French Study In ICU Patients Treated With Tigecycline

Status Completed

Clinical Trial Summary

This study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned. Data will be collected only from subjects providing informed consent.

Clinical Trial Description

Healthcare visit.

Extension Rationale:

In order to perform the necessary corrective actions required and to secure database consistency, we request an extension for posting of Basic Results due 26-May-2011 for protocol 3074A1-4448 (B1811030), NCT00799591. Our proposed submission date is 14-Sept-2011.

Pfizer acquired Wyeth on October 16, 2009. With regard to this study, our reconciliation of data identified some discrepancies in data listed in the Project database (managed by the CRO) and the Safety Database (managed by Pfizer). We are taking corrective action which involves: sending queries to investigators, collecting corrective signed forms, and implementing changes within the database. We are requesting this extension to complete that work so that the data can be treated as final and the CSR can be completed. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Bacterial Infections

Clinical Trial Details

NCT number	NCT00799591
Study type	Observational
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status	Completed
Phase	N/A
Start date	September 2008
Completion date	May 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03726216` - Xydalba Utilization Registry in France
Completed	`NCT03605498` - OR PathTrac (Tracking Intra-operative Bacterial Transmission)
Withdrawn	`NCT05269121` - Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections	Phase 1/Phase 2
Completed	`NCT02541695` - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli	N/A
Recruiting	`NCT02074865` - Children's Antibiotic Resistant Infections in Low Income Countries	N/A
Completed	`NCT01932034` - Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software	N/A
Completed	`NCT01689207` - To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)	Phase 1
Completed	`NCT01412801` - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings	Phase 2
Not yet recruiting	`NCT01159470` - The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children	N/A
Completed	`NCT00983255` - Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)	Phase 1
Completed	`NCT00678106` - Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections	Phase 1
Completed	`NCT01074775` - Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection	N/A
Completed	`NCT00478855` - Tazocin Intervention Study	Phase 4
Terminated	`NCT00431028` - Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery	Phase 1/Phase 2
Not yet recruiting	`NCT03634904` - Serum Ceftazidime Concentrations in Hemodialysis Patients	N/A
Recruiting	`NCT05684705` - Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100	Phase 1
Recruiting	`NCT03858387` - PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
Enrolling by invitation	`NCT04764058` - Efficacy and Safety of Colistin Based Antibiotic Therapy	Phase 1/Phase 2
Recruiting	`NCT06319235` - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®	Phase 1/Phase 2
Completed	`NCT03332732` - VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers	Phase 1