CLINICAL TRIALS PROFILE FOR VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

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 HYDROCHLORIDE IN PLASTIC CONTAINER

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)

Clinical Trial Conditions for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Condition Name

Condition Name for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Clostridium Difficile Infection	39
Surgical Site Infection	21
Infection	19
Bacteremia	14

Condition MeSH

Condition MeSH for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Intervention	Trials
Infections	163
Infection	141
Communicable Diseases	128
Clostridium Infections	85

Clinical Trial Locations for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Location	Trials
Canada	102
Spain	43
United Kingdom	36
Australia	34
Brazil	34

Trials by US State

Trials by US State for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Location	Trials
Texas	65
California	65
Ohio	53
Florida	51
New York	49

Clinical Trial Progress for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	4
PHASE2	16

Clinical Trial Status

Clinical Trial Status for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	194
Recruiting	94
Terminated	48

Clinical Trial Sponsors for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Sponsor	Trials
Cubist Pharmaceuticals LLC	23
Pfizer	18
Forest Laboratories	11

Sponsor Type

Sponsor Type for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Sponsor	Trials
Other	601
Industry	179
U.S. Fed	17

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Vancomycin Hydrochloride in Plastic Container: Clinical Trials Update, Market Analysis, and Price-Projection Framework

Last updated: April 24, 2026

What is the product and what is the “plastic container” significance in market terms?

“Vancomycin hydrochloride in plastic container” identifies a dosage form of vancomycin (active ingredient: vancomycin hydrochloride) supplied in a plastic infusion container (commonly a PVC-free IV bag or an elastomeric/plastic system depending on manufacturer and region). From a market and trial perspective, the plastic container typically impacts:

• Supply-chain and handling (nursing workflow, transport damage risk, storage footprint)
• Regulatory filing scope (container-closure system elements)
• Brand-level adoption and tendering (hospital procurement decisions often separate “brand + presentation” even when API is the same)

The product identity as stated is presentation-specific, so clinical-trial visibility and market sizing often track vancomycin IV products broadly (API) plus container/presentation differentiation at the brand or distributor level.

What clinical trial signals exist for vancomycin (IV) that affect this presentation?

At the level of vancomycin IV (the API), clinical development activity is dominated by:

• New dosing strategies (PK/PD optimization, AUC-guided dosing)
• Combination regimens for specific resistance phenotypes
• Comparative trials in complicated infections (hospital-acquired pneumonia, bacteremia, skin and soft tissue infections)
• Real-world evidence updates tied to stewardship protocols

However, for presentation-specific “vancomycin hydrochloride in plastic container,” trials are typically not run as head-to-head studies versus other containers because container choice rarely changes pharmacology. When container differences are assessed, they usually appear in:

• Stability and compatibility work (shelf life, leachables, infusion compatibility)
• Bioequivalence-like bridging (often not framed as “clinical trials”)
• CMC regulatory submissions rather than randomized efficacy trials

Because your request requires a “clinical trials update” and market projection tied to this exact presentation, a complete and accurate update must be grounded in public trial registries and label-level documentation for the plastic-container presentation. Without that presentation-level mapping to specific brands (and their registry identifiers), producing a precise trial update would not meet accuracy standards.

What can be concluded from the available public information without presentation-level trial mapping?

None. A presentation-specific “clinical trials update” and “market projection for this drug” requires:

• Named manufacturers and product presentations (bag type, configuration, NDC-style identifiers by region)
• Linked trial records or at least trial endpoints tied to that specific product presentation

If that mapping is missing, any “clinical trials update” would conflate API-level vancomycin studies with a container-specific product, and the “market projection” would mis-allocate share to the wrong SKU.

How should market analysis be structured for vancomycin in IV plastic containers?

A robust market analysis for a presentation-specific generic/brand of vancomycin should separate the market into these revenue pools:

1. Total vancomycin IV market (all presentations)
2. Plastic-container share of that market (bag adoption rate)
3. Tender-driven brand share (hospital contracting behavior by region)
4. Competitive substitution (generic interchangeability and pharmacy substitution rules)
5. Exclusivity and supply constraints (shortages, manufacturing outages)

Market sizing inputs needed (presentation-specific)

A correct model requires:

• Country/regional sales by dosage form and container
• Hospital procurement datasets that distinguish bag types or product IDs
• Tender outcomes by brand and presentation
• Competitor list by NDC/brand packaging

Without those, a numeric projection for “vancomycin hydrochloride in plastic container” would be an aggregate vancomycin projection mislabeled to a presentation.

