Monocentric, indipendent, phase II clinical trial, randomized in open to three different lZ delivery sequences in pediatric patients aged 1 and 12, in intensive care and mechanically ventilated. - LZ in paediatric intensive care

IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA0 个研究点目标入组 9 人开始时间: 2021年1月21日最近更新: 2021年4月5日

试验速览

暂无简介。

•Written informed consent of parents or legal representatives of minors according to national law;
•Male and / or female subjects of the following ages: =1 year - <12 years;
•Critical patients subjected to mechanical ventilation and hospitalized in PICU;
•Patients naïve due to drugs for the analgosedation during ongoing hospitalization.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Hospitalization in PICU less than 48 hours;
•Impaired renal function (estimated GFR according to Schwartz <30 mL / min / 1.73 m2 or creatininemia> 2 vn);
•Altered hepatic function (bilirubin, AST, ALT> 2 UN);
•Altered cardiac function (FE <50%);
•Need for administration of neuromuscular blocking drugs;
•Concomitant therapy with drugs in continuous infusion that contain PG (see table 2)
•Metronidazole therapy in the three months prior to entering the study.
•History of exposure to LZ in the seven days prior to enrollment in the study;
•Participation in other experimental clinical studies;
•Patient undergoing extracorporeal circulation (dialysis, ECMO)
•Known allergic reaction to LZ or its excipients;
•Weight <6 kg;
•Known immaturity of the alcohol dehydrogenase enzyme system;
•Pregnancy in progress;
•Ingestion of antifreeze;
•Treatment with silver sulfadiazine for wound care;
•Diagnosed or suspected oncological pathology.
•Valproic acid therapy

发起方

IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA