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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30209 - Paediatrics

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2023

Kód důvěrnosti údajů

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

Název periodika

Journal of the Pediatric Infectious Diseases Society

ISSN

2048-7193

e-ISSN

2048-7207

Svazek periodika

12

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

334-341

Kód UT WoS článku

001021707800003

EID výsledku v databázi Scopus

2-s2.0-85164424286