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Last Updated: June 21, 2025

CLINICAL TRIALS PROFILE FOR CEFAZOLIN SODIUM


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All Clinical Trials for Cefazolin Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00867295 ↗ Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device Completed Istanbul University Phase 3 2008-09-01 This randomized trial is determining the role of antibiotic prophylaxis in the prevention of the infectious complications in patients carrying out totally implantable venous access device.
NCT01127880 ↗ Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax Completed St. Luke's Hospital, Pennsylvania Phase 2/Phase 3 2005-07-01 The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.
NCT01273818 ↗ Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair Completed Diskapi Teaching and Research Hospital Phase 4 2011-01-01 Aim of this study is to measure the effectiveness of topical gentamicin to prevent post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is, if it is effective as a prophylactic agent, to compare it's effect with intra venous single dose cefazolin sodium prophylaxis.
NCT01805856 ↗ Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery Completed Ito Hospital N/A 2010-11-01 The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefazolin Sodium

Condition Name

Condition Name for Cefazolin Sodium
Intervention Trials
Surgical Site Infection 2
Atrial Fibrillation 1
Thyroid Disease 1
Cesarean Section Complications 1
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Condition MeSH

Condition MeSH for Cefazolin Sodium
Intervention Trials
Surgical Wound Infection 3
Infections 2
Infection 2
Hemothorax 1
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Clinical Trial Locations for Cefazolin Sodium

Trials by Country

Trials by Country for Cefazolin Sodium
Location Trials
Turkey 2
Brazil 1
Japan 1
United States 1
Egypt 1
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Trials by US State

Trials by US State for Cefazolin Sodium
Location Trials
Pennsylvania 1
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Clinical Trial Progress for Cefazolin Sodium

Clinical Trial Phase

Clinical Trial Phase for Cefazolin Sodium
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Cefazolin Sodium
Clinical Trial Phase Trials
Completed 6
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Cefazolin Sodium

Sponsor Name

Sponsor Name for Cefazolin Sodium
Sponsor Trials
University of British Columbia 1
Istanbul University 1
St. Luke's Hospital, Pennsylvania 1
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Sponsor Type

Sponsor Type for Cefazolin Sodium
Sponsor Trials
Other 9
Industry 1
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Cefazolin Sodium: Clinical Trials Updates, Market Analysis, and Projections

Introduction to Cefazolin Sodium

Cefazolin sodium is a first-generation cephalosporin antibiotic widely used to treat various bacterial infections, including those of the skin, bones, joints, genital, respiratory, and urinary tracts. It is also commonly used for surgical prophylaxis to prevent infections in patients undergoing surgery.

Clinical Trials Updates

Recent updates in the clinical trials and drug labeling of cefazolin sodium are significant for both healthcare providers and patients.

Prothrombin Activity and Pediatric Use

The approved drug label for cefazolin sodium in plastic containers has been updated to detail alterations in prothrombin activity. This update includes clinical trial data, adverse reactions, and safety and efficacy information when used in pediatric patients for perioperative prophylaxis. The Clinical Trials Experience and Pediatric Use sections have been revised to reflect these changes[1].

Intraoperative Serum and Tissue Activity

A study published in the Archives of Surgery compared the intraoperative serum and tissue concentrations of cefazolin and cefoxitin in patients undergoing cholecystectomies. The study found that cefazolin was detectable in wound tissue at wound closure in all patients, whereas cefoxitin was detectable in only 86% and 38% of patients when administered with anesthesia and on call, respectively. This suggests that cefazolin can be administered on call without the need for readministration for at least four hours, unlike cefoxitin which requires more frequent administration[4].

Market Analysis

The global cefazolin sodium market is experiencing significant growth driven by several key factors.

Market Size and Growth

As of 2023, the global cefazolin sodium market was valued at USD 100 million and is projected to reach USD 147 million by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031. This growth is attributed to the increasing prevalence of bacterial infections, rising rates of hospital-acquired infections, and an increase in surgical operations worldwide[2][5].

Segmentation

The market is segmented based on application, product, and geographical regions.

Application

Cefazolin sodium is used in various applications, including bacterial infections, surgical prophylaxis, respiratory tract infections, urinary tract infections, and skin infections. Surgical prophylaxis and the treatment of bacterial infections are the primary drivers of market growth[2][5].

Product

The market is segmented into different product forms such as powder for injection, lyophilized powder, vials, ampoules, and pre-filled syringes. These various formulations cater to different clinical needs and patient preferences[2].

Geographical Regions

The Asia-Pacific region is anticipated to hold the major share in the global cefazolin sodium market due to increasing research and development activities in the healthcare sector, the presence of key market players, and government initiatives supporting the development of new drugs in countries like China and India[5].

Market Drivers

Several factors are driving the growth of the cefazolin sodium market.

