Status:
COMPLETED
Post-Authorization Study Evaluating Safety Of Tigecycline
Lead Sponsor:
Pfizer
Conditions:
Intra-Abdominal Infections
Skin Disease, Infectious
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
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 predefi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00827541
Start Date
August 1 2008
End Date
December 1 2010
Last Update
February 1 2012
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