Study 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

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

Trial Dates

May 2012 - March 2015

Phase

Phase 3

Could I Receive a placebo

Products

Cipro IV (Ciprofloxacin, BAYQ3939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Terminated	Nagasaki University Hospital	Nagasaki, 852-8501, Japan
Completed	Shinrakuen Hospital	Niigata, 950-2087, Japan
Completed	Niigata City General Hospital	Niigata, 950-1197, Japan
Terminated	Kishiwada City Hospital	Kishiwada, 596-8501, Japan
Completed	Osaka Police Hospital	Osaka, 543-0035, Japan
Completed	Niigata University Medical and Dental Hospital	Niigata, 951-8520, Japan
Completed	Japan Community Health Care Organization Isahaya General HP	Isahaya, 854-8501, Japan
Completed	The Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki, 852-8511, Japan
Completed	Aichi Medical University Hospital	Nagakute, 480-1195, Japan
Completed	National Hospital Organization Tenryu Hospital	Hamamatsu, 434-8511, Japan
Completed	Japanese Red Cross Nagasaki Genbaku Isahaya Hospital	Isahaya, 859-0497, Japan
Completed	Aino Memorial Hospital	Unzen, 854-0301, Japan
Completed	National Hospital Organization Ureshino Medical Center	Ureshino, 843-0393, Japan
Completed	Sasebo City General Hospital	Sasebo, 857-8511, Japan
Terminated	Nagasaki Harbor Medical Center City Hospital	Nagasaki, 850-8555, Japan
Completed	Kanazawa Medical Univ Hospital	Kahoku-gun, 920-0293, Japan
Completed	Yokohama City University Medical Center	Yokohama, 232-0024, Japan
Completed	Kobe City Medical Center General Hospital	Kobe, 650-0047, Japan
Completed	Japanese Red Cross Okayama Hospital	Okayama, 700-8607, Japan
Completed	Oita University Hospital	Yufu, 879-5593, Japan

Primary Outcome

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

Secondary Outcome

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

Additional Information

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