Retrospective Transverse Observational Study Of Previous Study (Initial Protocol, B1811030)

Completed

• Conditions: Survival Status at Day 30 After the Last Intake

• Registration Number: NCT01840319
• Lead Sponsor: Pfizer

Brief Summary

The goal of this retrospective observational study is to collect only status survival data 30 days after the last dose of treatment of patients included in the initial protocol WYETH 3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-10
• Results First Submitted: 2014-06-27
• Results First Submitted QC: 2014-06-27
• Last Update Submitted: 2014-06-27
• Results First Posted: 2014-07-28
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• All patients included in the previous study WYETH 3074A1-4448 then Pfizer B1811030 for which mortality status was not known at the closure of this previous study

Exclusion Criteria

• Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer B1811030.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline	30 days after last dose of Tigecycline (Day 108)	Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants' data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Toulouse, France