Tygacil Drug Use Investigation

N/ACompletedNCT01789905

Pfizer116 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

116

Conditions

Intra-Abdominal Infections Skin Disease, Infectious

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All patients who are prescribed tigecycline (Tygacil). Exclusion Criteria: * Subject who have not been prescribed tigecycline (Tygacil).

Outcomes

Primary Outcomes

Number of Participants With Adverse Drug Reaction (ADR)

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.

Time frame: Up until 14 days from the start date and 28 days from the end of the observation period

Secondary Outcomes

Clinical Response Rate

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.

Time frame: Within 14 days from the start date

Clinical Response Rate of Cure

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.

Time frame: Within 28 days post-treatment

Data from ClinicalTrials.gov

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