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

NCT01561794 | Completed Phase 3

• 1 other identifier: 15992
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 20

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

Keywords

Ciprofloxacin; Bacterial pneumonia; Community Acquired Pneumonia (CAP); Hospital Acquired Pneumonia (HAP); Secondary infection of chronic respiratory disease; 400 mg BID/TID

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• 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

Study Arms (1)

Ciprofloxacin

EXPERIMENTAL

Drug: Ciprofloxacin (Cipro, BAYQ3939)

Interventions

Ciprofloxacin (Cipro, BAYQ3939) 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.

Ciprofloxacin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (20)

Unknown Facility

Nagakute, Aichi-ken, 480-1195, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0047, Japan

Location

Unknown Facility

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 232-0024, Japan

Location

Unknown Facility

Isahaya, Nagasaki, 854-8501, Japan

Location

Unknown Facility

Isahaya, Nagasaki, 859-0497, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, 850-8555, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, 852-8501, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, 852-8511, Japan

Location

Unknown Facility

Sasebo, Nagasaki, 857-8511, Japan

Location

Unknown Facility

Unzen, Nagasaki, 854-0301, Japan

Location

Unknown Facility

Niigata, Niigata, 950-1197, Japan

Location

Unknown Facility

Niigata, Niigata, 950-2087, Japan

Location

Unknown Facility

Niigata, Niigata, 951-8520, Japan

Location

Unknown Facility

Yufu, Oita Prefecture, 879-5593, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 700-8607, Japan

Location

Unknown Facility

Kishiwada, Osaka, 596-8501, Japan

Location

Unknown Facility

Osaka, Osaka, 543-0035, Japan

Location

Unknown Facility

Ureshino, Saga-ken, 843-0393, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, 434-8511, Japan

Location

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial; Community-Acquired Pneumonia; Healthcare-Associated Pneumonia

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Community-Acquired Infections; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 23, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

JP (20)