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Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin.
Diagn Microbiol Infect Dis. 2009 Jan; 63(1):52-61.DM

Abstract

Tigecycline exhibits potent in vitro activity against many community-acquired pneumonia (CAP) pathogens, including antibiotic-resistant ones. Its spectrum of activity and ability to penetrate lung tissue suggest it may be effective for hospitalized CAP patients. Hospitalized CAP patients (n=418) were randomized to receive intravenous (i.v.) tigecycline or levofloxacin. Patients could be switched to oral levofloxacin after receiving 6 or more doses of i.v. study medication. Therapy duration was 7 to 14 days. Coprimary efficacy end points were clinical responses in the clinically evaluable (CE: tigecycline, n=138; levofloxacin, n=156) and clinical modified intent-to-treat (c-mITT: tigecycline, n=191; levofloxacin, n=203) populations at test-of-cure (TOC). Safety was assessed in the mITT population (tigecycline, n=208; levofloxacin, n=210). Cure rates in tigecycline and levofloxacin groups were comparable in CE (90.6% versus 87.2%, respectively) and c-mITT (78% versus 77.8%, respectively) populations at TOC. Nausea and vomiting occurred in significantly more tigecycline-treated patients; elevated alanine aminotransferase and aspartate aminotransferase levels were reported in significantly more levofloxacin-treated patients. There were no significant differences in hospital length of stay, median duration of i.v. or oral antibiotic treatments, hospital readmissions, or number of patients switched to oral levofloxacin. Tigecycline was safe, effective, and noninferior to levofloxacin in hospitalized patients with CAP.

Authors+Show Affiliations

Hospital Cordoba, Córdoba, Provincia de Córdoba, Argentina, 5000. infectologiahcba@yahoo.com.arNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18990531

Citation

Bergallo, Carlos, et al. "Safety and Efficacy of Intravenous Tigecycline in Treatment of Community-acquired Pneumonia: Results From a Double-blind Randomized Phase 3 Comparison Study With Levofloxacin." Diagnostic Microbiology and Infectious Disease, vol. 63, no. 1, 2009, pp. 52-61.
Bergallo C, Jasovich A, Teglia O, et al. Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin. Diagn Microbiol Infect Dis. 2009;63(1):52-61.
Bergallo, C., Jasovich, A., Teglia, O., Oliva, M. E., Lentnek, A., de Wouters, L., Zlocowski, J. C., Dukart, G., Cooper, A., & Mallick, R. (2009). Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin. Diagnostic Microbiology and Infectious Disease, 63(1), 52-61. https://doi.org/10.1016/j.diagmicrobio.2008.09.001
Bergallo C, et al. Safety and Efficacy of Intravenous Tigecycline in Treatment of Community-acquired Pneumonia: Results From a Double-blind Randomized Phase 3 Comparison Study With Levofloxacin. Diagn Microbiol Infect Dis. 2009;63(1):52-61. PubMed PMID: 18990531.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin. AU - Bergallo,Carlos, AU - Jasovich,Abel, AU - Teglia,Osvaldo, AU - Oliva,Maria Eugenia, AU - Lentnek,Arnold, AU - de Wouters,Luisa, AU - Zlocowski,Juan Carlos, AU - Dukart,Gary, AU - Cooper,Angel, AU - Mallick,Rajiv, AU - ,, Y1 - 2008/11/05/ PY - 2008/04/17/received PY - 2008/09/03/revised PY - 2008/09/03/accepted PY - 2008/11/8/entrez PY - 2008/11/8/pubmed PY - 2009/8/7/medline SP - 52 EP - 61 JF - Diagnostic microbiology and infectious disease JO - Diagn Microbiol Infect Dis VL - 63 IS - 1 N2 - Tigecycline exhibits potent in vitro activity against many community-acquired pneumonia (CAP) pathogens, including antibiotic-resistant ones. Its spectrum of activity and ability to penetrate lung tissue suggest it may be effective for hospitalized CAP patients. Hospitalized CAP patients (n=418) were randomized to receive intravenous (i.v.) tigecycline or levofloxacin. Patients could be switched to oral levofloxacin after receiving 6 or more doses of i.v. study medication. Therapy duration was 7 to 14 days. Coprimary efficacy end points were clinical responses in the clinically evaluable (CE: tigecycline, n=138; levofloxacin, n=156) and clinical modified intent-to-treat (c-mITT: tigecycline, n=191; levofloxacin, n=203) populations at test-of-cure (TOC). Safety was assessed in the mITT population (tigecycline, n=208; levofloxacin, n=210). Cure rates in tigecycline and levofloxacin groups were comparable in CE (90.6% versus 87.2%, respectively) and c-mITT (78% versus 77.8%, respectively) populations at TOC. Nausea and vomiting occurred in significantly more tigecycline-treated patients; elevated alanine aminotransferase and aspartate aminotransferase levels were reported in significantly more levofloxacin-treated patients. There were no significant differences in hospital length of stay, median duration of i.v. or oral antibiotic treatments, hospital readmissions, or number of patients switched to oral levofloxacin. Tigecycline was safe, effective, and noninferior to levofloxacin in hospitalized patients with CAP. SN - 1879-0070 UR - https://www.unboundmedicine.com/medline/citation/18990531/Safety_and_efficacy_of_intravenous_tigecycline_in_treatment_of_community_acquired_pneumonia:_results_from_a_double_blind_randomized_phase_3_comparison_study_with_levofloxacin_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0732-8893(08)00400-8 DB - PRIME DP - Unbound Medicine ER -