CompletedNot Applicable

Post-Authorization Study Evaluating Safety Of Tigecycline

115 participantsStarted 2008-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to Week 12

Trial details

NCT IDNCT00827541

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-12

Results submitted2011-12-23

View on ClinicalTrials.gov More Intra-Abdominal Infections trials