Efficacy of bezlotoxumab based on timing of administration relative to start of antibacterial therapy for Clostridium difficile infection.
J Antimicrob Chemother
; 73(9): 2524-2528, 2018 09 01.
Article
en En
| MEDLINE
| ID: mdl-29788418
ABSTRACT
Background:
The fully human monoclonal antibody bezlotoxumab binds Clostridioides (Clostridium) difficile toxin B and reduces recurrence rates in patients with C. difficile infection (CDI) receiving antibacterial treatment for a primary or recurrent episode.Objectives:
To investigate whether the timing of bezlotoxumab administration relative to the onset of antibacterial treatment affected clinical outcome in the Phase 3 trials MODIFY I (NCT01241552) and MODIFY II (NCT01513239).Methods:
Initial clinical cure and CDI recurrence rates of participants who received bezlotoxumab or placebo were summarized by timing of infusion relative to the start of antibacterial drug treatment for CDI 0-2, 3-4 and ≥5 days after onset.Results:
Of 1554 total participants, 649 (41.8%), 469 (30.1%) and 436 (28.1%) received an infusion 0-2, 3-4 and ≥5 days after onset of antibacterial treatment for CDI, respectively. Regardless of timing of administration, there were no differences in initial clinical cure rates between participants receiving bezlotoxumab (range 77.8% to 81.4%) or placebo (77.8% to 81.7%). Bezlotoxumab efficacy was unaffected by timing of administration; rates of CDI recurrence were lower versus placebo in all subgroups (range 19.3% to 22.8% for bezlotoxumab and 31.7% to 35.8% for placebo). Timing of administration also had no effect on time to resolution of diarrhoea, which was achieved by the end of antibacterial treatment in â¼95% of participants in both bezlotoxumab and placebo groups.Conclusions:
Bezlotoxumab is effective in preventing CDI recurrence and can be administered at any time before ending antibacterial drug treatment.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Antitoxinas
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Infecciones por Clostridium
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Anticuerpos Neutralizantes
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Antibacterianos
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Anticuerpos Monoclonales
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2018
Tipo del documento:
Article