Ensayo clínico prospectivo, multinacional, multicéntrico, aleatorizado, doble ciego, doble simulación, que compara la eficacia y la seguridad de moxifloxacino respecto a amoxicilina/ácido clavulánico ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-006096-37

Ensayo clínico prospectivo, multinacional, multicéntrico, aleatorizado, doble ciego, doble simulación, que compara la eficacia y la seguridad de moxifloxacino respecto a amoxicilina/ácido clavulánico en el tratamiento de pacientes con exacerbaciones agudas de bronquitis crónica”Estudio MAESTRAL. (A prospective, multinational, multicenter, randomized, double-blind, double-dummy, controlled study comparing the efficacy and safety of moxifloxacin to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbations of chronic bronchitis: MAESTRAL (moxifloxacin in AECB superiority trial)

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Extrait

The primary objective is to compare the efficacy of moxifloxacin 400 mg PO OD for five days with the respective efficacy of amoxicillin clavulanic acid 875/125 mg PO BID for seven days in the treatment of subjects with AECB. The primary efficacy endpoint will be clinical failure rates at 8 weeks post-therapy visit in outpatients with AECB. Clinical failure is defined as the requirement for additional (including increased dose or duration of treatment) systemic antibiotics and/or systemic corticosteroids and/or hospitalization with antibiotic and/or systemic corticosteroid administration within 8 weeks post therapy.


Critère d'inclusion

  • Exacerbaciones agudas de bronquitis crónicas (acute exacerbation of chronic bronchitis)