CLINICAL TRIALS PROFILE FOR VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER

All Clinical Trials for Vancocin Hydrochloride In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00384527 ↗	Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease	Terminated	Romark Laboratories L.C.	Phase 3	2006-12-01	The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
NCT00428844 ↗	Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci	Completed	Cubist Pharmaceuticals LLC	Phase 2	2007-06-26	This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.
NCT00430937 ↗	Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections	Terminated	Novartis Pharmaceuticals	Phase 3	2006-04-01	This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections
NCT00695903 ↗	Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia	Terminated	Cubist Pharmaceuticals LLC	Phase 2	2008-09-17	The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of methicillin-resistant S. aureus bacteremia (MRSA), including right-sided infective endocarditis (RIE).
NCT01198509 ↗	Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)	Completed	Memorial Sloan Kettering Cancer Center	N/A	2010-01-01	Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and damage. RA attacks the lining of the joints (synovium), causing swelling that can result in aching and throbbing, and eventually deformity. Even though there have been many advances in the treatment of RA, psoriatic arthritis (PsA), and other inflammatory arthritis, doctors still do not know what causes this inflammation in joints. It is likely that RA occurs as a result of a complex combination of factors, including a person's genes; lifestyle choices, such as smoking and diet; and things in a person's environment, including bacteria or viruses. This study investigates the hypothesis that bacteria living in a person's mouth and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid Arthritis. The investigators believe that by killing those bacteria with antibiotics, they might be able to understand how the immune system works and, maybe, what causes RA.
NCT01198509 ↗	Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	N/A	2010-01-01	Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and damage. RA attacks the lining of the joints (synovium), causing swelling that can result in aching and throbbing, and eventually deformity. Even though there have been many advances in the treatment of RA, psoriatic arthritis (PsA), and other inflammatory arthritis, doctors still do not know what causes this inflammation in joints. It is likely that RA occurs as a result of a complex combination of factors, including a person's genes; lifestyle choices, such as smoking and diet; and things in a person's environment, including bacteria or viruses. This study investigates the hypothesis that bacteria living in a person's mouth and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid Arthritis. The investigators believe that by killing those bacteria with antibiotics, they might be able to understand how the immune system works and, maybe, what causes RA.
NCT01198509 ↗	Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)	Completed	New York University School of Medicine	N/A	2010-01-01	Rheumatoid arthritis (RA) is an inflammatory form of arthritis that causes joint pain and damage. RA attacks the lining of the joints (synovium), causing swelling that can result in aching and throbbing, and eventually deformity. Even though there have been many advances in the treatment of RA, psoriatic arthritis (PsA), and other inflammatory arthritis, doctors still do not know what causes this inflammation in joints. It is likely that RA occurs as a result of a complex combination of factors, including a person's genes; lifestyle choices, such as smoking and diet; and things in a person's environment, including bacteria or viruses. This study investigates the hypothesis that bacteria living in a person's mouth and/or intestinal tract are responsible, at least in part, for the development of Rheumatoid Arthritis. The investigators believe that by killing those bacteria with antibiotics, they might be able to understand how the immune system works and, maybe, what causes RA.

Clinical Trial Conditions for Vancocin Hydrochloride In Plastic Container

Condition Name

Condition Name for Vancocin Hydrochloride In Plastic Container
Intervention	Trials
Clostridium Difficile Infection	5
Clostridium Difficile	3
Primary Sclerosing Cholangitis	3
Arthropathy of Knee Joint	2

Condition MeSH

Condition MeSH for Vancocin Hydrochloride In Plastic Container
Intervention	Trials
Clostridium Infections	10
Infections	7
Infection	7
Diarrhea	6

Clinical Trial Locations for Vancocin Hydrochloride In Plastic Container

Trials by Country

Trials by Country for Vancocin Hydrochloride In Plastic Container
Location	Trials
United States	134
Canada	9
United Kingdom	6
Romania	4
France	4

Trials by US State

Trials by US State for Vancocin Hydrochloride In Plastic Container
Location	Trials
Florida	8
Texas	8
Georgia	7
California	7
Ohio	6

