Vancomycin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Vancomycin appears in the FDA drug-label database. Marketed as Vancomycin.
- Drug class
- Glycopeptide Antibacterial (FDA established pharmacologic class)
- Boxed warning
- The FDA label for Vancomycin carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.6 ) 1.1 Septicemia Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of septicemia due to: Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.2 Infective Endocarditis Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of infective endocarditis…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Discoloration: Product complaints of discoloration after reconstitution of vials. — AuroMedics Pharma LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-11-25 |
| Presence of Particulate Matter: glass particulate found in vial — Pfizer Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2017-08-30 |
| Presence of Particulate Matter: Glass particulate matter detected in injectable. — Pfizer Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2022-12-22 |
| Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product. — Hospira Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2014-11-07 |
| Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. — Hospira Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2014-10-06 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Chronic Heart Failure | 1 |
| Early Stage Non-Small Cell Lung Cancer | 1 |
| Heart failure | 1 |
| Lung cancer | 1 |
| Multiple Sclerosis | 1 |
Recruiting trials involving Vancomycin
- Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
- Safety Trial of Antimicrobial Therapy and Precision Radiation Therapy in Patients With Oligoprogressive Non-small Cell Lung Cancer
- Vancomycin Study in Multiple Sclerosis (MS)
Common questions
Is Vancomycin FDA-approved?
Yes, marketed as Vancomycin. Its FDA label carries a boxed warning.
How many recruiting trials involve Vancomycin?
3 recruiting trials across 5 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.