N/A 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

Bottom Line

View on ClinicalTrials.gov: NCT01072539 ↗

Enrolled (actual)

3,172

Serious AEs

13.2%

Results posted

May 2016

Primary outcome: 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 Percentage of 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: Apr 2015

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	—

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.

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

View full record on ClinicalTrials.gov →

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.