Tygacil Drug Use Investigation

NCT01789905 | Completed Results

• 1 other identifier: B1811187
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Intra-Abdominal Infections; Skin Disease, Infectious

Keywords

Tygacil; Tigecycline; Post marketing surveillance; Japanese; Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Response Rate

  Within 14 days from the start date

• Clinical Response Rate of Cure

  Within 28 days post-treatment

Study Arms (1)

Tigecycline (Tygacil)

Subjects who are treated with tigecycline

Drug: Tigecycline (Tygacil)

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.

Also known as: Tygacil, Tigecycline

Tigecycline (Tygacil)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving B1811187 prescribes the tigecycline (Tygacil).

You may qualify if:

• All patients who are prescribed tigecycline (Tygacil).

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Intraabdominal Infections; Skin Diseases, Infectious; Infections

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 12, 2013
• Study Start: April 15, 2013
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: February 6, 2019
• Results First Posted: December 24, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share