Increasing Prevalence of Infectious Diseases

The global rise in infectious diseases, particularly bacterial infections, is a significant driver. Cefazolin sodium's effectiveness in treating these infections makes it a preferred choice in clinical settings[2][5].

Surgical Prophylaxis

The increasing number of surgical operations worldwide has boosted the demand for cefazolin sodium as a preventive measure against post-surgical infections[2][5].

Improvements in Healthcare Infrastructure

Advancements in healthcare infrastructure, especially in emerging economies, have improved access to healthcare services, thereby increasing the demand for antibiotics like cefazolin sodium[2].

Strategic Partnerships and R&D

Major pharmaceutical companies are investing in research and development to improve the efficacy and minimize the side effects of cefazolin sodium. Strategic partnerships among these companies are also contributing to market growth[2].

Market Restraints

Despite the positive growth trends, there are some restraints to consider.

Side Effects

Side effects such as diarrhea and loss of appetite are some of the restraining factors for the growth of the global cefazolin sodium market[5].

Antimicrobial Resistance

The rising human resistance to antimicrobial drugs is a significant concern. According to the CDC, around 2 million people die every year globally due to antimicrobial drug resistance, which could impact the long-term growth of the cefazolin sodium market[5].

Impact of COVID-19 Pandemic

The COVID-19 pandemic had a mixed impact on the cefazolin sodium market.

Supply Chain Disruptions

The pandemic caused disruptions in the supply chain of raw materials, particularly from China, which delayed the manufacturing of cefazolin sodium. However, the demand for the drug remained high as it was used in intensive care units to treat COVID-19 patients[5].

Regional Outlook

The global cefazolin sodium market is segmented geographically into North America, Europe, Asia-Pacific, and the Rest of the World.

Asia-Pacific Region

The Asia-Pacific region is expected to hold the major share in the global market due to the presence of key market players, government initiatives, and the supply of key ingredients from emerging countries like China and India[5].

Market Players Outlook

Key market players such as CSPC Pharmaceutical Group Ltd. and LKPC Pharmaceutical Co. Ltd. are driving the growth in the Asia-Pacific region through their research and development activities and strategic partnerships.

Key Takeaways

  • Clinical Trials: Recent updates include detailed alterations in prothrombin activity and pediatric use, as well as intraoperative serum and tissue activity comparisons with other antibiotics.
  • Market Growth: The global cefazolin sodium market is projected to grow at a CAGR of 5% from 2024 to 2031, driven by increasing bacterial infections and surgical operations.
  • Segmentation: The market is segmented by application, product, and geographical regions, with the Asia-Pacific region expected to hold the major share.
  • Drivers: Increasing prevalence of infectious diseases, surgical prophylaxis, improvements in healthcare infrastructure, and strategic partnerships are key drivers.
  • Restraints: Side effects and antimicrobial resistance are significant restraints.
  • COVID-19 Impact: The pandemic caused supply chain disruptions but increased demand in intensive care units.

FAQs

What is cefazolin sodium used for?

Cefazolin sodium is used to treat various bacterial infections, including skin, bone, joint, genital, respiratory, and urinary tract infections. It is also used for surgical prophylaxis to prevent post-surgical infections.

What are the key drivers of the cefazolin sodium market?

The key drivers include the increasing prevalence of infectious diseases, rising rates of hospital-acquired infections, and an increase in surgical operations worldwide. Improvements in healthcare infrastructure and strategic partnerships among pharmaceutical companies also contribute to market growth.

What are the potential restraints on the cefazolin sodium market?

Side effects such as diarrhea and loss of appetite, as well as the rising human resistance to antimicrobial drugs, are significant restraints on the market.

How did the COVID-19 pandemic impact the cefazolin sodium market?

The pandemic caused disruptions in the supply chain of raw materials but increased the demand for cefazolin sodium in intensive care units to treat COVID-19 patients.

Which region is expected to hold the major share in the global cefazolin sodium market?

The Asia-Pacific region is anticipated to hold the major share in the global cefazolin sodium market due to increasing research and development activities, the presence of key market players, and government initiatives in countries like China and India.

What is the projected market size of cefazolin sodium by 2031?

The global cefazolin sodium market is projected to reach USD 147 million by 2031, growing at a CAGR of 5% from 2024 to 2031.

Sources

  1. Coram: Drug Labeling Updates – February 2024.
  2. Market Research Intellect: Global Cefazolin Sodium Market Size and Projections.
  3. Cognitive Market Research: Cefazolin Sodium Market Report 2024 (Global Edition).
  4. JAMA Network: Intraoperative Serum and Tissue Activity of Cefazolin and Cefoxitin.
  5. OMR Global: Cefazolin Sodium Market Trends, Share, Global Industry Report and Forecast.
Last updated: 2025-01-01

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