check_circleStudy Completed
Pneumonia
Bayer Identifier:
15992
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A Phase III study to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of BAYQ3939 in patients with bacterial pneumonia
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
20 - N/ATrial summary
Enrollment Goal
44Trial Dates
May 2012 - March 2015Phase
Phase 3Could I Receive a placebo
NoProducts
Cipro IV (Ciprofloxacin, BAYQ3939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Nagasaki University Hospital | Nagasaki, 852-8501, Japan |
Completed | Shinrakuen Hospital | Niigata, 950-2087, Japan |
Completed | Niigata City General Hospital | Niigata, 950-1197, Japan |
Terminated | Kishiwada City Hospital | Kishiwada, 596-8501, Japan |
Completed | Osaka Police Hospital | Osaka, 543-0035, Japan |
Completed | Niigata University Medical and Dental Hospital | Niigata, 951-8520, Japan |
Completed | Japan Community Health Care Organization Isahaya General HP | Isahaya, 854-8501, Japan |
Completed | The Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki, 852-8511, Japan |
Completed | Aichi Medical University Hospital | Nagakute, 480-1195, Japan |
Completed | National Hospital Organization Tenryu Hospital | Hamamatsu, 434-8511, Japan |
Completed | Japanese Red Cross Nagasaki Genbaku Isahaya Hospital | Isahaya, 859-0497, Japan |
Completed | Aino Memorial Hospital | Unzen, 854-0301, Japan |
Completed | National Hospital Organization Ureshino Medical Center | Ureshino, 843-0393, Japan |
Completed | Sasebo City General Hospital | Sasebo, 857-8511, Japan |
Terminated | Nagasaki Harbor Medical Center City Hospital | Nagasaki, 850-8555, Japan |
Completed | Kanazawa Medical Univ Hospital | Kahoku-gun, 920-0293, Japan |
Completed | Yokohama City University Medical Center | Yokohama, 232-0024, Japan |
Completed | Kobe City Medical Center General Hospital | Kobe, 650-0047, Japan |
Completed | Japanese Red Cross Okayama Hospital | Okayama, 700-8607, Japan |
Completed | Oita University Hospital | Yufu, 879-5593, Japan |
Primary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events collectiondate_rangeTime Frame:Up to 30 (±5) days after the end of treatmentenhanced_encryptionYesSafety Issue:
- AUC (Area under the blood concentration/time curve)date_rangeTime Frame:Within 0-24 hours and 48-72 hours after the first study drug administrationenhanced_encryptionNoSafety Issue:
- Cmax (Maximum observed concentration)date_rangeTime Frame:Within 0-24 hours and 48-72 hours after the first study drug administrationenhanced_encryptionNoSafety Issue:
- AUC/MIC (Minimum inhibitory concentration)date_rangeTime Frame:Within 0-24 hours and 48-72 hours after the first study drug administrationenhanced_encryptionNoSafety Issue:
- Cmax/MICdate_rangeTime Frame:Within 0-24 hours and 48-72 hours after the first study drug administrationenhanced_encryptionNoSafety Issue:
- AUC/MPC (Mutant prevention concentration)date_rangeTime Frame:Within 0-24 hours and 48-72 hours after the first study drug administrationenhanced_encryptionNoSafety Issue:
- Cmax/MPCdate_rangeTime Frame:Within 0-24 hours and 48-72 hours after the first study drug administrationenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Clinical response rate based on resolution of signs and symptomsdate_rangeTime Frame:Up to 13 days after the first study drug administrationenhanced_encryptionNoSafety Issue:
- Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patientsdate_rangeTime Frame:Up to 23 days after the first study drug administrationenhanced_encryptionNoSafety Issue:
- Test of cure rate based on resolution of signs, symptoms, and the clinical responsedate_rangeTime Frame:Up to 23 days after the first study drug administrationenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1