CLINICAL TRIALS PROFILE FOR CEFAZOLIN AND DEXTROSE

All Clinical Trials for CEFAZOLIN AND DEXTROSE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00108433 ↗	Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections	Terminated	Pfizer	Phase 3	2005-09-01	This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
NCT00130754 ↗	Thymoglobuline in Non-myeloablative Allogeneic Stem-cell Transplantation	Completed	Hadassah Medical Organization	Phase 3	2005-02-01	Allogeneic stem cell transplantation is the treatment of choice for a growing number of malignant and non-malignant indications. Until recently, myeloablative in conjunction with immunosuppressive conditioning was considered mandatory for the elimination of malignant hematopoietic cells and to prevent graft rejection. The aim of allogeneic non-myeloablative stem cell transplantation (NST) is to induce host-to-graft tolerance with fast and durable engraftment of donor stem cells, by means of conditioning, which is well-tolerated by patients. The rationale behind the NST strategy is to induce optimal graft-versus-leukemia (GVL) effects for the elimination of all malignant cells by alloreactive immunocompetent cells from a matched donor as an alternative to standard high-dose myeloablative chemo radiotherapy. The NST protocol is therefore mainly based on immunosuppression and thus contains fludarabine, low dose busulfan and anti-T-lymphocyte globulin (ATG). Thymoglobuline is a polyclonal rabbit antiserum specific for human T cells used in organ transplantation for induction of tolerance and rejection prevention and treatment. It was also used in stem-cell transplantation (SCT) for the same purposes (e.g. for generation of tolerance and rejection preclusion) as well as a treatment for graft-versus-host disease (GVHD). Data from myeloablative protocols suggest that ATG before SCT significantly reduces the risk for grade III-IV acute GVHD. This does not translate to a reduction in transplant-related mortality (TRM) because of the increased risk for infections and thus survival is unchanged. Extensive chronic GVHD was also significantly shown to be reduced in patients receiving ATG in the myeloablative setting. However, the role of ATG in the NST protocol was never evaluated in a prospective randomized trial. In view of the preliminary data suggesting of an additive effect of ATG in these circumstances we, the investigators at Hadassah Medical Organization, evaluate the effect of ATG in NST by a prospective randomized trial.
NCT00323219 ↗	Oral Moxifloxacin Versus Cefazolin and Oral Probenecid in the Management of Skin and Soft Tissue Infections in the Emergency Department	Unknown status	University of British Columbia	Phase 3	2004-01-01	Patients often come to the emergency department with bacterial skin infections (known as "cellulitis"). Some patients with very severe infections are admitted to hospital for antibiotic treatment and some are sent home on oral antibiotics. Many patients have moderate infections and are treated as outpatients with daily intravenous antibiotics for 2-5 days. In this patient group it is unclear if treatment with oral antibiotics is as effective as intravenous antibiotics. The purpose of this study is to determine if treatment of moderate cellulitis with an intravenous antibiotic (cefazolin) for 3-5 days is as effective as treatment with an oral antibiotic (moxifloxacin). We hypothesize that the oral agent will be as effective as intravenous treatment for moderate cellulitis.
NCT00330278 ↗	Timing of Prophylactic Antibiotics for Cesarean Sections	Completed	Medical University of South Carolina	N/A	2003-01-01	This is a randomized, double-blinded placebo controlled trial of cefazolin timing before cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30 minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious morbidity including wound infections and endometritis.
NCT00467948 ↗	Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients	Completed	Tehran University of Medical Sciences	Phase 3	2004-06-01	Patients who need major head & neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists in the optimal antibiotic regimen
NCT00550290 ↗	Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy	Completed	Aultman Health Foundation	Phase 4	2007-10-01	This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.
NCT00610987 ↗	Antibiotic Prophylaxis in Orthopaedic Traumatology	Completed	University of Missouri-Columbia	N/A	2008-01-01	It has been established that providing antibiotic prophylaxis after closed fracture fixation with implants or prosthetic devices has beneficial effects. However, the optimal duration of antibiotic prophylaxis after orthopaedic trauma surgery is not well-defined. Most studies comparing single-dose prophylaxis with multiple-dose prophylaxis have not shown beneficial effects of additional doses. Our proposed study is intended to further define the appropriate duration of antibiotic (cefazolin) administration for surgical prophylaxis in the treatment of closed fractures. We will randomly assigned patients into two groups, hopefully differentiated only by the duration of antibiotic administration (single dose vs. 24 hours). We will follow these patients until fracture healing and determine if there is a difference in the incidence of infection.

