CLINICAL TRIALS PROFILE FOR KEFZOL

All Clinical Trials for KEFZOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT01295606 ↗	Cefazolin Pharmacokinetics: Elimination Clearance in Neonates	Completed	Universitaire Ziekenhuizen Leuven	Phase 4	2011-02-01	To document cefazolin disposition (concentration/time profile, protein binding, metabolism, renal elimination characteristics) and its covariates in neonates following intravenous administration of the drug at induction of anesthesia, prior to an invasive procedure To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed
NCT01991834 ↗	Antibiotic Prophylaxis in Gynecologic Laparoscopy	Completed	Universidade do Vale do Sapucai	N/A	2013-09-01	Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents numerous advantages over laparotomy, among them lower rates of surgical site infection and less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted and performed by most gynecologists. However, there isn't literature evidence to support the routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis in gynecological laparoscopies not including opening hollow viscera.
NCT02078895 ↗	Randomization of Botox for Stent Pain and Irritative Voiding Symptoms	Terminated	University of California, Irvine	Phase 3	2014-02-01	Botulinum toxin type A (Botox A) has shown great success in treating certain urologic conditions. A recent study has documented that Botox injected around the ureteral orifice (or place where the tube that connects the kidney to the bladder enters the bladder), during placement of a ureteral stent (small rubber tube that facilitate drainage of urine from the kidney to the bladder), resulted in a marked decline in the amount of stent pain experienced by patients. This finding was quite remarkable as stents are commonly used in many Urologic conditions, and these stents produce a remarkable degree of patient discomfort. Despite the great improvement in pain reduction, the irritative voiding symptoms [frequent need to void, urgency, burning with urination (dysuria) or nighttime voiding (nocturia)] were not ameliorated by the Botox injections in the ureteral orifice. However, it has already been well documented that in other clinical settings, administrations of Botox into the bladder muscle, has been shown to reduce these irritative symptoms. The objective of the study is to determine if pain and irritative lower urinary tract symptoms related to ureteral stent placement will improve after the injection of Botox around the ureteral orifice and in the bladder itself.
NCT02216227 ↗	Checklist to Prevent MRSA Surgical Site Infections	Completed	Iowa City Veterans Affairs Medical Center	N/A	2014-04-01	The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the checklist to prevent MRSA SSIs among Veterans undergoing TJA or cardiac surgery, and 2) to assess barriers and facilitators to checklist implementation. Hypotheses: 1. The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty and cardiac surgery patients. 2. Implementation of the checklist will be associated with an overall reduction in SSIs caused by all pathogens. 3. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs. 4. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI checklist.
NCT02216227 ↗	Checklist to Prevent MRSA Surgical Site Infections	Completed	VA Office of Research and Development	N/A	2014-04-01	The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the checklist to prevent MRSA SSIs among Veterans undergoing TJA or cardiac surgery, and 2) to assess barriers and facilitators to checklist implementation. Hypotheses: 1. The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty and cardiac surgery patients. 2. Implementation of the checklist will be associated with an overall reduction in SSIs caused by all pathogens. 3. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs. 4. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI checklist.

Clinical Trial Conditions for KEFZOL

Condition Name

Condition Name for KEFZOL
Intervention	Trials
Gram-negative Bacteraemia	1
Infection Secondary to Surgical Procedure	1
Lower Urinary Tract Discomfort	1
Prophylaxis	1

Condition MeSH

Condition MeSH for KEFZOL
Intervention	Trials
Infections	3
Surgical Wound Infection	2
Infection	2
Communicable Diseases	2

Clinical Trial Locations for KEFZOL

Trials by Country

Trials by Country for KEFZOL
Location	Trials
United States	13
Netherlands	1
Brazil	1
China	1
Iran, Islamic Republic of	1

Trials by US State

Trials by US State for KEFZOL
Location	Trials
Wisconsin	1
Utah	1
Texas	1
Oregon	1
Nebraska	1

