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Trial record 1 of 1 for:    NCT01789905
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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 8, 2013
First Posted Date February 12, 2013
Results First Submitted Date June 12, 2018
Results First Posted Date December 24, 2018
Last Update Posted Date February 6, 2019
Actual Study Start Date April 15, 2013
Actual Primary Completion Date June 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2018)
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.
Original Primary Outcome Measures
 (submitted: February 8, 2013)
Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 14 days ]
Change History Complete list of historical versions of study NCT01789905 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 17, 2019)
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
  • Intra-Abdominal Infections
  • Skin Disease, 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.
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
 (submitted: August 16, 2017)
116
Original Estimated Enrollment
 (submitted: February 8, 2013)
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:

  • All patients who are prescribed tigecycline (Tygacil).

Exclusion Criteria:

  • Subject who have not been prescribed tigecycline (Tygacil).
Sex/Gender
Sexes Eligible for Study: All
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
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019