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Post-Authorization Study Evaluating Safety Of Tigecycline

Last updated on November 12, 2019

FOR MORE INFORMATION
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, Soft Tissues Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Informed consent signed by patients prior to this study entry.

- 18 years of age or older at the screening visit.

- Patients with cIAI or cSSTI.

- Patients who are going to or have just been given in the previous 48 hours at least a
dose of tigecycline to treat any of the above infections.

- In the opinion of the investigator, the patient will be able to comply with the
requirements of the protocol.

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

- Known hypersensibility to tigecycline.

- Females who are pregnant, breast feeding, or at risk of pregnancy and not using a
medically acceptable form of contraception.

- Use any investigational drug within four weeks of the screening visit.

- Uncooperative patients or a history of poor compliance.

NCT00827541
Pfizer
Completed
Post-Authorization Study Evaluating Safety Of Tigecycline

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cIAIs Complicated Intra-Abdominal Infections
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18+
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Multiple Sites
Descriptive Information
Brief TitlePost-Authorization Study Evaluating Safety Of Tigecycline
Official TitleA Phase IV Pharmacovigilance, Post-Authorization Clinical Trial To Evaluate And Assess The Safety Of Tigecycline In The Approved Indications In The Usual Health Care Setting
Brief SummaryThis is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and patients' conditions, in order to assess the "real incidence" of adverse events related with tigecycline in these patients.
Detailed DescriptionSince around 50 patients were included in Spanish centers involved in the Phase III Tygacil clinical development program, and on the basis of the recruitment capacity of the centers within the predefined time window and the number of patients consenting to be enrolled in the study, the total number of patients estimated to be enrolled in the study is 500. With this sample size, it will be possible to obtain precise estimations of the incidence of particular types of adverse events.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients hospitalized because of complicated intra-abdominal infections (cIAI) or complicated skin and soft tissue infections (cSSTI), in the usual health care setting
Condition
  • Intra-Abdominal Infections
  • Skin Disease, Infectious
  • Soft Tissues Infections
InterventionDrug: Tigecycline
Tigecycline 50 or 100 mg intravenously. Therapy conducted according to the package leaflet of Tygacil and to international treatment guidelines. 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
Study Groups/Cohorts1
Patients hospitalized because of cIAI or cSSTI
Intervention: Drug: Tigecycline
Publications *


*   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: November 11, 2011)
115
Original Estimated Enrollment
 (submitted: January 21, 2009)
500
Actual Study Completion DateDecember 2010
Actual Primary Completion DateDecember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Informed consent signed by patients prior to this study entry.
  • 18 years of age or older at the screening visit.
  • Patients with cIAI or cSSTI.
  • Patients who are going to or have just been given in the previous 48 hours at least a dose of tigecycline to treat any of the above infections.
  • In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol.

Exclusion Criteria:

  • Known hypersensibility to tigecycline.
  • Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
  • Use any investigational drug within four weeks of the screening visit.
  • Uncooperative patients or a history of poor compliance.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location CountriesSpain
 
Administrative Information
NCT NumberNCT00827541
Other Study ID NumbersB1811048
3074A1-4401
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2011

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

1-800-718-1021

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[email protected]

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