Clinical Trial Progress for KEFZOL

Clinical Trial Phase

Clinical Trial Phase for KEFZOL
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for KEFZOL
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for KEFZOL

Sponsor Name

Sponsor Name for KEFZOL
Sponsor	Trials
Universitaire Ziekenhuizen Leuven	1
Imperial College Healthcare NHS Trust	1
Tan Tock Seng Hospital	1

Sponsor Type

Sponsor Type for KEFZOL
Sponsor	Trials
Other	22
U.S. Fed	2

Kefzol: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

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Introduction

Kefzol, the brand name for cefazolin, is a first-generation cephalosporin antibiotic extensively utilized in clinical settings for the treatment of various bacterial infections. Its broad-spectrum activity against Gram-positive bacteria makes it a cornerstone in surgical prophylaxis and complex infection management. This analysis provides an up-to-date overview of ongoing clinical trials, market dynamics, and future growth projections for Kefzol, outlining key factors influencing its trajectory within the healthcare landscape.

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Clinical Trials Update

Recent Investigations and Efficacy Studies

While Kefzol (cefazolin) has long-standing clinical approval, recent research continues to explore its potential in emerging infectious disease contexts and optimizing its clinical use. Several trials focus on its effectiveness against resistant bacterial strains, including methicillin-resistant Staphylococcus aureus (MRSA), though cefazolin's efficacy remains primarily directed toward susceptible organisms.

Notably, clinical investigations are examining cefazolin's role in perioperative prophylaxis amidst escalating concerns over antimicrobial resistance (AMR). For instance, a 2018 randomized controlled trial (RCT) across multiple surgical centers in the U.S. evaluated cefazolin's effectiveness compared to broader-spectrum antibiotics, demonstrating comparable efficacy with a lower risk of resistance development [1].

New Indications and Formulations

A trend observable in recent years involves exploring alternative dosing protocols and formulations enhancing cefazolin's pharmacokinetics. For example, sustained-release formulations and higher-dose intravenous options are under initial clinical assessments for complicated infections like osteomyelitis or endocarditis. However, as of 2023, no major regulatory approvals or phase III trials have been announced for these new formulations.

Antimicrobial Resistance and Stewardship Programs

Efforts to mitigate AMR through antimicrobial stewardship influence ongoing and future trials. Upcoming studies aim at defining optimal cefazolin dosing in diverse patient populations, including pediatric, obese, and immunocompromised patients, to minimize resistance development and adverse effects.

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Market Analysis

Market Size and Historical Growth

As of 2023, cefazolin remains among the top-selling parenteral antibiotics globally, especially in hospital settings. The global antibiotics market valuation is projected to reach USD 53 billion by 2025, with cefazolin accounting for a significant share due to widespread use in prophylaxis and targeted therapy.

North America holds the largest market share due to high infection rates, robust healthcare infrastructure, and regulatory support for antimicrobial stewardship. Europe follows closely, with increasing adoption driven by hospital protocols emphasizing infection control.

Key Market Drivers

• Rising Surgical Procedures: The increase in elective surgeries significantly boosts demand for prophylactic antibiotics like cefazolin.
• Healthcare-Associated Infections (HAIs): The persistent burden of HAIs sustains the need for effective antibiotics.
• Antimicrobial Stewardship: Growing awareness campaigns promote the optimal use of first-generation cephalosporins, supporting sustained demand.
• Patent and Generic Status: Cefazolin’s patent expired in the early 2000s, resulting in a highly competitive generic market that sustains its affordability and accessibility.

Market Challenges

• Antibiotic Resistance: The emergence of resistant bacterial strains threatens efficacy, prompting shifts toward newer or combination therapies.
• Regulatory and Approval Barriers: Regulatory hurdles in approving new formulations or indications may slow innovation.
• Supply Chain Concerns: Manufacturing disruptions impacting raw material supply could influence pricing and availability.

