Clinical trial NCT01561794: A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: Ciprofloxacin
Bacterial pneumonia
Community Acquired Pneumonia (CAP)
Hospital Acquired Pneumonia (HAP)
Secondary infection of chronic respiratory disease
400 mg BID/TID
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: Up to 30 (±5) days after the end of treatment
measure: AUC (Area under the blood concentration/time curve)
timeFrame: Within 0-24 hours and 48-72 hours after the first study drug administration
measure: Cmax (Maximum observed concentration)
timeFrame: Within 0-24 hours and 48-72 hours after the first study drug administration
measure: AUC/MIC (Minimum inhibitory concentration)
timeFrame: Within 0-24 hours and 48-72 hours after the first study drug administration
measure: Cmax/MIC
timeFrame: Within 0-24 hours and 48-72 hours after the first study drug administration
measure: AUC/MPC (Mutant prevention concentration)
timeFrame: Within 0-24 hours and 48-72 hours after the first study drug administration
measure: Cmax/MPC
timeFrame: Within 0-24 hours and 48-72 hours after the first study drug administration
Secondary outcomes:
measure: Clinical response rate based on resolution of signs and symptoms
timeFrame: Up to 13 days after the first study drug administration
measure: Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients
timeFrame: Up to 23 days after the first study drug administration
measure: Test of cure rate based on resolution of signs, symptoms, and the clinical response
timeFrame: Up to 23 days after the first study drug administration
Other outcomes:
Locations:
city: Nagakute
country: Japan
state: Aichi
city: Kobe
country: Japan
state: Hyogo
city: Kahoku-gun
country: Japan
state: Ishikawa
city: Yokohama
country: Japan
state: Kanagawa
city: Isahaya
country: Japan
state: Nagasaki
city: Isahaya
country: Japan
state: Nagasaki
city: Sasebo
country: Japan
state: Nagasaki
city: Unzen
country: Japan
state: Nagasaki
city: Yufu
country: Japan
state: Oita
city: Kishiwada
country: Japan
state: Osaka
city: Ureshino
country: Japan
state: Saga
city: Hamamatsu
country: Japan
state: Shizuoka
city: Nagasaki
country: Japan
city: Nagasaki
country: Japan
city: Nagasaki
country: Japan
city: Niigata
country: Japan
city: Niigata
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: