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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

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

Condition or disease Intervention/treatment
Intra-Abdominal Infections Skin Disease, Infectious Drug: Tigecycline (Tygacil)

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Study Type : Observational
Actual Enrollment : 116 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline

Group/Cohort Intervention/treatment
Tigecycline (Tygacil)
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involving B1811187 prescribes the tigecycline (Tygacil).
Criteria

Inclusion Criteria:

  • All patients who are prescribed tigecycline (Tygacil).

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] May 25, 2016
Statistical Analysis Plan  [PDF] August 29, 2017

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01789905    
Other Study ID Numbers: B1811187
First Posted: February 12, 2013    Key Record Dates
Results First Posted: December 24, 2018
Last Update Posted: February 6, 2019
Last Verified: January 2019
Individual Participant Data (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.
Keywords provided by Pfizer:
Tygacil
Tigecycline
Post marketing surveillance
Japanese
Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Intraabdominal Infections
Skin Diseases, Infectious
Skin Diseases
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action