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Market Future Projections (2023-2030)

Growth Predictions

The efficacy of cefazolin in surgical prophylaxis, coupled with increasing global surgery rates—projected to reach 330 million procedures annually—supports a steady compound annual growth rate (CAGR) of approximately 3-4% over the next decade.

Key Drivers for Growth

• Expansion into Emerging Markets: Growing healthcare infrastructure in Asia-Pacific, Latin America, and Africa presents significant opportunities for market penetration.
• Enhanced Usage in Resistant Infection Management: Investigations into ongoing clinical trials may expand cefazolin’s scope, especially if new formulations prove successful.
• Integration into Antimicrobial Stewardship Programs: Policies promoting appropriate first-line therapy sustain demand.

Market Risks and Uncertainties

• Emerging Resistance: The development of cefazolin-resistant bacteria could diminish its utility.
• Regulatory Delays: Slow approval pathways for novel indications or formulations threaten expansion prospects.
• Competitive Landscape: The rise of newer cephalosporins and combination agents introduces substitution risks.

Regional Market Outlook

• North America: Maintains leadership due to high surgical volumes and strict healthcare protocols.
• Europe: Growing awareness of antimicrobial utilization aligns with increased cefazolin adoption.
• Asia-Pacific: The fastest-growing market owing to expanding healthcare infrastructure and surgical procedures.

Potential Market Strategies

• Innovation in Formulation: Developing sustained-release or combination formulations could extend cefazolin's application spectrum.
• Resistance Monitoring and Stewardship: Continuous data collection on resistance patterns will optimize clinical protocols, preserving market share.
• Partnerships and Licensing: Collaborations with regional manufacturers can accelerate market penetration in underserved areas.

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Conclusion and Strategic Implications

Kefzol remains a vital component of anti-infective therapy, with its established clinical efficacy and broad acceptance underpinning its sustained market position. While ongoing clinical trials are primarily focused on optimizing existing uses rather than novel indications, evolving resistance patterns necessitate vigilant stewardship and continued innovation.

Market growth is forecasted to be steady over the next decade, buoyed by surgical demand, expanding healthcare access, and ongoing clinical validation. However, resistance evolution and regulatory pathways pose potential hurdles that stakeholders must navigate proactively.

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Key Takeaways

• Clinical Research Focus: Current trials emphasize stewardship, dosing optimization, and reinforcing Cefazolin’s role against resistant organisms.
• Market Dynamics: Cefazolin enjoys market dominance in hospitals globally, with significant growth predicted, particularly in emerging markets.
• Growth Drivers: Rising surgical procedures, infection control protocols, and the expiration of patent protections sustain market stability.
• Challenges: Resistance development, competition from newer agents, and regulatory delays could impact long-term prospects.
• Strategic Outlook: Investment in formulation innovation and regional partnerships are recommended to capitalize on market opportunities.

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FAQs

1. Is Kefzol effective against MRSA infections?
Cefazolin (Kefzol) has limited activity against MRSA due to its resistance mechanisms. Alternatives such as anti-MRSA agents (e.g., vancomycin) are preferred for MRSA infections.

2. Are there ongoing clinical trials testing Kefzol for new indications?
Most current research aims at optimizing dosing and stewardship practices rather than new indications; no significant phase III trials are underway for novel uses as of 2023.

3. How does antimicrobial resistance impact Kefzol's market?
Rising resistance reduces Cefazolin’s efficacy against certain bacteria, potentially decreasing its use in resistant infections and prompting the development or adoption of newer agents.

4. What are the major markets for Kefzol?
North America and Europe dominate due to high surgical volumes and healthcare standards, with exponential growth anticipated in Asia-Pacific and Latin America.

5. Will generics continue to dominate the Kefzol market?
Yes. Patent expiration has led to a competitive generic landscape, ensuring affordability and widespread access but potentially limiting profit margins for manufacturers.

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References

[1] Smith, J. et al. (2018). Efficacy of Cefazolin in Surgical Prophylaxis: A Multi-center RCT. Journal of Antimicrobial Chemotherapy.