Journal Article

Safety and Efficacy of Intravenous Tigecycline in Subjects with Secondary Bacteremia: Pooled Results from 8 Phase III Clinical Trials

David Gardiner, Gary Dukart, Angel Cooper and Timothy Babinchak

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 50, issue 2, pages 229-238
Published in print January 2010 | ISSN: 1058-4838
Published online January 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/648720
Safety and Efficacy of Intravenous Tigecycline in Subjects with Secondary Bacteremia: Pooled Results from 8 Phase III Clinical Trials

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  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

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Background

Tigecycline is effective in the treatment of complicated skin/skin-structure infection (cSSSI), complicated intraabdominal infection (cIAI), and community-acquired bacterial pneumonia (CAP), but its efficacy in subjects with secondary bacteremia is unknown.

Methods

Pooled data from subjects enrolled for treatment of cSSSI, cIAI, or CAP presenting with bacteremia from 7 double-blind and 1 open-label trial of tigecycline compared with vancomycin-aztreonam, imipenemcilastatin, levofloxacin, vancomycin, or linezolid were analyzed. The primary efficacy end point was the clinical cure rate at the test-of-cure assessment.

Results

A total of 170 subjects were identified (91 tigecycline recipients and 79 recipients of the comparator agent). Clinical cure rates were 81.3% and 78.5% for tigecycline and the comparator, respectively (P = .702). Analysis by sex, age, creatinine clearance, infection site, Acute Physiology and Chronic Health Evaluation score, and Fine score demonstrated no significant between-group differences. Clinical cure rates for the most commonly represented pathogens (Staphylococcus aureus, Streptococcus pneumoniae, and gram-negative species) were also not significantly different between treatment groups. No decrease in the rate of cure was found in organisms with increasing tigecycline minimum inhibitory concentrations. Nine subjects treated with tigecycline and 1 subject treated with comparator were found to have persistent bacteremia. No clinically significant differences in safety parameters were identified.

Conclusions

Tigecycline was generally safe and well tolerated in the treatment of secondary bacteremia associated with cSSSI, cIAI, and CAP; cure rates were similar to comparative standard therapies.

Journal Article.  6634 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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