Clinical Trial Conditions for CEFAZOLIN AND DEXTROSE

Condition Name

Condition Name for CEFAZOLIN AND DEXTROSE
Intervention	Trials
Surgical Site Infection	16
Infection	8
Obesity	7
Wound Infection	6

Condition MeSH

Condition MeSH for CEFAZOLIN AND DEXTROSE
Intervention	Trials
Infections	40
Infection	29
Surgical Wound Infection	28
Communicable Diseases	22

Clinical Trial Locations for CEFAZOLIN AND DEXTROSE

Trials by Country

Trials by Country for CEFAZOLIN AND DEXTROSE
Location	Trials
United States	134
Canada	24
Brazil	10
Australia	10
Israel	8

Trials by US State

Trials by US State for CEFAZOLIN AND DEXTROSE
Location	Trials
Texas	11
New York	9
California	9
Pennsylvania	8
North Carolina	7

Clinical Trial Progress for CEFAZOLIN AND DEXTROSE

Clinical Trial Phase

Clinical Trial Phase for CEFAZOLIN AND DEXTROSE
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	3
PHASE2	3

Clinical Trial Status

Clinical Trial Status for CEFAZOLIN AND DEXTROSE
Clinical Trial Phase	Trials
COMPLETED	70
RECRUITING	33
Unknown status	22

Clinical Trial Sponsors for CEFAZOLIN AND DEXTROSE

Sponsor Name

Sponsor Name for CEFAZOLIN AND DEXTROSE
Sponsor	Trials
B. Braun Medical Inc.	4
Duke University	4
Population Health Research Institute	4

Sponsor Type

Sponsor Type for CEFAZOLIN AND DEXTROSE
Sponsor	Trials
Other	239
Industry	20
NIH	7

CEFAZOLIN AND DEXTROSE Market Analysis and Financial Projection

Last updated: April 23, 2026

CEFAZOLIN AND DEXTROSE: Clinical Trial Update, Market Analysis, and 2026-2031 Projection

CeFAZolin and dextrose is a fixed-dose parenteral regimen used to deliver cephalosporin (ceFAZolin) with dextrose as a formulation component. The clinical and commercial profile is dominated by (1) generic availability of ceFAZolin injection and (2) hospital formulary demand for perioperative and infection-management indications, where the dextrose component is not a separate therapeutic driver. Public clinical activity and monetizable patent estate are therefore concentrated on formulation-level IP rather than on a novel drug mechanism.

Because “CEFAZOLIN AND DEXTROSE” is best treated as an injection product category rather than a standalone new molecular entity, the market outlook is anchored to ceFAZolin injection volume trends, procurement cycles, and generic pricing rather than to de novo platform adoption.

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What is the clinical trial status for ceFAZolin and dextrose?

Trial landscape (what is measurable in public records)

Publicly searchable trial registries and sponsor announcements typically index ceFAZolin by active ingredient and route (IV/IM) rather than by explicit “with dextrose” pairing. Where “dextrose” appears, it is usually linked to the solvent system and does not change dosing goals or efficacy endpoints relative to ceFAZolin injection products.

Implication for decision-making: trial updates for “ceFAZolin + dextrose” should be treated as trial updates for ceFAZolin injection broadly (e.g., perioperative prophylaxis, surgical site infection prevention, empiric therapy for susceptible pathogens). Net-new clinical value from the dextrose pairing is unlikely to be independently demonstrated because it is not a separate active ingredient.

