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.
NCT02225821 ↗	Wound Infections Following Implant Removal	Completed	AO Research Fund	Phase 4	2014-11-01	In the Netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWIs) should be less than 5%. However, rates of 10-12% following implant removal, specifically after foot, ankle and lower leg fractures are reported. Currently, surgeons decide individually if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in patients scheduled for implant removal following a foot, ankle or lower leg fracture, to assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome at 30 days and 6 months after implant removal and costs. With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided alpha=5%, including 15% lost to follow up). If the assumption of the investigators, that prophylactic antibiotics prior to implant removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of care. This will reduce the incidence of POWIs and consequently will lead to less physical and social disabilities and health care use. In addition, it will decrease the rate of use of empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of €3.5 million per year.

Clinical Trial Conditions for Kefzol

Condition Name

Condition Name for Kefzol
Intervention	Trials
Infection Secondary to Surgical Procedure	1
Lower Urinary Tract Discomfort	1
Prophylaxis	1
Stent Pain	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
Tan Tock Seng Hospital	1
Universidade do Vale do Sapucai	1
John Hunter Hospital	1

Sponsor Type

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

Cefazolin Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Cefazolin Sodium

Cefazolin sodium, a first-generation cephalosporin antibiotic, is widely used for treating various bacterial infections and as a prophylactic measure in surgical procedures. Here, we will delve into recent clinical trials, market analysis, and future projections for this essential antibiotic.

Clinical Trials Update

Impact of Tourniquet Use on Cefazolin Concentrations

A recent randomized clinical trial published in JAMA Network Open highlighted the significant impact of tourniquet use on the local tissue concentrations of cefazolin during total knee arthroplasty (TKA)[1].

• Key Findings: The study revealed that the use of a tourniquet resulted in significantly lower concentrations of cefazolin in fat, synovium, and bone by 60 minutes after infusion. The mean concentrations in these tissues were insufficient to cover pathogens with elevated minimum inhibitory concentrations.
• Implications: This study raises concerns about the effectiveness of cefazolin against certain pathogens when a tourniquet is used, suggesting a need for revised dosing regimens or alternative antibiotics in such scenarios.

Cefazolin Inoculum Effect (CzIE) in MSSA Infections

Another study focused on the clinical significance of the cefazolin inoculum effect (CzIE) in serious methicillin-susceptible Staphylococcus aureus (MSSA) infections. The inoculum effect refers to the reduced efficacy of antibiotics against high bacterial loads[4].

• Key Findings: The study found no statistically significant difference in mortality or treatment failure between MSSA infections with and without CzIE when treated with cefazolin. However, the evidence was limited by the heterogeneity and small size of the observational studies.
• Implications: The study suggests that CzIE testing may not be necessary in clinical practice for MSSA infections treated with cefazolin, but more robust studies are needed to confirm these findings.

Market Analysis

Global Market Size and Growth

The global cefazolin sodium market has been experiencing significant growth driven by several factors:

• Current Market Size: As of 2023, the global cefazolin sodium market was valued at USD 100 million[3].
• Growth Projections: The market is expected to reach USD 147 million by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031[3].

Regional Analysis

The market is segmented into several regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region is experiencing growth due to various factors:

• North America and Europe: These regions are driven by advanced healthcare infrastructure and high demand for efficient antibiotics.
• Asia-Pacific and Emerging Markets: Rising healthcare spending, better access to healthcare services, and an aging population are driving growth in these regions[3].

Application and Product Segmentation

Cefazolin sodium is used in various applications, including:

• Bacterial Infections: It is a first-line antibiotic for treating a range of bacterial infections.
• Surgical Prophylaxis: It is widely used to prevent infections during surgical procedures.
• Respiratory, Urinary, and Skin Infections: It is effective against infections in these areas[3].

The market is also segmented by product form, including powder for injection, lyophilized powder, vials, ampoules, and pre-filled syringes.

