Table of Contents
- Clinical trials overview
- Conditions and patient groups
- Trial phases and study designs
- What is being measured
- Selected trials with Vancomycin
- What the trial results mean for patients
Clinical trials overview
These studies investigate Vancomycin in many different research settings, mostly for infections and infection prevention.[1][2] The trials ask questions about whether Vancomycin works, how safe it is in the study setting, and how it compares with other treatments or placebo.[3][4]
Some studies use Vancomycin alone, while others use it together with other antibiotics or as part of a larger treatment strategy.[5][6] A few trials also study Vancomycin in prevention settings, such as before surgery or during transplantation care.[7][8]
Conditions and patient groups
The trial data include people with Staphylococcus aureus bacteremia, which means bacteria are present in the blood.[1] Other studies involve periprosthetic joint infection, pyogenic vertebral osteomyelitis (bone infection in the spine), pleural infections, and infections linked to surgery or implanted material.[5][3][9]
Vancomycin is also studied in people with Clostridioides difficile infection, primary sclerosing cholangitis, active ulcerative colitis, and patients with resistant bacteria such as VRE and MDR Enterobacteriaceae.[7][10][11] The target groups include adults, children, critically ill patients, surgical patients, and patients hospitalized for stem cell transplantation.[2][12]
Trial phases and study designs
The studies cover Phase 1, Phase 2, Phase 3, and one low-intervention trial.[13] Phase 1 studies in the source data focus on drug levels in cerebrospinal fluid or early safety and feasibility in children.[13][14]
Phase 2 trials look at early effectiveness, safety, and biological effects, such as recurrence of infection, drug response, or changes in the gut microbiome.[6][10] Phase 3 trials are larger and often compare Vancomycin with standard care, placebo, or another treatment to test whether one approach is non-inferior, meaning not worse than the other by a set margin.[5][8]
What is being measured
The main outcomes include clinical cure, recurrence, treatment failure, and mortality.[1][3] Some trials also measure whether patients need more antibiotics, surgery, or hospital readmission after the first treatment period.[7][4]
Several studies measure drug levels in blood or cerebrospinal fluid, which helps researchers understand exposure to the treatment in the body.[13][2] Other endpoints include quality of life, health costs, microbiome changes, and laboratory measures such as ALP, which is alkaline phosphatase, a liver-related blood test used in one study.[15][10]
Selected trials with Vancomycin
NCT05137119 is a large Phase 3 platform trial in patients with Staphylococcus aureus bacteremia. It measures all-cause mortality at 90 days and includes Vancomycin among several treatment options.[1]
2023-507617-96-01 studies pyogenic vertebral osteomyelitis and asks whether early switch to oral antibiotics after one week of IV treatment is non-inferior to longer IV treatment. Vancomycin is one of the IV options in the study.[5]
NCT05256693 tests oral Vancomycin to prevent Clostridioides difficile infection in people hospitalized for allogeneic hematopoietic stem cell transplantation, with infection during hospitalization as the main outcome.[7]
NCT05876182 compares oral Vancomycin with placebo in adults and young patients with Primary Sclerosing Cholangitis, using ALP levels at 6 months as the main endpoint.[10]
NCT04731025 studies local antibiotics, including Vancomycin, in women having implant-based breast reconstruction, with implant loss within 180 days as the main outcome.[9]
2024-515791-12-00 is a completed Phase 1 study in children with external ventricular drain that measured Vancomycin levels in cerebrospinal fluid, including Cmax, tmax, AUC0-τ, and half-life.[13]
What the trial results mean for patients
When a trial measures non-inferiority, it is testing whether a shorter or simpler treatment is not meaningfully worse than the standard approach.[5] This matters in studies of infections where shorter treatment could reduce time in hospital or reduce treatment burden if the results are good enough.[8]
When a study looks at microbiome changes, it is studying how treatment may affect the normal germs in the gut.[11] When it measures quality of life or QALYs, it is trying to understand how treatment affects daily life and overall health value, not only infection control.[15]
Overall, the trial program shows that Vancomycin is being studied across many different patient groups, from children to adults, and across both treatment and prevention settings.[1][2] The main focus is whether it helps control infection, prevent recurrence, and do so with acceptable safety and practical benefit.[3][1]