What endpoints are consistently used for ceFAZolin injection trials

Across perioperative prophylaxis and infection indications, trial endpoints typically include:

• Incidence of surgical site infections (SSI)
• Microbiologic eradication or culture conversion (in infection studies)
• Safety endpoints such as nephrotoxicity, hypersensitivity, and infusion reactions
• Pharmacokinetic exposure endpoints (less common in routine formulation-only work)

Current read-through for “clinical update”

There is no evidence of a widely recognized, late-stage “ceFAZolin and dextrose” development program that functions as a distinct registrable innovation separate from ceFAZolin injection generics. The practical clinical update is therefore procurement-driven rather than pipeline-driven: hospitals update use based on resistance patterns, stewardship guidance, and formulary economics.

Operational conclusion: treat “clinical trial update” as the continuation of mainstream ceFAZolin injection evidence rather than as a distinct trial pipeline.

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How does ceFAZolin injection reach the market?

Regulatory and supply model

CeFAZolin injection is a mature antibiotic with broad generic penetration in major markets. Product differentiation typically comes from:

• Solvent system and excipients
• Concentration and fill volume
• Container format and stability profile
• Manufacturing process and bioequivalence to listed reference products

Demand drivers

Hospital demand for ceFAZolin injection is anchored to:

• Surgical prophylaxis protocols (orthopedics, general surgery, cardiothoracic where indicated)
• Treatment of skin/soft tissue infections and other susceptible bacterial infections
• Antimicrobial stewardship policies that prefer narrow-spectrum cephalosporins when appropriate

Reimbursement and purchasing pattern

Purchasing is mostly governed by:

• Hospital group purchasing organization (GPO) formularies
• Tendering and price competition among generics
• Stock availability and supply continuity

Dextrose as an excipient does not materially shift reimbursement codes when compared across generic ceFAZolin injection presentations, unless it creates a clinically meaningful stability or administration workflow difference.

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Market analysis: size, price mechanics, and competitive structure

Competitive set

The competitive set for “ceFAZolin and dextrose” is essentially the broader ceFAZolin injection generic field, which includes multiple branded and generic manufacturers across regions.

Key competition levers:

• Unit price in tenders
• Supply reliability and lead times
• Presentation (concentration, vial size, reconstitution time, stability)
• Compatibility with institutional IV workflows (where excipient and formulation details can matter)

Pricing mechanics

For mature generic injectables:

• Price declines as market share shifts to lowest-cost tender winners
• Shortage periods can temporarily lift effective procurement prices
• Drug wholesaler markups and distribution costs can dominate observed “retail” pricing

Projection basis: market value growth is more likely to be driven by volume stability plus price volatility (shortages and procurement rebalancing) rather than sustained unit price growth.

Market segmentation that matters

For ceFAZolin injection, segmentation that impacts demand forecasting:

• Inpatient surgical prophylaxis utilization
• ICU and emergency empiric pathways (where susceptibility supports use)
• Geographic healthcare spending and surgery volumes
• Antimicrobial stewardship guidelines
• Pandemic or seasonal impacts on surgical volumes (less relevant to “dextrose” product form)

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Projection for 2026-2031: what to expect for ceFAZolin and dextrose

Base-case logic (how volume and value likely move)

1. Volume: ceFAZolin injection remains embedded in perioperative prophylaxis. Volume tracks surgical volumes and hospital prescribing patterns, which are generally stable over multi-year horizons.
2. Price: generic pricing compresses structurally over time, with periodic spikes during supply disruptions. Over a 5-year horizon, net value growth is usually modest and often lags inflation.
3. Mix: shifts across vial sizes and concentrations can affect reported revenue without changing underlying prescribing prevalence.

2026-2031 market projection (scenario range)

Because “ceFAZolin and dextrose” is not typically priced as a distinct revenue line item separate from ceFAZolin injection, the market projection should be modeled as a share of the ceFAZolin injection generic market.

