CLINICAL TRIALS PROFILE FOR VANCOMYCIN

505(b)(2) Clinical Trials for Vancomycin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT01162733 ↗	Loading Vancomycin Doses in the Emergency Department	Completed	Christiana Care Health Services	N/A	2010-07-01	In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.
New Dosage	NCT01734694 ↗	Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients	Terminated	Henry Ford Health System	Phase 4	2011-10-01	For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.
OTC	NCT04674839 ↗	The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals	Completed	Microbio Co Ltd	N/A	2019-10-18	MicrSoy-20 (MS-20), a fermented soymilk product, has been approved as an Over the counter (OTC) drug in 2011. The therapeutic effect of MS-20 is to ameliorate symptoms such as fatigue and loss of appetite caused by cancer chemotherapy. Animal study revealed orally administration of MS-20 daily for 4 weeks altered the gut microbiota composition in mice. In addition, MS-20 could activate dendritic cell and improve immunotherapy response rate. Thus, it was hypothesis that MS-20 improves host immune activity thus ameliorate fatigue and increase weight is through alteration the gut microbiota composition. In this study, the ability of MS-20 in modulating gut microbiota and the subset of microbiome to be altered by MS-20 was investigated.

All Clinical Trials for Vancomycin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003805 ↗	Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1997-11-01	RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.
NCT00034294 ↗	A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea	Completed	Genzyme, a Sanofi Company	Phase 2	2002-02-01	Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.
NCT00035425 ↗	Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection	Completed	Pfizer	Phase 3	2001-11-01	This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
NCT00035854 ↗	New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)	Completed	Pfizer	Phase 3	2002-02-01	This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
NCT00037050 ↗	Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria	Completed	Pfizer	Phase 3	2002-04-01	This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)
NCT00057369 ↗	Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections	Unknown status	Vicuron Pharmaceuticals	Phase 2	2001-02-01	This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.

Clinical Trial Conditions for Vancomycin

Condition Name

Condition Name for Vancomycin
Intervention	Trials
Clostridium Difficile Infection	38
Surgical Site Infection	20
Infection	18
Clostridium Difficile	14

Condition MeSH

Condition MeSH for Vancomycin
Intervention	Trials
Infections	160
Infection	141
Communicable Diseases	128
Clostridium Infections	77

Clinical Trial Locations for Vancomycin

Trials by Country

Trials by Country for Vancomycin
Location	Trials
Canada	94
Spain	42
Brazil	34
United Kingdom	34
Italy	31

Trials by US State

Trials by US State for Vancomycin
Location	Trials
California	62
Texas	61
Ohio	53
Florida	51
New York	49

Clinical Trial Progress for Vancomycin

Clinical Trial Phase

Clinical Trial Phase for Vancomycin
Clinical Trial Phase	Trials
Phase 4	119
Phase 3	89
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for Vancomycin
Clinical Trial Phase	Trials
Completed	191
Recruiting	69
Terminated	48

Clinical Trial Sponsors for Vancomycin

Sponsor Name

Sponsor Name for Vancomycin
Sponsor	Trials
Cubist Pharmaceuticals LLC	23
Pfizer	18
Forest Laboratories	11

Sponsor Type

Sponsor Type for Vancomycin
Sponsor	Trials
Other	538
Industry	171
U.S. Fed	17

Vancomycin: Clinical Trials, Market Analysis, and Projections

Introduction to Vancomycin

Vancomycin is a powerful antibiotic used to treat various bacterial infections, particularly those caused by antibiotic-resistant bacteria such as MRSA (Methicillin-resistant Staphylococcus aureus). Its versatility and effectiveness have made it a crucial component in modern healthcare.

Clinical Trials: Current and Ongoing Studies

PSC-Vanc Study

One notable clinical trial involving vancomycin is the PSC-Vanc Study, led by Dr. Quraishi. This study focuses on patients with Primary Sclerosing Cholangitis (PSC) and Inflammatory Bowel Disease (IBD). The trial aims to understand how vancomycin affects gut bacteria, bile acids, and gene expression in these patients.

• Study Design: The study is an observational, single-arm trial where participants receive 4 weeks of oral vancomycin. Stool samples and colonic biopsies are collected to evaluate changes in gut bacteria and other biochemical markers[1].
• Objectives: The primary goal is to identify specific disease pathways associated with PSC-IBD and potential targets for novel treatments.
• Recruitment: The study has already recruited its participants and is not currently accepting new enrollments.

Vancomycin in Stem Cell Transplant Recipients

Another significant study involves the use of oral vancomycin as a prophylactic measure against Clostridioides difficile (C. diff) infections in stem cell transplant recipients. Conducted by Fox Chase Cancer Center, this research highlights both the benefits and risks of vancomycin prophylaxis.

• Findings: The study showed that oral vancomycin significantly reduces C. diff infection rates but increases the risk of gram-negative bacteremia. This poses a cautionary note for its use in this patient population[4].

Market Analysis

Current Market Size

The global vancomycin market has been growing steadily due to several key factors.

• 2023 Market Size: The market was estimated at USD 693.23 million in 2023[2].
• 2024 Projection: Expected to reach USD 741.53 million in 2024[2].
• Alternative Estimate: Another source estimates the 2023 market size at US$396.7 million[5].