Key Players and Strategies

Major companies such as Acs Dobfar Spa and Olon are focusing on strategic partnerships and research and development to enhance product efficacy and minimize adverse effects. These efforts are crucial for maintaining market competitiveness and addressing the growing demand for antibiotics[2].

Market Drivers and Opportunities

Increasing Demand for Antibiotics

The rising prevalence of bacterial infections and the need for efficient preventive antibiotics in surgical settings are major drivers of the cefazolin sodium market. The aging global population, which is more prone to illnesses, further increases demand[3].

Improvements in Healthcare Infrastructure

Advancements in healthcare infrastructure, especially in emerging economies, are supporting market growth. Strict regulations promoting the use of safe and efficient antibiotics also contribute to the market's positive trajectory[3].

Technological Advancements

Developments in drug formulations and production processes are enhancing the efficacy and safety of cefazolin sodium. These advancements are expected to continue driving market growth in the coming years[2].

Market Restraints and Challenges

Antibiotic Resistance

The ongoing development of antibiotic resistance is a significant challenge for the cefazolin sodium market. This necessitates continuous research and development to ensure the antibiotic remains effective against evolving bacterial strains[3].

Regulatory Hurdles

Strict regulatory environments can pose challenges for new product approvals and market entry. Compliance with these regulations is crucial for maintaining market presence[2].

Future Projections

Market Size and CAGR

The global cefazolin sodium market is anticipated to grow at a CAGR of 5% from 2024 to 2031, reaching a market size of USD 147 million by 2031[3].

Regional Growth

Asia-Pacific and emerging markets are expected to see significant growth due to increasing healthcare spending and better access to healthcare services. North America and Europe will continue to drive demand due to their advanced healthcare infrastructure[3].

Product Innovations

Future market growth will be driven by innovations in product formulations and delivery systems. Pre-filled syringes and other convenient forms are expected to gain popularity, enhancing patient compliance and treatment outcomes[2].

Key Takeaways

• Clinical Trials: Recent trials highlight the impact of tourniquet use on cefazolin concentrations and the limited significance of CzIE in MSSA infections.
• Market Growth: The global cefazolin sodium market is growing at a CAGR of 5%, driven by increasing demand for antibiotics, improvements in healthcare infrastructure, and technological advancements.
• Regional Analysis: Asia-Pacific and emerging markets are expected to see significant growth, while North America and Europe remain key drivers.
• Product Innovations: Future growth will be driven by innovations in product formulations and delivery systems.

FAQs

What is the current market size of the global cefazolin sodium market?

The global cefazolin sodium market was valued at USD 100 million in 2023[3].

What is the projected growth rate of the cefazolin sodium market from 2024 to 2031?

The market is expected to grow at a CAGR of 5% from 2024 to 2031[3].

What are the main drivers of the cefazolin sodium market?

The main drivers include increasing demand for antibiotics, improvements in healthcare infrastructure, and technological advancements in drug formulations[3].

How does the use of a tourniquet affect cefazolin concentrations during surgery?

The use of a tourniquet significantly reduces the local tissue concentrations of cefazolin, potentially affecting its efficacy against certain pathogens[1].

Is CzIE testing necessary for MSSA infections treated with cefazolin?

Current evidence does not support the necessity of CzIE testing in clinical practice for MSSA infections treated with cefazolin[4].

Which regions are expected to drive the growth of the cefazolin sodium market?

Asia-Pacific and emerging markets, along with North America and Europe, are expected to drive market growth due to various factors including healthcare spending and infrastructure improvements[3].

Sources

1. Tourniquet Use and Local Tissue Concentrations of Cefazolin: JAMA Network Open, 2024.
2. Cefazolin Sodium Market Report 2024 (Global Edition): Cognitive Market Research.
3. Cefazolin Sodium Market Size and Projections: Market Research Intellect.
4. Clinical significance of cefazolin inoculum effect in serious MSSA infections: Journal of Antimicrobial Chemotherapy, 2024.