N/A
Completed N=156
French Study In ICU Patients Treated With Tigecycline
Source: ClinicalTrials.gov NCT00799591 ↗Enrolled (actual)
156
Serious AEs
16.7%
Results posted
Dec 2011
Primary outcomePrimary: Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT) — 59.6; 2.6; 15.4; 22.4 percentage of participants
Summary
This study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned. Data will be collected only from subjects providing informed consent.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT) |
59.6; 2.6; 15.4; 22.4 | — |
| PRIMARY Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit |
53.1; 22.1; 24.8 | — |
| SECONDARY Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose |
97.4; 2.6; 93.6; 0.6 | — |
| SECONDARY Mean Duration (Days) of Treatment With Tigecycline |
10.2 | — |
| SECONDARY Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT |
22.6; 14.0; 15.1; 9.7 | — |
| SECONDARY Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit |
23.4; 14.3; 15.6; 10.4 | — |
| SECONDARY Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture |
8.8 | — |
| SECONDARY Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination |
66.7; 27.3; 18.2; 3.0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult men and women (18 years).
- Subjects hospitalized in a medical or surgical intensive care unit (ICU) (on the day of enrolment in the study).
- Subjects treated with tigecycline (first, second or third line), said treatment freely chosen by the participating physician, prior to enrollment in the study.
Exclusion Criteria
- Subjects participating in another biomedical research study.
- Patient (or legal representative) who has not dated or signed informed consent document.
Data sourced from ClinicalTrials.gov (NCT00799591). 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. Informational only — not medical advice.