Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360607
Status:
COMPLETED
Last Update Posted:
2008-12-02
First Post:
2006-08-03
Brief Title:
A Comparative Phase IV Study Evaluating Efficacy Safety Of MagnexCefoperazone-Sulbactam In Intraabdominal Infections
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Open Label Multicentre Phase Iv Study To Evaluate The Efficacy And Safety Of Magnex Cefoperazone-Sulbactam In Comparison With Ceftazidime Plus Amikacin And Metronidazole In The Treatment Of Intra-Abdominal Infections
Status:
COMPLETED
Status Verified Date:
2008-12
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:
Intra-abdominal infections are often polymicrobial and include aerobic as well as anaerobic bacteria Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides fragilis which are the commonest organisms known to cause such infections Combinations of a third-generation cephalosporin an aminoglycoside and metronidazole are often used to treat such infections in surgical settings An alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor combination Magnex cefoperazone- sulbactam is one such combination which has been shown to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the management of intra-abdominal infections The combination of ceftazidime amikacin and metronidazole has been chosen as a comparator regimen because of its broad coverage of Gram-negative and anaerobic organisms found in such conditions
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