Tygacil Drug Use Investigation | Clinical Trial

Key information

Conditions

Intra-Abdominal Infections Infections Intraabdominal Infections Skin Disease, Infectious Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients who are prescribed tigecycline (Tygacil).

Exclusion criteria

Subject who have not been prescribed tigecycline (Tygacil).

Treatment and study plan

Tigecycline (Tygacil)

Drug

Tigecycline 50 mg intravenously. Therapy conducted according to Japanese LPD of Tygacil. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment.

Other names: Tygacil, Tigecycline

Primary outcomes

Number of Participants With Adverse Drug Reaction (ADR)

Time frame: 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 outcomes

Clinical Response Rate

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)

Acronym: TIGER

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Feb 12, 2013
Registry last updated: Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed