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Post-Authorization Study Evaluating Safety Of Tigecycline

Last updated on December 6, 2018

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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Post-Authorization Study Evaluating Safety Of Tigecycline
A 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
This 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.
Since 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients hospitalized because of complicated intra-abdominal infections (cIAI) or complicated skin and soft tissue infections (cSSTI), in the usual health care setting
  • Intra-Abdominal Infections
  • Skin Disease, Infectious
  • Soft Tissues Infections
Drug: 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
1
Patients hospitalized because of cIAI or cSSTI
Intervention: Drug: Tigecycline


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Spain
 
NCT00827541
B1811048
3074A1-4401
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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