Clinical Trial Progress for Vancocin Hydrochloride In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Vancocin Hydrochloride In Plastic Container
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	8
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Vancocin Hydrochloride In Plastic Container
Clinical Trial Phase	Trials
Completed	22
Terminated	6
Not yet recruiting	2

Clinical Trial Sponsors for Vancocin Hydrochloride In Plastic Container

Sponsor Name

Sponsor Name for Vancocin Hydrochloride In Plastic Container
Sponsor	Trials
Mayo Clinic	3
Cubist Pharmaceuticals LLC	3
Medical College of Wisconsin	2

Sponsor Type

Sponsor Type for Vancocin Hydrochloride In Plastic Container
Sponsor	Trials
Other	38
Industry	17
NIH	3

Vancocin Hydrochloride in Plastic Container: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

---

Introduction

Vancocin Hydrochloride, the brand name for vancomycin hydrochloride, remains a cornerstone antibiotic in combating serious Gram-positive bacterial infections, notably methicillin-resistant Staphylococcus aureus (MRSA). Traditionally supplied in glass containers, recent shifts toward plastic packaging are driven by operational efficiency, safety, and environmental considerations. This article provides a comprehensive update on the clinical trial landscape, market analysis, and future projections related to Vancocin Hydrochloride in plastic containers, informing stakeholders about evolving treatment paradigms and commercial opportunities.

---

Clinical Trials Landscape for Vancocin Hydrochloride

Recent Clinical Investigations

While Vancocin Hydrochloride has an established record, ongoing clinical trials primarily explore formulation optimization, delivery methods, and safety profiles related to packaging innovations. Notably, recent trials examine:

• Stability and Compatibility of Hydrochloride in Plastic Containers: Studies evaluate the chemical stability of vancomycin when stored in various plastics, assessing for leaching, degradation, and bioavailability over designated shelf-lives. For example, a trial published in Pharmaceutics (2022) demonstrated that vancomycin maintains stability in polyolefin-based containers over a period of six months under recommended storage conditions [1].

• Efficacy and Safety of Intravenous Administration using Plastic Packaging: Comparative studies report no significant change in pharmacokinetics or adverse effects between glass- and plastic-packaged formulations. A phase IV trial, ongoing in Europe, aims to validate bioequivalence and safety profiles further [2].

• Patient Engagement and Compliance Trials: While mostly observational, these studies assess the impact of modern packaging on ease of use and adherence. The transition to plastic, which reduces breakage risk and facilitates transportation, is associated with improved compliance metrics [3].

Regulatory and Safety Investigations

Regulatory bodies, including the FDA and EMA, continue to monitor the safety of plastic-packaged antibiotics. A key concern remains potential leaching of plasticizers or monomers, which could affect drug safety and stability. The FDA’s recent guidance emphasizes strict testing protocols, which have been successfully met by manufacturers adopting compatible plastics such as polypropylene and polyethylene [4].

---

Market Analysis

Current Market Dynamics

The global antibiotic market, estimated at USD 52.5 billion in 2022, exhibits sustained growth driven by increasing infectious disease prevalence, antimicrobial resistance (AMR), and healthcare infrastructure expansion in emerging markets [5].

Vancocin Hydrochloride accounts for a significant share within hospital antibiotics, particularly in ICU settings. Traditionally supplied in glass bottles, the shift toward plastic containers offers several advantages:

• Operational Efficiency: Plastic containers reduce breakage, simplify handling, and decrease sterilization and transport costs.
• Enhanced Safety: Reduced risk of injury during handling.
• Environmental Impact: Recyclable plastics align with sustainability goals and reduce glass waste.

Market Share and Competitive Position

Leading manufacturers such as Eli Lilly, which markets Vancocin, and generic producers dominate the landscape. The transition to plastic containers has accelerated post-2020, with an estimated 70-80% adoption in developed markets like North America and Europe. This shift is projected to continue, with some regions adopting biodegradable plastics to meet environmental regulations.

Regulatory and Supply Chain Challenges

Manufacturers face hurdles including:

• Ensuring compatibility of vancomycin with plastic materials.
• Meeting stringent quality standards for medical plastics.
• Navigating approvals across diverse regional regulatory frameworks.

Supply chain disruptions, especially during pandemic peaks, have temporarily impacted availability but are expected to stabilize as manufacturing processes adapt.

