American Journal of Otolaryngology - Head and Neck Medicine and Surgery
Volume 28, Issue 2 , Pages 78-82, March 2007

Moxifloxacin vs amoxicillin/clavulanate in the treatment of acute sinusitis☆

  • José R. Arrieta, MD

      Affiliations

    • Hospital General “Dr. Manuel Gea González”, Mexico City, Mexico
    • ,
  • Alejandro S. Galgano, MD

      Affiliations

    • Departmento de Otorrinolaringologia, Policlínico Bancario, Buenos Aires, Argentina
    • ,
  • Eulalia Sakano, MD

      Affiliations

    • Clínica e Hospital de Otorrinolaringologia do Instituto Penido Bunier Ltda. Sao Paulo, Brazil
    • ,
  • Ximena Fonseca, MD

      Affiliations

    • Centro de Otorrinolaringología, Universidad Católica de Chile, Santiago, Chile
    • ,
  • Carlos F. Amábile-Cuevas, DSc

      Affiliations

    • Fundación LUSARA, Mexico City, DF, Mexico
    • Corresponding Author InformationCorresponding author. Fundación Lusara, Apartado Postal 102-006, 08930, Mexico City, DF, Mexico. Tel.: +52 55 5219 5855; fax: +52 55 5219 5855.
    • ,
  • Gerardo Hernández-Oliva, MD

      Affiliations

    • Dirección Médica, Bayer de México S.A. de C.V., Mexico City, Mexico
    • ,
  • Raul Vivar, MD

      Affiliations

    • Dirección Médica, Bayer de México S.A. de C.V., Mexico City, Mexico
    • ,
  • Gerardo González, MD

      Affiliations

    • Dirección Médica, Bayer de México S.A. de C.V., Mexico City, Mexico
    • ,
  • Arturo Torres, MD

      Affiliations

    • Dirección Médica, Bayer de México S.A. de C.V., Mexico City, Mexico
    • ,
  • the Moxifloxacin in Acute Sinusitis Study (MASS) Latin American Study Group

      Affiliations

    • The MASS Latin American Study Group. Mexico: G Hernández-Valencia, J Mañé-Ramírez, B Robles-Mariscal, E Obispo, L Hernández-Portilla, JL Vargas-Jiménez, JJ Viveros-Romero, J González-Anguiano, R Espinosa-Ulloa, J Cruz-Ponce, J Treviño-Garza, F Velásquez-Vargas, C Pane-Pianese, R Magallón, JJ Ceja, J Olguín, MR Rivera, J Pérez, Y Hernández, A Hernández. Argentina: C Ranieri, G Martínez-Goya, H Murga, H Murga Jr, G Kaminszczik, P Ontivero, C Borzi, E Goebel. Brazil: C Cidade Gomes, R Guimarães Pereira, A Miniti, L Ubirajara Sennes, R Ferreira Bento, P Santoro, L Weckx, M Scarpin Teixeira, M Mocellin, W Anselmo, S Pancotti, MSC Christo, SAC Salas. Chile: J Abiuso, F Galleguillos, P Sepúlveda, S Sanhueza, C Silva, P Matamala, A Samith, R Flaskamp.

Received 3 March 2006

Authors G H-O, RV (now at Roche), GG (now in private practice), and AT (now at Abbott) were members of the staff of Bayer de México at that time; all other authors state that although they received a grant from Bayer to conduct this study, results were in no way modified in favor of the sponsor's product.

Abstract 

Purpose

The aim of this study was to compare the efficacy and safety of moxifloxacin with that of amoxicillin/clavulanate for the treatment of acute bacterial sinusitis in adults.

Materials and methods

Five hundred seventy-five patients from Latin American countries were randomized to receive oral moxifloxacin 400 mg once daily for 7 days, or oral amoxicillin/clavulanate 500/125 mg 3 times daily for 10 days, in a prospective, open study.

Results

At the test-of-cure visit (7-14 days after the end of therapy), the clinical success rate in the moxifloxacin group was 93.4% similar to that in the amoxicillin/clavulanate group (92.7%). Documented bacteriological eradication plus presumed eradication rates in the moxifloxacin (96.5%) and the amoxicillin/clavulanate (96.7%) groups were also similar. Drug-related adverse events were recorded in 32.2% of patients in the moxifloxacin group and 29.7% in the amoxicillin/clavulanate group. Patient discontinuation in the trial due to adverse events occurred for 10 patients in the moxifloxacin group and 6 in the amoxicillin/clavulanate group.

Conclusions

Overall, in terms of clinical and bacteriological response, moxifloxacin was equivalent to amoxicillin/clavulanate for the treatment of acute bacterial sinusitis in adults.

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☆ This study was supported by Bayer AG (Pharma Research Center and Medical Research Department), Wuppertal, Germany, and Bayer de México, SA de CV, Mexico City, Mexico.

PII: S0196-0709(06)00124-4

doi:10.1016/j.amjoto.2006.06.016

American Journal of Otolaryngology - Head and Neck Medicine and Surgery
Volume 28, Issue 2 , Pages 78-82, March 2007

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