and 48-72 hours after the first study drug administration
AUC/MIC (Minimum inhibitory concentration)	Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax/MIC	Within 0-24 hours and 48-72 hours after the first study drug administration
AUC/MPC (Mutant prevention concentration)	Within 0-24 hours and 48-72 hours after the first study drug administration

Secondary Outcome Measures

Name	Time	Method
Clinical response rate based on resolution of signs and symptoms	Up to 13 days after the first study drug administration
Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients	Up to 23 days after the first study drug administration
Test of cure rate based on resolution of signs, symptoms, and the clinical response	Up to 23 days after the first study drug administration