---

Future Market Projections

Growth Trends and Forecasts

Analysts forecast the global Vancocin Hydrochloride market (including plastic packaging) will grow at a Compound Annual Growth Rate (CAGR) of approximately 6.2% from 2023 to 2030 [5]. Factors influencing this include:

• Expanding Antimicrobial Resistance (AMR): Heightened demand for effective antibiotics.
• Innovation in Packaging: Adoption of advanced plastics improves stability, shelf-life, and handling.
• Increased Healthcare Spending: Especially in developing regions expanding infectious disease treatment capabilities.

Innovation and R&D Focus

Future developments are expected to include:

• Smart Packaging: Incorporation of sensors to monitor drug stability and expiration.
• Biodegradable Plastics: To align with environmental regulations and sustainability initiatives.
• Pre-Filled Syringes and Convenience Units: Enhancing usability and reducing preparation errors.

Market Penetration and Geographic Expansion

Emerging markets such as Asia-Pacific and Latin America exhibit significant growth potential, driven by rising hospital infrastructure investments and increased access to advanced antibiotics. The plastic container format is poised to dominate these regions due to logistical advantages.

---

Strategic Implications for Stakeholders

• Manufacturers: Must invest in R&D for compatibility and stability of vancomycin in advanced plastics, while ensuring regulatory compliance.
• Healthcare Providers: Should prefer suppliers offering validated plastic formulations, emphasizing safety and ease of use.
• Investors: Opportunities lie in companies pioneering innovative packaging that enhances product safety and sustainability.
• Regulators: Need ongoing oversight to ensure that plastic packaging meets safety standards, minimizing risk of leaching or contamination.

---

Key Takeaways

• Clinical Evidence Supports Safety and Stability: Current trials confirm that vancomycin hydrochloride retains efficacy and safety in plastic containers, facilitating broader adoption.
• Market Shift Accelerates: Transition from glass to plastic packaging is driven by operational efficiency, safety, and environmental considerations, capturing nearly 80% market share in mature markets.
• Innovation Will Drive Growth: Advanced packaging solutions, including smart, biodegradable plastics, are poised to further enhance product appeal and compliance.
• Emerging Markets Offer Growth Opportunities: Rising healthcare investments make developing regions attractive for expansion of plastic-packaged Vancocin.
• Regulatory Vigilance Is Essential: Ongoing oversight ensures safety, especially concerning plastic material compatibility and leaching risks.

---

FAQs

1. What advantages does plastic packaging offer for Vancocin Hydrochloride?
Plastic containers reduce breakage, allow easier handling, lower transportation costs, and improve safety. They also facilitate innovations like pre-filled syringes and smart packaging.

2. Are there safety concerns associated with plastic containers for vancomycin?
Regulatory agencies rigorously evaluate potential leaching of plastics. Current studies show that appropriate plastics maintain drug stability without significant leaching, but ongoing monitoring remains essential.

3. How does the clinical efficacy of Vancocin in plastic containers compare to traditional glass containers?
Studies indicate no difference in efficacy or safety profiles, with stability and bioavailability maintained over shelf life in approved plastics.

4. Which regions are leading the shift toward plastic packaging for Vancocin?
North America and Europe are at the forefront, with rapid adoption driven by improved logistics and safety benefits. Emerging markets are increasingly transitioning, aligning with healthcare infrastructure growth.

5. What future innovations are expected in Vancocin packaging?
Smart packaging with real-time stability monitoring, biodegradable plastics, and user-friendly pre-filled formats are on the horizon, supporting patient safety and sustainability.

---

References

[1] Pharmaceutics. (2022). Stability of Vancomycin in Polyolefin Containers.

[2] European Clinical Trials Database. (2023). Bioequivalence Study of Vancomycin Formulations.

[3] Journal of Patient Compliance. (2022). Impact of Packaging on Antibiotic Adherence.

[4] FDA Guidance Document. (2021). Assessing Plastic Packaging for Parenteral Drugs.

[5] MarketsandMarkets. (2023). Antimicrobial Market Forecast to 2030.

---

This analysis offers strategic insights into the evolving landscape of Vancocin Hydrochloride in plastic containers, highlighting clinical validation, market trends, and future innovation trajectories critical for decision-makers.