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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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