Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01561794
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2012-03-21
Brief Title:
A Phase III Study to Evaluate the Safety Efficacy and PharmacokineticsPharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
Sponsor:
Bayer
Organization:
Bayer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None