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Last Updated: June 14, 2024


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vancomycin

Condition Name

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

Condition MeSH for Vancomycin
Intervention Trials
Infections 156
Infection 141
Communicable Diseases 128
Clostridium Infections 76
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Clinical Trial Locations for Vancomycin

Trials by Country

Trials by Country for Vancomycin
Location Trials
Canada 94
Spain 42
Brazil 34
United Kingdom 33
Italy 31
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Vancomycin
Clinical Trial Phase Trials
Phase 4 117
Phase 3 88
Phase 2/Phase 3 14
[disabled in preview] 85
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Clinical Trial Status

Clinical Trial Status for Vancomycin
Clinical Trial Phase Trials
Completed 191
Recruiting 66
Terminated 48
[disabled in preview] 88
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Clinical Trial Sponsors for Vancomycin

Sponsor Name

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

Sponsor Type for Vancomycin
Sponsor Trials
Other 530
Industry 171
U.S. Fed 17
[disabled in preview] 16
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