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.

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.