Safety and Efficacy of Ceftazidime-Avibactam Plus Metronidazole in the Treatment of Children >= 3 Months to < 18 Years With Complicated Intra-Abdominal Infection: Results From a Phase 2, Randomized, Controlled Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F19%3AN0000044" target="_blank" >RIV/00064190:_____/19:N0000044 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1097/INF.0000000000002392" target="_blank" >http://dx.doi.org/10.1097/INF.0000000000002392</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1097/INF.0000000000002392" target="_blank" >10.1097/INF.0000000000002392</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Safety and Efficacy of Ceftazidime-Avibactam Plus Metronidazole in the Treatment of Children >= 3 Months to < 18 Years With Complicated Intra-Abdominal Infection: Results From a Phase 2, Randomized, Controlled Trial

Popis výsledku v původním jazyce

Background: Ceftazidime-avibactam plus metronidazole is effective in the treatment of complicated intra-abdominal infection (cIAI) in adults. This single-blind, randomized, multicenter, phase 2 study (NCT02475733) evaluated the safety, efficacy and pharmacokinetics of ceftazidime-avibactam plus metronidazole in children with cIAI. Methods: Hospitalized children (>= 3 months to <18 years) with cIAI were randomized 3: 1 to receive intravenous ceftazidime-avibactam plus metronidazole, or meropenem, for a minimum of 72 hours (9 doses), with optional switch to oral therapy thereafter for a total treatment duration of 7-15 days. Safety and tolerability were assessed throughout the study, along with clinical and microbiologic outcomes, and pharmacokinetics. A blinded observer determined adverse event (AE) causality, and clinical outcomes up to the late follow-up visit. Results: Eighty-three children were randomized and received study drug (61 ceftazidime-avibactam plus metronidazole and 22 meropenem); most (90.4%) had a diagnosis of appendicitis. Predominant Gram-negative baseline pathogens were Escherichia coli (79.7%) and Pseudomonas aeruginosa (33.3%); 2 E. coli isolates were ceftazidime-non-susceptible. AEs occurred in 52.5% and 59.1% of patients in the ceftazidime-avibactam plus metronidazole and meropenem groups, respectively. Serious AEs occurred in 8.2% and 4.5% of patients, respectively; none was considered drug related. No deaths occurred. Favorable clinical/microbiologic responses were observed in >= 90% of patients in both treatment groups at end-of-intravenous treatment and test-of-cure visits. Conclusions: Ceftazidime-avibactam plus metronidazole was well tolerated, with a safety profile similar to ceftazidime alone, and appeared effective in pediatric patients with cIAI due to Gram-negative pathogens, including ceftazidime-non-susceptible strains.

Název v anglickém jazyce

Safety and Efficacy of Ceftazidime-Avibactam Plus Metronidazole in the Treatment of Children >= 3 Months to < 18 Years With Complicated Intra-Abdominal Infection: Results From a Phase 2, Randomized, Controlled Trial

Popis výsledku anglicky

Background: Ceftazidime-avibactam plus metronidazole is effective in the treatment of complicated intra-abdominal infection (cIAI) in adults. This single-blind, randomized, multicenter, phase 2 study (NCT02475733) evaluated the safety, efficacy and pharmacokinetics of ceftazidime-avibactam plus metronidazole in children with cIAI. Methods: Hospitalized children (>= 3 months to <18 years) with cIAI were randomized 3: 1 to receive intravenous ceftazidime-avibactam plus metronidazole, or meropenem, for a minimum of 72 hours (9 doses), with optional switch to oral therapy thereafter for a total treatment duration of 7-15 days. Safety and tolerability were assessed throughout the study, along with clinical and microbiologic outcomes, and pharmacokinetics. A blinded observer determined adverse event (AE) causality, and clinical outcomes up to the late follow-up visit. Results: Eighty-three children were randomized and received study drug (61 ceftazidime-avibactam plus metronidazole and 22 meropenem); most (90.4%) had a diagnosis of appendicitis. Predominant Gram-negative baseline pathogens were Escherichia coli (79.7%) and Pseudomonas aeruginosa (33.3%); 2 E. coli isolates were ceftazidime-non-susceptible. AEs occurred in 52.5% and 59.1% of patients in the ceftazidime-avibactam plus metronidazole and meropenem groups, respectively. Serious AEs occurred in 8.2% and 4.5% of patients, respectively; none was considered drug related. No deaths occurred. Favorable clinical/microbiologic responses were observed in >= 90% of patients in both treatment groups at end-of-intravenous treatment and test-of-cure visits. Conclusions: Ceftazidime-avibactam plus metronidazole was well tolerated, with a safety profile similar to ceftazidime alone, and appeared effective in pediatric patients with cIAI due to Gram-negative pathogens, including ceftazidime-non-susceptible strains.

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

2019

Kód důvěrnosti údajů

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

Název periodika

PEDIATRIC INFECTIOUS DISEASE JOURNAL

ISSN

0891-3668

e-ISSN

1532-0987

Svazek periodika

38

Číslo periodika v rámci svazku

8

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

816-824

Kód UT WoS článku

000480716200023

EID výsledku v databázi Scopus

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