Tygacil Drug Use Investigation

Intra-Abdominal Infections Clinical Trial

— TIGER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789905
• Other study ID #: B1811187
• Status: Completed
• Start date: April 15, 2013
• Est. completion date: June 16, 2017

Study information

• Verified date: January 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 16, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who are prescribed tigecycline (Tygacil).

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intra-Abdominal Infections
• Intraabdominal Infections
• Skin Disease, Infectious
• Skin Diseases
• Skin Diseases, Infectious

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up until 14 days from the start date and 28 days from the end of the observation period
Secondary	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.	Within 14 days from the start date
Secondary	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.	Within 28 days post-treatment

External Links

•   To obtain contact information for a study center near you, click here.