A pragmatic projection range:

• Base-case (steady demand, continued generic price compression): mid-single-digit CAGR in value, low-single-digit in unit volume terms
• Upside (tender-driven price resilience from supply tightness): low-double-digit value CAGR, volume near-flat
• Downside (accelerated price erosion and substitution to alternative cephalosporins or other prophylaxis regimens): low-single-digit value CAGR, some volume softness

What changes would break the model

The model shifts if:

• A new ceFAZolin formulation with meaningful clinical advantages obtains strong guideline adoption
• A supply-side shock causes prolonged replacement procurement from higher-cost sources
• Resistance patterns drive guideline shifts away from first-generation/cefazolin-centric prophylaxis for specific surgeries

No distinct dextrose-driven shift is expected because dextrose is not an active therapeutic determinant.

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Patent and regulatory exclusivity: does “ceFAZOLIN + DEXTROSE” have defensible IP?

Patent reality for mature cephalosporins

For ceFAZolin injection, defensibility typically resides in:

• Process patents (manufacturing process)
• Formulation patents (excipients, stability, container closure systems)
• Method-of-use claims (less common for mature prophylaxis agents due to obviousness risk)
• Polymorph/crystal form claims (usually irrelevant for injections unless solid form differs)

Practical IP conclusion

For a “ceFAZOLIN AND DEXTROSE” pairing, the most monetizable exclusivity is likely to be product-specific at the formulation and process level. In a generic-heavy category, that exclusivity is usually narrow and time-limited, and it does not create broad commercial insulation.

Investment takeaway: model returns as a function of formulation differentiation and procurement execution, not as a de novo molecule pathway.

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Business implications: how to use this analysis in R&D and investment

If you are evaluating product development

• Build differentiation around stability, reconstitution workflow, and supply continuity.
• Treat dextrose as a formulation parameter, not a competitive “active” claim.
• Target institutions through GPO and tender pipelines with clear total cost of administration arguments.

If you are evaluating manufacturing or sourcing

• Track tender cycles and availability by concentration and vial size.
• Stress-test supply against API and sterile fill-finish capacity constraints.
• Monitor competitive pricing moves from incumbents and newly launched generics.

If you are evaluating portfolio strategy

• Expect incremental competitive entry to pressure pricing.
• Focus on defensible presentation formats and manufacturing quality systems rather than broad IP.

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Key Takeaways

• “CEFAZOLIN AND DEXTROSE” behaves as a ceFAZolin injection product category; clinical updates are largely inseparable from the mature ceFAZolin injection evidence base.
• Market demand is driven by perioperative prophylaxis and hospital inpatient use; dextrose is typically an excipient-level component without independent therapeutic differentiation.
• Projections for 2026-2031 are constrained by generic pricing compression; value growth is likely modest and sensitive to supply disruptions and tender dynamics.
• Defensible value most often comes from formulation/process and supply execution, not from mechanism innovation or dextrose-specific clinical breakthroughs.

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FAQs

1) Is “ceFAZolin and dextrose” a separate drug from ceFAZolin injection?
In practice, it is the same active antibiotic class and is usually differentiated at formulation/excipient and presentation level rather than by a separate mechanism or clinical indication.

2) Will clinical trial endpoints for this product differ from other ceFAZolin injections?
Endpoints typically align with standard ceFAZolin perioperative and infection studies, such as SSI incidence, culture outcomes, and safety.

3) What most affects revenue in the ceFAZolin injection market?
Tender-driven pricing, supply availability, and presentation mix (vial size/concentration), rather than any excipient-driven effect.

4) What is the likely pricing direction from 2026 to 2031?
Generic price compression is the base expectation, with temporary upward pressure during shortages or supply constraints.

5) Where should R&D teams focus for differentiation?
On formulation stability, reconstitution and administration workflow, and manufacturing/process reliability that reduce total cost and improve supply consistency.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] World Health Organization. WHO Model List of Essential Medicines. https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/essential-medicines
[4] Centers for Disease Control and Prevention. Surgical Site Infection (SSI) prevention guidance. https://www.cdc.gov/infection-prevention/guidelines/ssi/
[5] Infectious Diseases Society of America (IDSA). Antimicrobial stewardship and guidance resources (as applicable to cephalosporin prophylaxis frameworks). https://www.idsociety.org/guidelines/