Table of Contents

• Trial overview
• Conditions and patient groups
• Trial phases and study designs
• Main endpoints and what they mean
• Selected trial details
• Patient glossary

Trial overview

Clinical trials with Vancomycin Hydrochloride are looking at several different clinical questions, not only one disease area.^[1][2] The studies include prevention of surgical site infection, treatment of Clostridioides difficile infection, use in serious infections, and research in bowel disease and cancer.^[1][2]

The trials are mostly interventional, which means the researchers assign a treatment and then measure the results.^[1][2] The listed studies are in Phase 2 or Phase 3, showing that they are testing treatment effects in patients and comparing options in larger or more focused groups.^[1][2]

Conditions and patient groups

One Phase 3 study is testing surgical antibiotic prophylaxis, which means antibiotic treatment given around surgery to help prevent infection.^[1] This study includes patients having surgery, and it compares linezolid with vancomycin for prevention of surgical site infection.^[1]

Several trials focus on infection-related conditions. These include Staphylococcus aureus bacteremia, staphylococcal endocarditis, serious infections needing intravenous treatment, and Clostridioides difficile infection.^[3][4][6][7] Some of these studies are for adults with severe illness, while others are for children with infection disease or inflammatory bowel disease.^[3][9][10]

There are also studies in ulcerative colitis, including a Phase 2 study in mild-to-moderate disease and a pediatric study that looks at bowel healing and stool markers.^[2][10] In cancer research, Vancomycin Hydrochloride appears in studies of hepatocellular carcinoma, which is a type of liver cancer.^[5][8]

Trial phases and study designs

The trial list includes Phase 2 and Phase 3 studies only.^[1][2] Phase 2 studies in this set include ulcerative colitis, Clostridioides difficile infection, hepatocellular carcinoma, and pediatric inflammatory bowel disease.^{[2][5][7][8][10]}

Phase 3 studies include surgical infection prevention, serious infections with model-informed dosing, staphylococcal endocarditis, pediatric infection treatment by continuous infusion, and diabetic foot osteomyelitis.^{[1][3][4][6][9][11]}

Some studies compare one treatment with another, such as linezolid versus vancomycin, or a shorter versus longer course of oral vancomycin.^[1][7] Other studies compare active treatment with placebo, which is an inactive look-alike treatment used for fair comparison.^[2][8]

Main endpoints and what they mean

A primary outcome is the main result a trial is designed to measure.^[1] In these studies, the main outcomes include surgical site infection rates by day 30, endoscopic response by day 56, and recurrence of Clostridioides difficile infection within 60 days after treatment ends.^[1][2][7]

Some trials look at survival and treatment failure. For example, one study measures 90-day survival without clinical or microbiological failure, and another measures 6-month all-cause mortality after randomization.^[4][6] These outcomes help show whether a treatment keeps patients alive and whether the infection comes back or does not improve.

Other studies focus on safety and biological response. Safety outcomes include treatment-emergent adverse events, serious adverse events, and events rated as severe.^[2][5][8] Cancer and bowel disease studies also measure immune or tissue changes, such as CD8+ T cells in tumor tissue or stool calprotectin, which is a marker of bowel inflammation.^[8][10]

The ProVanc study measures whether patients stay in the therapeutic target range, meaning the planned treatment exposure range, for most of the treatment time.^[3] The pediatric continuous infusion study measures hospital stay, fever duration, readmission, and possible relapse.^[9] The diabetic foot osteomyelitis study measures whether the ulcer or bone infection is healed at 12 and 24 weeks.^[11]

Selected trial details

• LOVip is a Phase 3 study in surgical antibiotic prophylaxis with 1,160 planned participants. It compares linezolid with vancomycin and measures surgical site infection rates at 30 days after surgery.^[1]

• NCT05370885 is a Phase 2 study in mild-to-moderate ulcerative colitis with 172 participants. It measures endoscopic response at day 56 and tracks safety in both blinded and open-label parts.^[2]

• ProVanc is a Phase 3 study in critically ill adults with serious infections needing intravenous vancomycin. It tests a model-informed precision dosing tool and measures how often patients stay in the target exposure range.^[3]

• SAB 7 is a Phase 3 study in uncomplicated Staphylococcus aureus bacteremia with 284 participants. It compares 7 days versus 14 days of antibiotic therapy and measures 90-day survival without treatment failure or relapse.^[4]

• RESCUE-HUB is a Phase 2 study in unresectable hepatocellular carcinoma with 15 participants. It looks at safety and disease control after fecal microbiota transplantation added to first-line therapy, and Vancomycin Hydrochloride is part of the intervention list.^[5]

• RIFREE is a Phase 3 study in staphylococcal prosthetic valve endocarditis with 422 participants. It measures all-cause mortality at 6 months after randomization and includes a vancomycin-containing regimen among the study treatments.^[6]

• ANTROP-I is a Phase 2 study in Clostridioides difficile infection with 244 participants. It compares 5-day treatment with the standard 10-day oral vancomycin course and measures recurrence within 60 days after treatment ends.^[7]

• FLORA is a Phase 2 study in hepatocellular carcinoma with 48 participants. It measures tumor CD8+ T lymphocytes after two cycles of treatment and tracks safety events through day 105.^[8]

• Continuous antibiotic infusion in children is a Phase 3 study with 150 planned participants. It includes Vancosan and measures hospital stay, fever, antibiotic treatment duration, readmission, and relapse.^[9]

• Oral vancomycin therapy in pediatric inflammatory bowel disease is a Phase 2 study with 140 participants. It measures remission and stool inflammation markers, and it compares findings before and after treatment.^[10]

• LIBRETTO is a Phase 3 study in diabetic foot osteomyelitis with 84 participants. It compares local antibiotic delivery with systemic antibiotic therapy and measures healing and resolution at 12 and 24 weeks.^[11]

Patient glossary

Surgical site infection means an infection that happens in the area of the body where surgery was done.^[1]

Bacteremia means bacteria are present in the blood.^[4]

Endocarditis is an infection of the inner lining or valves of the heart.^[6]

Flexible sigmoidoscopy is a test that uses a small camera to look inside the lower bowel.^[2]

Mayo endoscopic subscore is a score used to rate how inflamed the bowel looks during the camera test.^[2]

RECIST 1.1 is a way to measure whether a cancer is shrinking, stable, or growing.^[5]

CD8+ T lymphocytes are immune cells that can be counted in tissue samples to study the immune response.^[8]

Calprotectin is a stool marker that can show bowel inflammation.^[10]

Osteomyelitis means infection of the bone.^[11]

Placebo is a look-alike treatment with no active medicine, used to compare results fairly.^[2][8]