Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT04646135
Eligibility Criteria:
Inclusion Criteria:
* Informed written consent of the 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 who need to undergo mechanical ventilation and hospitalized in PICU;
Exclusion Criteria:
* Hospitalization in PICU expected to be less than 48 hours long;
* Altered renal function (eGFR according to Schwartz \< 30 mL/min/1.73 m2 or creatininemia \> 2 vn);
* Altered liver function (bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 2 NU);
* Altered cardiac function (Ejection Fraction \< 50%);
* Need for administration of neuromuscular blocking drugs;
* Concomitant therapy with continuous infusion drugs containing PG;
* Metronidazole therapy in the three months prior to enrollment;
* History of exposure to LZ in the seven days prior to enrollment;
* Participation in other experimental clinical trials;
* Patient undergoing extracorporeal circulation (dialysis, ECMO)
* Known allergic reaction to LZ or its excipients;
* Weight \< 9 kg;
* Known immaturity of the enzymatic system of alcohol dehydrogenase;
* Pregnancy in progress;
* Ingestion of antifreeze;
* Treatment with silver sulfadiazine for wound care;
* Oncological pathology diagnosed or suspected;
* Valproic acid therapy
* Patients undergoing continuous infusion therapy with drugs used for sedation prior to admission to the red area (excluding dexmedetomidine).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
11 Years
Study:
NCT04646135
Study Brief:
Protocol Section:
NCT04646135