Tygacil Drug Use Investigation

Completed

• Conditions: Intra-Abdominal Infections; Skin Disease, Infectious
• Interventions: Drug: Tigecycline (Tygacil)

• Registration Number: NCT01789905
• Lead Sponsor: Pfizer

Brief Summary

Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Study Start: 2013-04-15
• Primary Completion: 2017-06-16
• Study Completion: 2017-06-16
• Results First Submitted: 2018-06-12
• Results First Submitted QC: 2018-06-12
• Results First Posted: 2018-12-24
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• All patients who are prescribed tigecycline (Tygacil).

Exclusion Criteria

• Subject who have not been prescribed tigecycline (Tygacil).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tigecycline (Tygacil)	Tigecycline (Tygacil)	Subjects who are treated with tigecycline

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reaction (ADR)	Up until 14 days from the start date and 28 days from the end of the observation period	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician.

Secondary Outcome Measures

Name	Time	Method
Clinical Response Rate	Within 14 days from the start date	Clinical response rate, which was defined as the percentage of participants who achieved clinical response as "effective" over the total number of assessable effectiveness analysis population("effective" plus "ineffective",) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as "effective," "ineffective," or "indeterminate" by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings.
Clinical Response Rate of Cure	Within 28 days post-treatment	The cure rate, which was defined as the percentage of participants who were assessed as "cure" over the total number of assessable effectiveness analysis population ("cure" plus "failure"), was presented along with two-sided 95% CI. Clinical response of cure was assessed as "cure," "failure," or "indeterminate" by the physician within 28 days post-treatment.