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

Primary Purpose

Pneumonia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Ciprofloxacin (Cipro, BAYQ3939)

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Ciprofloxacin, Bacterial pneumonia, Community Acquired Pneumonia (CAP), Hospital Acquired Pneumonia (HAP), Secondary infection of chronic respiratory disease, 400 mg BID/TID

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ciprofloxacin

Arm Description

Outcomes

Primary Outcome Measures

Safety variables will be summarized using descriptive statistics based on adverse events collection

AUC (Area under the blood concentration/time curve)

Cmax (Maximum observed concentration)

AUC/MIC (Minimum inhibitory concentration)

Cmax/MIC

AUC/MPC (Mutant prevention concentration)

Cmax/MPC

Secondary Outcome Measures

Clinical response rate based on resolution of signs and symptoms

Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients

Test of cure rate based on resolution of signs, symptoms, and the clinical response

Full Information

NCT ID

NCT01561794

First Posted

March 21, 2012

Last Updated

April 24, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01561794

Brief Title

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

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ciprofloxacin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin (Cipro, BAYQ3939)

Intervention Description

(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.

Primary Outcome Measure Information:

Title

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

Title

AUC (Area under the blood concentration/time curve)

Time Frame