PneumoniaPhase 3NCT01561794
A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
A Phase 3 study testing Ciprofloxacin (Cipro, BAYQ3939) in people with Pneumonia, run by Bayer at 20 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Ciprofloxacin (Cipro, BAYQ3939)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 20 sitesJapan
- Study dates
- May 2012to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Study site
Hamamatsu, Shizuoka, 434-8511
Study site
Isahaya, Nagasaki, 854-8501
Study site
Isahaya, Nagasaki, 859-0497
Study site
Kahoku-gun, Ishikawa-ken, 920-0293
Study site
Kishiwada, Osaka, 596-8501
Study site
Kobe, Hyōgo, 650-0047
Study site
Nagakute, Aichi-ken, 480-1195
Study site
Nagasaki, Nagasaki, 850-8555
Study site
Nagasaki, Nagasaki, 852-8501
Study site
Nagasaki, Nagasaki, 852-8511
Study site
Niigata, Niigata, 950-1197
Study site
Niigata, Niigata, 950-2087
Study site
Niigata, Niigata, 951-8520
Study site
Okayama, Okayama-ken, 700-8607
Study site
Osaka, Osaka, 543-0035
Study site
Sasebo, Nagasaki, 857-8511
Study site
Unzen, Nagasaki, 854-0301
Study site
Ureshino, Saga-ken, 843-0393
Study site
Yokohama, Kanagawa, 232-0024
Study site
Yufu, Oita Prefecture, 879-5593
About this study
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
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
- Being tested
- Ciprofloxacin (Cipro, BAYQ3939)
- Keywords
- Ciprofloxacin, Bacterial pneumonia, Community Acquired Pneumonia (CAP), Hospital Acquired Pneumonia (HAP), Secondary infection of chronic respiratory disease, 400 mg BID/TID
- Medical subject headings
- Pneumonia, Pneumonia, Bacterial, Community-Acquired Pneumonia, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Experimental | Not described Receives: Drug: Ciprofloxacin (Cipro, BAYQ3939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables will be summarized using descriptive statistics based on adverse events collection
Measured: Up to 30 (±5) days after the end of treatment
AUC (Area under the blood concentration/time curve)
Measured: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax (Maximum observed concentration)
Measured: Within 0-24 hours and 48-72 hours after the first study drug administration
AUC/MIC (Minimum inhibitory concentration)
Measured: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax/MIC
Measured: Within 0-24 hours and 48-72 hours after the first study drug administration
AUC/MPC (Mutant prevention concentration)
Measured: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax/MPC
Measured: 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
Measured: Up to 13 days after the first study drug administration
Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients
Measured: Up to 23 days after the first study drug administration
Test of cure rate based on resolution of signs, symptoms, and the clinical response
Measured: Up to 23 days after the first study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561794
- Sponsor's protocol ID
- 15992
- Status last verified
- Apr 2015
- First submitted
- 21 Mar 2012
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01561794
- Acronym / sponsor ID
- 15992
- Conditions
- Pneumonia
- Keywords
- Ciprofloxacin, Bacterial pneumonia, Community Acquired Pneumonia (CAP), Hospital Acquired Pneumonia (HAP), Secondary infection of chronic respiratory disease, 400 mg BID/TID
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Experimental | Drug: Ciprofloxacin (Cipro, BAYQ3939) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Ciprofloxacin |
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
AUC (Area under the blood concentration/time curve)
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax (Maximum observed concentration)
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
AUC/MIC (Minimum inhibitory concentration)
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax/MIC
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
AUC/MPC (Mutant prevention concentration)
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
Cmax/MPC
Time frame: Within 0-24 hours and 48-72 hours after the first study drug administration
3 secondary outcomes
Clinical response rate based on resolution of signs and symptoms
Time frame: Up to 13 days after the first study drug administration
Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients
Time frame: Up to 23 days after the first study drug administration
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin (Cipro, BAYQ3939) in people with Pneumonia, run by Bayer at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.