A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3… (NCT01561794) | Clinical Trial Compass
CompletedPhase 3
A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
Japan44 participantsStarted 2012-05
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety variables will be summarized using descriptive statistics based on adverse events collection
Timeframe: Up to 30 (±5) days after the end of treatment
2
AUC (Area under the blood concentration/time curve)
Timeframe: Within 0-24 hours and 48-72 hours after the first study drug administration
3
Cmax (Maximum observed concentration)
Timeframe: Within 0-24 hours and 48-72 hours after the first study drug administration
4
AUC/MIC (Minimum inhibitory concentration)
Timeframe: Within 0-24 hours and 48-72 hours after the first study drug administration
5
Cmax/MIC
Timeframe: Within 0-24 hours and 48-72 hours after the first study drug administration
6
AUC/MPC (Mutant prevention concentration)
Timeframe: Within 0-24 hours and 48-72 hours after the first study drug administration