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Diagn Microbiol Infect Dis. 2008 Jul;61(3):329-38. doi: 10.1016/j.diagmicrobio.2008.04.009. Epub 2008 May 27.

Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia.

Collaborators (136)

Abernethy J, Adhikari P, Lynn C, Anderson V, Andrews CP, Antolik J, Areyuna RG, Babjoniseva A, Bauer T, Beechler CR, Bibi S, Bisits M, Bochan MR, Bokarev I, Calistru PI, Campos MI, Chan KM, Chavez ER, Chernyak V, Chuang YC, Clark RV, Counselman FL, Cowan LI, Danielsson PE, Valery MI, de Barros JA, Freire AT, de Mattos WL, Driver AG, Embil J, Engelbrecht JM, Ewig S, Faulk LC, Ferrer VF, Feschenko Y, File TM Jr, French AR, Friedman B, Fritscher CC, Georgiev O, Gerrish CC, Gezon JA, Giordano PA, Graham DR, Green JA, Griffith D, Grimard D, Grossman CH, Gudiol F, Guillermo L, Gupta AK, Harnicarova A, Hayes LE, Heard K, Ionescu V, Iraqui G, Jacobs F, Jakob EJ, Janaskova T, Jurgens J, Kamenik L, Kazlauskas H, Kearl RA, Kelly JJ, Klenha K, Kozlov R, Kumar P, Kus J, Lampron N, Leal IL, Levine D, Liebhart J, Lode H, Lorch DG Jr, Lukacs J, Many WJ, Marinov R, Mazal J, McIvor A, Meriste S, Metev H, Molnar S, Montalvan NR, Moran GJ, Moreira MA, Milutinovic S, Murthy BR, Nonikov V, O'Riordan WD, Otero Mdel R, Paris CA, Paulovic D, Pedersen C, Penn RL, Perez NP, Popov D, Pyttsep E, Rabie WJ, Ramage AS, Ramirez J, Ramos CR, Rapa V, Rebedea I, Regulski M, Reinhardt JF, Reiterer P, Reyes MP, Rohlf J, Roubec J, Rugina S, Sanina N, Ruiz-Palacios y Santos GM, Schrock CG, Simon SJ, Sioson PB, Skerk V, Snyman H, Standiford HC, Starling CE, Stirbulov R, Strausz J, Souza GD, Tanasescu C, Tello AM, Thompson AB 3rd, Tokmalaev A, Tsoi A, Urbina FC, Van Dyk C, Vasquez PE, Villatoro CR, Vrooman PS Jr, Weiss K, Yashyna L, Zaidi SW, Zolubas M.

Author information

1
Department of Internal Medicine, St. Pantelimon Clinical Emergency Hospital, Bucharest OP 22, Romania. cristina.tanaseanu@gmail.com

Abstract

Tigecycline (TGC), a glycylcycline, has expanded activity against Gram-positive and Gram-negative, anaerobic, and atypical bacteria. Two phase 3 studies were conducted. Hospitalized patients with community-acquired pneumonia (CAP) were randomized to intravenous (IV) TGC (100 mg followed by 50 mg bid) or IV levofloxacin (LEV) (500 mg bid). In 1 study, patients could be switched to oral LEV after at least 3 days intravenously. The coprimary efficacy end points were as follows: clinical response in clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure (TOC). The secondary end points were as follows: microbiologic efficacy and susceptibility to TGC for CAP bacteria. Safety evaluations were included. Eight hundred ninety-one were patients screened: 846 mITT (TGC 424, LEV 422), 574 CE (TGC 282, LEV 292). Most patients had Fine Pneumonia Severity Index II to IV (80.7% TGC, 74.4% LEV, mITT). At TOC (CE), TGC cured 253/282 patients (89.7%) and LEV cured 252/292 patients (86.3%); the absolute difference of TGC-LEV was 3.4% (95% confidence interval [CI], -2.2 to 9.1, noninferior [P < 0.001]). In c-mITT, TGC cured 319/394 patients (81.0%) and LEV cured 321/403 patients (79.7%); the absolute difference of TGC-LEV was 1.3% (95% CI -4.5 to 7.1, noninferior [P < 0.001]). The drug-related adverse events (AEs) of nausea (20.8% TGC versus 6.6% LEV) and vomiting (13.2% TGC versus 3.3% LEV) were significantly higher in TGC; elevated alanine aminotransferase (2.8% TGC versus 7.3% LEV) and aspartate aminotransferase (2.6% TGC versus 6.9% LEV) were significantly higher in LEV. Discontinuations for AEs were low (TGC, 26 patients [6.1%]; LEV, 34 patients [8.1%]). TGC appeared safe and achieved cure rates similar to LEV in hospitalized patients with CAP.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00079885 NCT00081575.

[Indexed for MEDLINE]

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