Vancomycin

Generic Name: Vancomycin

Brand Names: Firvanq, Vancocin

Drug Type: Small Molecule

Chemical Formula: C_₆₆H_₇₅Cl_₂N_₉O_₂₄

CAS Number: 1404-90-6

Unique Ingredient Identifier: 6Q205EH1VU

Background: Antibacterial obtained from Streptomyces orientalis. It is a glycopeptide related to ristocetin that inhibits bacterial cell wall assembly and is toxic to kidneys and the inner ear.

As of January 29 2018, CutisPharma's Firvanq is the only FDA approved vancomycin oral liquid treatment option available for the the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains [LP1196]. Such an oral liquid formulation is expected to make Clostridium difficile associated diarrhea therapy more accessible in comparison to previously available specialty compounding products [LP1196].

Indication: Administered intravenously, vancomycin is indicated in adult and pediatric patients for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections. Administered orally, vancomycin is indicated in adult and pediatric patients for the treatment of Clostridium difficile-associated diarrhea and for enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).

Associated Conditions: Clostridium Difficile Associated Diarrhea (CDAD), Enterocolitis caused by Staphylococcus aureus, Infection caused by staphylococci, Severe Staphylococcal infection

Associated Therapies: -

Clinical Trials

Screening to Prophylax Against Clostridium Difficile Infection -

Phase 4

Completed

Conditions: Clostridium Difficile Infection

Interventions: Other: Placebo
Drug: Vancomycin

First Posted Date: 2016-12-19

Last Posted Date: 2024-08-13

Lead Sponsor: William Beaumont Hospitals

Target Recruit Count: 1294

Registration Number: NCT02996487

Locations: 🇺🇸
William Beaumont Hospital, Troy, Michigan, United States

Drug Delivery Devices for Osteomyelitis

Completed

Conditions: Osteomyelitis

Interventions: Device: antibiotic-loaded calcium sulfate
Device: antibiotic-loaded polymethyl methacrylate
Drug: Vancomycin

First Posted Date: 2016-11-18

Last Posted Date: 2018-11-27

Lead Sponsor: Yulin Orthopedics Hospital of Chinese and Western Medicine

Target Recruit Count: 51

Registration Number: NCT02968693

Locations: 🇨🇳
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
🇨🇳
Yulin Orthopedics Hospital of Chinese and Western Medicine, Yulin, Guangxi, China

Cystatin-C C-guided Vancomycin Dosing in Critically Ill Patients: A Quality Improvement Project

Phase 1

Completed

Conditions: Methicillin-resistant Staphylococcus Aureus
Critical Illness
Sepsis

Interventions: Drug: Vancomycin
Other: Cystatin C dosing algorithm
Other: Creatine clearance dosing algorithm

First Posted Date: 2016-10-26

Last Posted Date: 2023-10-10

Lead Sponsor: Mayo Clinic

Target Recruit Count: 399

Registration Number: NCT02945241

MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI)

Phase 1

Completed

Conditions: Clostridium Difficile Infection

Interventions: Drug: MET-2
Drug: Vancomycin

First Posted Date: 2016-08-12

Last Posted Date: 2020-08-11

Lead Sponsor: NuBiyota

Target Recruit Count: 19

Registration Number: NCT02865616

Locations: 🇨🇦
University of Alberta, Edmonton, Alberta, Canada

Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

Phase 2

Completed

Conditions: Clostridium Difficile

Interventions: Drug: Vancomycin
Biological: Cultured human intestinal microbiota
Drug: Metronidazole

First Posted Date: 2016-08-05

Last Posted Date: 2019-01-09

Lead Sponsor: Per Hellström

Target Recruit Count: 60

Registration Number: NCT02857582

Locations: 🇸🇪
Gävle Hospital, Gävle, Gävleborg, Sweden

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

Phase 3

Completed

Conditions: Bacterial Infections
Methicillin-Resistant Staphylococcus Aureus
Staphylococcal Skin Infections

Interventions: Drug: Dalbavancin
Drug: Vancomycin
Drug: Oxacillin
Drug: Flucloxacillin
Drug: Cefadroxil
Drug: Clindamycin

First Posted Date: 2016-06-28

Last Posted Date: 2024-01-17

Lead Sponsor: AbbVie

Target Recruit Count: 199

Registration Number: NCT02814916

Locations: 🇱🇹
Klaipeda Children's Hospital /ID# 235652, Klaipeda, Lithuania
🇧🇬
University Multiprofile Hospital for Active Treatment Deva Maria EOOD Burgas /ID# 235965, Bulgas, Bulgaria
🇧🇬
MHAT (Multiprofile Hospital for Active Treatment) /ID# 235539, Kozloduy, Bulgaria

and more 81 locations

Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

Phase 3

Withdrawn

Conditions: Clostridium Difficile

Interventions: Drug: Vancomycin
Biological: Fecal Microbiota Transplantation
Biological: Fecal Microbiota Transplantation Placebo
Drug: Vancomycin Placebo

First Posted Date: 2016-06-16

Last Posted Date: 2022-04-29

Lead Sponsor: Memorial University of Newfoundland

Registration Number: NCT02801656

Locations: 🇨🇦
Health Sciences Centre, St. John's, Newfoundland and Labrador, Canada

Neonatal Vancomycin Trial

Phase 2

Terminated

Conditions: Late Onset Neonatal Sepsis

Interventions: Drug: Vancomycin

First Posted Date: 2016-06-06

Last Posted Date: 2020-09-09

Lead Sponsor: PENTA Foundation

Target Recruit Count: 242

Registration Number: NCT02790996

Locations: 🇬🇷
Aghia Sophia Children's Hospital (A), Athens, Greece
🇮🇹
Policlinico San Matteo, Pavia, Italy
🇪🇸
Hospital Sant Joan de Deu, Barcelona, Spain

and more 15 locations