N/A
Completed N=3,172
Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
Complicated Skin and Skin Structure Infections · Complicated Intra-abdominal Infections · Community-acquired bacterial pneumonia
Source: ClinicalTrials.gov NCT01072539 ↗
Enrolled (actual)
3,172
Serious AEs
13.2%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs — 32.98; 9.85; 13.22; 0.13 Percentage of Participants
Summary
The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs |
32.98; 9.85; 13.22; 0.13; 8.24; 0.44 | — |
| PRIMARY Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics |
34.15; 32.62; 30.98; 35.55; 30.16; 27.46 | 0.0067 sig |
| SECONDARY Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment |
59.68; 74.97; 71.59 | — |
| SECONDARY Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site |
77.53; 71.52; 45.35; 0.00; 50.00; 71.59 | <0.0001 sig |
| SECONDARY Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) |
46.69; 32.68; 20.62 | — |
Eligibility Criteria
Inclusion Criteria
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
Adults 18 years of age or older, who have one of the followings:
- Complicated skin and skin structure infections
- Complicated intra-abdominal infections
- Community-acquired bacterial pneumonia
Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
- Patients who have known hypersensitivity to tigecycline
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
Data sourced from ClinicalTrials.gov (NCT01072539). 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.