Double-Blind, Placebo-Controlled Study of Bezlotoxumab in Children Receiving Antibacterial Treatment for Clostridioides difficile Infection (MODIFY III)

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F23%3A00078215" target="_blank" >RIV/65269705:_____/23:00078215 - isvavai.cz</a>

Result on the web

<a href="https://academic.oup.com/jpids/article/12/6/334/7213927" target="_blank" >https://academic.oup.com/jpids/article/12/6/334/7213927</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/jpids/piad031" target="_blank" >10.1093/jpids/piad031</a>

Result language

angličtina

Original language name

Double-Blind, Placebo-Controlled Study of Bezlotoxumab in Children Receiving Antibacterial Treatment for Clostridioides difficile Infection (MODIFY III)

Original language description

Background. Therapies to prevent recurrence of Clostridioides difficile infection (CDI) in pediatric patients are needed. Bezlotoxumab is a fully human monoclonal antibody approved for prevention of recurrent CDI in adults. We assessed the pharmacokinetics, safety, tolerability, and efficacy of bezlotoxumab in pediatric patients. Methods. MODIFY III was a multicenter, double-blind, placebo-controlled study of bezlotoxumab in children (1 to &lt;18 years) receiving antibacterial treatment for CDI. Participants were randomized 3:1 to receive a single infusion of bezlotoxumab (10 mg/kg) or placebo and were stratified by age at randomization (cohort 1: 12 to &lt;18 years, cohort 2: 1 to &lt;12 years). The primary objective was to characterize bezlotoxumab pharmacokinetics to support dose selection for pediatric patients; the primary endpoint was the area under the bezlotoxumab serum concentration-time curve (AUC(0-inf)). Safety, tolerability, and efficacy were monitored for 12 weeks post-infusion. Results. A total of 148 participants were randomized and 143 were treated: 107 with bezlotoxumab and 36 with placebo (cohort 1 n = 60, cohort 2 n = 83; median age 9.0 years); 52.4% of participants were male and 80.4% were white. Geometric mean ratios (90% CI) for bezlotoxumab AUC(0-inf) were 1.06 (0.95, 1.18) and 0.82 (0.75, 0.89) h * mu g/mL for cohorts 1 and 2, respectively. Bezlotoxumab 10 mg/kg was generally well-tolerated with an adverse event profile similar to placebo, including no treatment discontinuations due to adverse events. CDI recurrence was low and comparable for bezlotoxumab (11.2%) and placebo (14.7%). Conclusions. The results of this study support the bezlotoxumab dose of 10 mg/kg for pediatric patients.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30209 - Paediatrics

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2023

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of the Pediatric Infectious Diseases Society

ISSN

2048-7193

e-ISSN

2048-7207

Volume of the periodical

12

Issue of the periodical within the volume

6

Country of publishing house

US - UNITED STATES

Number of pages

8

Pages from-to

334-341

UT code for WoS article

001021707800003

EID of the result in the Scopus database

2-s2.0-85164424286