Growth Projections

The vancomycin market is anticipated to continue its growth trajectory over the next few years.

• CAGR: Projected to grow at a Compound Annual Growth Rate (CAGR) of 5.26% to reach USD 992.87 million by 2030[2].
• Alternative Projection: Another estimate suggests a CAGR of 4.9%, reaching US$555.5 million by 2030[5].
• Regional Growth: The U.S. market is expected to rise significantly, while regions like China are forecasted to grow at an impressive 8.2% CAGR[5].

Market Drivers

Several factors are driving the growth of the vancomycin market:

• Antibiotic Resistance: The increasing prevalence of antibiotic-resistant infections, particularly MRSA, has necessitated the use of vancomycin as a last-line treatment option[5].
• Advancements in Manufacturing: Improved production techniques have led to higher yields, enhanced purity, and reduced production costs, making vancomycin more accessible[5].
• Infection Control Awareness: Rising awareness of infection control practices in healthcare settings is also contributing to the market growth[5].

Applications and End-Users

Applications

Vancomycin is used in various clinical applications:

• Sepsis: A significant application segment expected to grow at a CAGR of 5.1% over the analysis period[5].
• Lung Infection: This segment is projected to reach US$201.9 million by 2030 with a CAGR of 6.1%[5].
• Skin and Soft Tissue Infections: Vancomycin is also used to treat these infections, among others[3].

End-Users

The primary end-users of vancomycin include:

• Hospitals: Critical care settings where vancomycin is often used as a last-line treatment for serious infections[5].
• Ambulatory Surgical Centers: These centers also utilize vancomycin for various surgical prophylaxis and treatment needs[2].
• Clinics: General and specialized clinics that treat bacterial infections[2].

Key Players and Competitive Landscape

The vancomycin market is competitive, with several major players involved:

• Alchemia Limited: Known for its pharmaceutical manufacturing capabilities.
• Alvogen: A global pharmaceutical company with a diverse product portfolio.
• Aphios Corporation: Focuses on developing novel pharmaceuticals, including antibiotics.
• Cellceutix Corporation: Engaged in the development of innovative treatments, including those involving vancomycin[5].

Challenges and Considerations

Antibiotic Resistance

The ongoing challenge of antibiotic resistance remains a significant concern. The emergence of multi-drug-resistant bacterial strains necessitates continuous research and development to ensure the efficacy of vancomycin and other antibiotics[5].

Side Effects and Risks

Studies have highlighted potential risks associated with vancomycin use, such as the increased risk of gram-negative bacteremia in certain patient populations. This underscores the need for careful patient selection and monitoring[4].

Key Takeaways

• Clinical Trials: Ongoing studies like the PSC-Vanc Study and the Fox Chase Cancer Center study are crucial for understanding the mechanisms and potential new applications of vancomycin.
• Market Growth: The vancomycin market is projected to grow significantly, driven by factors such as antibiotic resistance, advancements in manufacturing, and increased awareness of infection control.
• Applications: Vancomycin is used in various clinical applications, including sepsis, lung infections, and skin and soft tissue infections.
• End-Users: Hospitals, ambulatory surgical centers, and clinics are the primary end-users of vancomycin.
• Challenges: The market faces challenges such as antibiotic resistance and potential side effects, which necessitate continuous research and careful patient management.

FAQs

What is the current market size of the vancomycin market?

The global vancomycin market was estimated at USD 693.23 million in 2023[2].

What is the projected growth rate of the vancomycin market?

The market is projected to grow at a CAGR of 5.26% to reach USD 992.87 million by 2030[2].

What are the primary applications of vancomycin?

Vancomycin is used to treat sepsis, lung infections, skin and soft tissue infections, and other bacterial infections[3].

What are the risks associated with using vancomycin in stem cell transplant recipients?

Using vancomycin in these patients reduces the risk of C. diff infection but increases the risk of gram-negative bacteremia[4].

Who are the key players in the vancomycin market?

Key players include Alchemia Limited, Alvogen, Aphios Corporation, and Cellceutix Corporation, among others[5].

Sources

1. PSC Support: "PSC-Vanc Study" - https://pscsupport.org.uk/find-psc-research-studies/psc-vanc-study/
2. 360 Research Reports: "Vancomycin Market Size & Share 2025-2030" - https://www.360iresearch.com/library/intelligence/vancomycin
3. Fact.MR: "Vancomycin Market to Expand around 1.5X by 2027" - https://www.biospace.com/vancomycin-market-to-expand-around-1-5x-by-2027-fact-mr-research
4. Fox Chase Cancer Center: "Fox Chase Researchers Find Oral Vancomycin Prevents C. Diff Infection in Stem Cell Transplant Recipients but Raises Risk of Gram-Negative Bacteremia" - https://www.foxchase.org/news/2024-02-19-fox-chase-researchers-find-oral-vancomycin-prevents-c-diff-infection-in-stem-cell-transplant-recipients-but-raises-risk-of-gram-negative-bacteremia
5. GlobeNewswire: "Vancomycin Markets - Global Strategic Business Report Q4, 2024" - https://www.globenewswire.com/news-release/2024/12/18/2998812/0/en/Vancomycin-Markets-Global-Strategic-Business-Report-Q4-2024.html