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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01561794

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: Ciprofloxacin (Cipro, BAYQ3939)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ciprofloxacin	Drug: 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.

Arm

Intervention/Treatment

Experimental: Ciprofloxacin

Drug: 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.

Outcome Measures

Primary Outcome Measures

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 (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]
Cmax/MPC [Within 0-24 hours and 48-72 hours after the first study drug administration]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Nagakute	Aichi	Japan	480-1195
2	Kobe	Hyogo	Japan	650-0047
3	Kahoku-gun	Ishikawa	Japan	920-0293
4	Yokohama	Kanagawa	Japan	232-0024
5	Isahaya	Nagasaki	Japan	854-8501
6	Isahaya	Nagasaki	Japan	859-0497
7	Sasebo	Nagasaki	Japan	857-8511
8	Unzen	Nagasaki	Japan	854-0301
9	Yufu	Oita	Japan	879-5593
10	Kishiwada	Osaka	Japan	596-8501
11	Ureshino	Saga	Japan	843-0393
12	Hamamatsu	Shizuoka	Japan	434-8511
13	Nagasaki		Japan	850-8555
14	Nagasaki		Japan	852-8501
15	Nagasaki		Japan	852-8511
16	Niigata		Japan	950-1197
17	Niigata		Japan	950-2087
18	Niigata		Japan	951-8520
19	Okayama		Japan	700-8607
20	Osaka		Japan	543-0035