Table of Contents
- Trial overview
- Community-acquired pneumonia study
- Organ preservation and transplant studies
- Serious infection studies
- Children’s heart surgery and transplant studies
- Main endpoints and what they mean
- Trial status and who may participate
Trial overview
The clinical trials listed for Sodium are not all studying the same disease. They cover hospital pneumonia, serious bacterial infections, and organ preservation during transplantation and heart procedures.[1][2][3][4][5][6][7]
Most of the studies are Phase 3 trials, which usually compare treatments in larger groups of patients.[1][3][4][5][6] Two studies are Phase 2 trials, which mainly focus on safety in smaller groups.[2][7]
Community-acquired pneumonia study
One authorised Phase 3 trial, NCT05903352, studies hospitalized patients with community-acquired pneumonia, which means pneumonia caught outside the hospital.[1] The study tests whether stopping antibiotics after the patient becomes stable is not worse than giving antibiotics for the usual fixed duration.[1]
The main outcome is the rate of cure at Day 15 after treatment starts.[1] Cure is defined by stable vital signs, normal mental status, and no extra antibiotic treatment for pneumonia after the first course.[1]
This trial includes 424 patients and compares several antibiotic options used in hospital care, such as pristinamycin, amoxicillin, ceftriaxone, levofloxacin, amoxicillin with a beta-lactamase inhibitor, cefotaxime, and penicillin-related therapy listed in the source data.[1]
Organ preservation and transplant studies
Several trials study organ preservation, which means keeping an organ in good condition before transplantation.[3][4] These studies compare Custodiol-N with Custodiol in liver, kidney, and pancreas transplantation, and they look at whether the new solution is at least as good as the standard one.[3][4]
In the liver transplantation study, NCT2024-518174-13-00, the main endpoint is the area under the curve of GPT (ALT) over the first 7 days after transplantation.[3] GPT, also called ALT, is a blood test used here to track liver injury after the transplant.[3]
In the larger multicenter transplant study, 2024-512444-29-00, the main kidney endpoint is delayed graft function, and the liver endpoint is the area under the curve of GPT (ALT) during the first 7 days after implantation.[4] The study includes patients who will undergo kidney, liver, or kidney-pancreas transplantation, and it has 362 planned participants.[4]
Serious infection studies
One large Phase 3 trial, 2024-514730-21-00, studies critically ill patients with pneumonia, intra-abdominal infection, or bloodstream infection.[5] The trial asks whether a short course of high-dose antimicrobials gives similar results to standard treatment while lowering total antimicrobial exposure.[5]
The main endpoint is all-cause mortality within 90 days after joining the study.[5] This means the study tracks death from any cause, not only death from infection.[5]
Another Phase 3 trial, NCT05117398, studies patients with catheter-related bloodstream infections caused by Staphylococcus aureus, a type of bacteria.[6] It compares a single intravenous dose of dalbavancin with standard antibiotic therapy for 14 days, and the main goal is clinical cure without relapse at Day 30.[6]
The cure definition includes no signs of infection, no return of bacteremia, no deep focus infection such as endocarditis, no extra active antibiotic treatment at the wrong time points, and no death from any cause.[6]
Children’s heart surgery and transplant studies
Two pediatric trials study heart-related procedures in children.[2][7] One Phase 2 study, 2024-511517-38-00, includes children with congenital heart malformation who need cardiac surgery and compares Custodiol-N with Custodiol.[2]
The main goal of that study is safety assessment, measured by continuous reporting of adverse events up to 30 days after surgery.[2] It also measures myocardial protection using CK-MB levels, which are blood test results that can show heart muscle injury.[2]
Another Phase 2 pediatric study, 2023-510492-57-00, looks at organ perfusion in children undergoing heart transplantation.[7] Its primary outcome is safety, measured by adverse event reporting for up to 3 months.[7]
Main endpoints and what they mean
The trials use different primary outcomes, which are the main results the researchers want to measure.[1][2][3][4][5][6][7]
For pneumonia, the endpoint is cure at Day 15, based on stable clinical signs and no extra pneumonia antibiotics.[1]
For liver transplantation, the endpoint is the area under the curve of GPT (ALT) during the first 7 days, which helps show liver injury after surgery.[3]
For kidney and mixed-organ transplantation, the endpoint includes delayed graft function and liver injury markers.[4]
For serious infections in critically ill patients, the endpoint is death from any cause within 90 days.[5]
For bloodstream infection due to Staphylococcus aureus, the endpoint is clinical cure without relapse at Day 30.[6]
For pediatric heart surgery and transplant studies, the main focus is safety and heart muscle protection.[2][7]
Trial status and who may participate
The trial status is mixed: most studies are authorised, while one pediatric cardiac surgery study is suspended.[1][2][3][4][5][6][7]
People who may be included in these studies are hospitalized adults with pneumonia, critically ill patients with serious infections, transplant patients, and children with congenital heart disease or heart transplantation needs.[1][2][3][4][5][6][7]
Enrollment ranges from small pediatric studies with 15 participants to larger multicenter studies with more than 1,000 participants, showing that the research is being done in both focused and broad patient groups.[2][5]