What is the defensible projection approach if you have presentation-level sales history?

If historical sales by presentation exist, a projection model can be stated and executed as follows (framework-ready for immediate deployment once the SKU history is available):

Core projection model (monthly/quarterly)

• Base demand: infections requiring IV vancomycin, adjusted for stewardship and AUC-guided dosing uptake
• Penetration: plastic-container adoption rate (logistic curve or S-curve)
• Share: brand/presentation share via tender cycles (fixed-effect by hospital group)
• Price: net price trend driven by generic erosion and contract renewal lags
• Supply shocks: inventory availability effects with a lead-time distribution

Price projection (net sales)

Let:

• ( P_t ) = net price at time ( t )
• ( E ) = annual net price erosion rate from generic competition
• ( C_t ) = contract index (tender renewal impact)
• ( S_t ) = supply constraint indicator (shortage premium or allocation losses)

A simple projection:

• ( P_t = P_0 \times (1 - E)^{t} \times C_t \pm S_t )

Unit projection

• ( Ut = U{t-1} \times (1 + g) \times \text{PlasticShare}_t )
• ( \text{PlasticShare}t = \frac{1}{1 + e^{-k(t-t{50})}} )

Revenue

• ( R_t = P_t \times U_t )

This approach produces decision-grade projections only after anchoring ( P_0 ), ( U_0 ), and the plastic-container share series to presentation-specific data.

What investment or R&D implications follow from container-specific market mechanics?

For vancomycin IV in plastic containers, the practical implications typically map to:

• Procurement risk: tender timing can dominate short-term sales more than clinical demand
• Shelf-life and handling: competitive advantage can hinge on stability, leachables, and compatibility claims in dossiers
• CMC-driven competitiveness: manufacturing scale and bag supply affect availability and contract retention
• Substitution risk: if regulators label the API as therapeutically equivalent across presentations, the container is a procurement differentiator, not a clinical one

What actions should a company take based on the above?

If you are managing R&D or portfolio strategy for a plastic-container vancomycin presentation, the business actions that typically move outcomes are:

• Align CMC and stability package with procurement and substitution requirements in target regions
• Target hospital group tenders where bag adoption correlates with contract duration and switching costs
• Stress-test supply continuity for the bag system (container supply can be a hidden single point of failure)

These are operational levers, not clinical-development levers, because container differences usually do not drive efficacy outcomes.

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Key Takeaways

• Presentation-specific “clinical trials updates” for vancomycin in plastic containers are generally limited because container changes rarely alter pharmacology; most evidence is CMC/stability rather than randomized efficacy.
• A correct market projection must be presentation-specific (SKU-level net price, units, and plastic-container share). Without that mapping, any numeric projection would conflate API demand with the wrong product pool.
• Decision-grade forecasts for this product use a procurement-tender share model plus net price erosion and plastic-container penetration dynamics.

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FAQs

1. Do plastic-container vs vial-container differences change vancomycin dosing or efficacy?
   Typically no. Container systems are usually assessed through compatibility, stability, and CMC criteria rather than efficacy trials.

2. Why do clinical trial databases show fewer “plastic container” entries for vancomycin?
   Trials focus on API regimen and clinical outcomes; container changes usually do not trigger new clinical outcome studies.

3. What most drives hospital adoption of vancomycin in plastic containers?
   Procurement contracting, handling workflow, stability claims, and supply reliability.

4. How should pricing be modeled for a generic vancomycin presentation?
   Use net price erosion by contract renewal cycles and incorporate supply-constraint effects.

5. What is the main commercial risk for plastic-container formulations?
   Container system supply continuity and tender substitution dynamics.

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References

1. FDA. Vancomycin drug label and prescribing information resources. (Accessed via FDA Drug Labels database).
2. ClinicalTrials.gov. Vancomycin clinical trials database (query: vancomycin IV; filters by study type, condition, and recruitment status).
3. EMA. Product information and assessment documents for vancomycin-containing medicinal products (as applicable by member-state submissions).
4. WHO. Antimicrobial stewardship guidance resources (for context on vancomycin use patterns affecting demand).