Tygacil Drug Use Investigation (TIGER)
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|ClinicalTrials.gov Identifier: NCT01789905|
Recruitment Status : Completed
First Posted : February 12, 2013
Results First Posted : December 24, 2018
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment|
|Intra-Abdominal Infections Skin Disease, Infectious||Drug: Tigecycline (Tygacil)|
|Study Type :||Observational|
|Actual Enrollment :||116 participants|
|Official Title:||Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)|
|Actual Study Start Date :||April 15, 2013|
|Actual Primary Completion Date :||June 16, 2017|
|Actual Study Completion Date :||June 16, 2017|
Subjects who are treated with tigecycline
Drug: Tigecycline (Tygacil)
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 Name: Tygacil, Tigecycline
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789905
|Study Director:||Pfizer CT.gov Call Center||Pfizer|