N/A
N=115
Post-Authorization Study Evaluating Safety Of Tigecycline
Intra-Abdominal Infections · Skin Disease, Infectious · Soft Tissues Infections
Bottom Line
View on ClinicalTrials.gov: NCT00827541 ↗Enrolled (actual)
115
Serious AEs
27.8%
Results posted
Feb 2012
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 11; 45; 4; 28 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tigecycline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
11; 45; 4; 28 | — |
| SECONDARY Percentage of Participants With Clinical Response of Cure |
10.5; 18.1; 46.2; 42.9; 66.7; 68.8 | — |
| SECONDARY Number of Participants With Susceptible Microbiological Pathogens |
— | — |
| SECONDARY Number of Participants With Eradication of Microbiological Pathogens |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00827541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.