To retrospectively collect the effectiveness and safety information of tigecycline related to their appropriate use in daily practice.
- All patients who are prescribed tigecycline (Tygacil).
- Subject who have been prescribed tigecycline (Tygacil).
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Tygacil Drug Use Investigation | ||||
| Official Title | Tygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.) | ||||
| Brief Summary | Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The patients whom an investigator involving B1811187 prescribes the tigecycline (Tygacil). | ||||
| Condition |
| ||||
| 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. Other Name: Tygacil, Tigecycline | ||||
| Study Groups/Cohorts | Tigecycline (Tygacil) Subjects who are treated with tigecycline Intervention: Drug: Tigecycline (Tygacil) | ||||
| Publications * | Not Provided | ||||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment | 116 | ||||
| Original Estimated Enrollment | 100 | ||||
| Actual Study Completion Date | June 16, 2017 | ||||
| Actual Primary Completion Date | June 16, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT01789905 | ||||
| Other Study ID Numbers | B1811187 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | January 2019 | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
