Table of Contents
- Trial overview
- Patient groups studied
- Study designs and phases
- Main outcomes measured
- Selected trial details
- What these studies mean for patients
Trial overview
The clinical trials listed here study Amikacin Sulfate in serious infection settings, often as part of a broader antibiotic plan or treatment strategy.[1] The trials focus on whether it helps improve outcomes such as survival, infection control, and treatment success in different patient groups.[1]
The conditions studied include sepsis, bloodstream infections, urinary tract infections, pneumonia, acute pyelonephritis, liver abscess, and other severe infections in critically ill patients.[1]
Patient groups studied
These studies include several different patient groups, such as critically ill adults in intensive care, adults with gram-negative bacteraemia, children aged 1 month to 3 years with acute pyelonephritis, and patients with hospital-acquired infections.[1]
Some trials focus on very specific groups, like neutropenic patients with sepsis, where neutropenic means having a low number of neutrophils, a type of white blood cell that helps fight infection.[1] Other trials study patients receiving ECMO, which means extracorporeal membrane oxygenation, a life-support treatment that helps the heart and lungs work.[1]
Study designs and phases
Most of the listed trials are Phase 3 studies, which usually compare treatments in larger groups of patients to see how well they work in real clinical use.[1] Two trials are Phase 2 studies, including a pilot study and a non-inferiority study, which means they test whether one approach works at least as well as another by a set margin.[1]
Several trials are randomized, which means people are assigned to groups by chance, helping make the comparison fair.[1] One study uses a 2 by 2 factorial design, which means it tests two strategies at the same time in different combinations.[1]
Main outcomes measured
The trials measure different outcomes depending on the infection being studied.[1] Common outcomes include day-30 mortality, day-90 mortality, clinical cure, bacterial eradication, recurrence of infection, treatment failure, and antibiotic plasma targets.[1]
Some studies also measure whether patients need more antibiotic treatment, whether symptoms go away, and whether follow-up cultures are negative, which means no bacteria are found in the tested sample.[1]
Selected trial details
NCT05443854 is a Phase 3 trial in critically ill adult patients with sepsis, with an enrollment of 340.[1] It studies a strategy of routine aminoglycoside use in initial antibiotic therapy and looks at day-90 mortality as the main outcome.[1]
NCT05199324 is a Phase 3 study in 730 patients with gram-negative bacteraemia, comparing early step-down to oral treatment with continuing intravenous therapy.[2] Amikacin Sulfate is listed among the intravenous treatments used in the study, and the main outcome is all-cause mortality at day 30.[2]
NCT05117398 is a Phase 3 trial in 406 patients with catheter related bloodstream infections due to Staphylococcus aureus.[3] It measures clinical cure without relapse at day 30, meaning the infection signs are gone, the infection does not return, and there is no death from any cause during the study period.[3]
2023-503447-33-00 is a Phase 2 trial in 560 patients with febrile urinary tract infection.[4] It studies whether oral step-down treatment is non-inferior to standard care, and the main outcome is clinical response at test of cure after treatment ends.[4]
2023-509722-22-00 is a small Phase 2 pilot study with 26 patients receiving ECMO for ventilator-associated gram-negative pneumonia.[5] It tests inhaled Amikacin Sulfate for 5 days and measures bacterial eradication on day 5 using a tracheal aspirate, which is a mucus sample taken from the breathing tube.[5]
NCT05544565 is a Phase 3 study in 480 children aged 1 month to 3 years with acute pyelonephritis.[6] It compares a 3-day intravenous antibiotic course with a 3-day intravenous course followed by 7 days of oral treatment, and the main endpoint is recurrence of febrile urinary tract infection within 28 days after treatment.[6]
2024-516232-10-00 is a large Phase 3 study in 1,250 critically ill patients with serious infections.[7] It measures antibiotic pharmacokinetic/pharmacodynamic plasma targets, which means the study checks whether drug levels in the blood match the planned exposure target.[7]
NCT05681442 is a Phase 3 sepsis trial in 600 ICU patients, and its primary endpoint is 30-day mortality.[8] This study compares different ways of giving the main beta-lactam antibiotic and includes Amikacin Sulfate among the treatment options.[8]
2025-520940-14-00 is a Phase 3 non-inferiority trial in 456 patients with pyogenic liver abscess after drainage.[9] It looks at treatment failure between the end of treatment and week 12 after drainage, and Amikacin Sulfate is one of the listed antibiotic options.[9]
NCT05905055 is a completed Phase 3 study in 150 adults with several serious infections due to carbapenem-resistant Enterobacterales.[10] It measures overall treatment success at test of cure across infection types and also assesses safety.[10]
What these studies mean for patients
These trials show that Amikacin Sulfate is being studied in high-risk infections where fast and effective treatment is very important.[1] The research does not focus on one single disease, but on different infection settings where doctors need better ways to improve outcomes.[1]
For patients and families, the key points are that trial teams are looking at whether the treatment strategy helps people recover, avoids infection coming back, and improves survival.[1] The studies also help define which patient groups may benefit most, including adults in intensive care and young children with kidney infection.[1]
