Post-Authorization Study Evaluating Safety Of Tigecycline

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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 usual hospital setting and patients' conditions, in order to assess the "real incidence" of adverse events related with tigecycline in these patients.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Minocycline; Tigecycline

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.