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Tygacil Drug Use Investigation

Last updated on November 16, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Intra-Abdominal Infections, Infectious Skin Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- All patients who are prescribed tigecycline (Tygacil).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subject who have been prescribed tigecycline (Tygacil).

NCT01789905
Pfizer
Active, not recruiting
Tygacil Drug Use Investigation

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cIAIs Complicated Intra-Abdominal Infections
NCT02655419
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief TitleTygacil Drug Use Investigation
Official TitleTygacil Drug Use Investigation (Tigecycline Evaluation Study For Safety And Effectiveness In Patient Infected With Multi-Drug Resistance.)
Brief SummarySecondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving B1811187 prescribes the tigecycline (Tygacil).
Condition
  • Intra-Abdominal Infections
  • Skin Disease, Infectious
InterventionDrug: 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/CohortsTigecycline (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 StatusCompleted
Actual Enrollment
 (submitted: August 16, 2017)
116
Original Estimated Enrollment
 (submitted: February 8, 2013)
100
Actual Study Completion DateJune 16, 2017
Actual Primary Completion DateJune 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01789905
Other Study ID NumbersB1811187
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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