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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR CEFAZOLIN IN PLASTIC CONTAINER


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All Clinical Trials for Cefazolin In Plastic Container

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
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
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for Cefazolin In Plastic Container

Condition Name

127760024681012Surgical Site InfectionInfectionObesityWound Infection[disabled in preview]
Condition Name for Cefazolin In Plastic Container
Intervention Trials
Surgical Site Infection 12
Infection 7
Obesity 7
Wound Infection 6
[disabled in preview] 0
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Condition MeSH

3829232200510152025303540InfectionsInfectionSurgical Wound InfectionCommunicable Diseases[disabled in preview]
Condition MeSH for Cefazolin In Plastic Container
Intervention Trials
Infections 38
Infection 29
Surgical Wound Infection 23
Communicable Diseases 22
[disabled in preview] 0
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Clinical Trial Locations for Cefazolin In Plastic Container

Trials by Country

+
Trials by Country for Cefazolin In Plastic Container
Location Trials
United States 130
Canada 23
Australia 10
Brazil 10
Israel 7
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Trials by US State

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Trials by US State for Cefazolin In Plastic Container
Location Trials
Texas 9
New York 9
California 9
Pennsylvania 8
North Carolina 7
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Clinical Trial Progress for Cefazolin In Plastic Container

Clinical Trial Phase

37.0%14.9%44.8%0010203040506070Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Cefazolin In Plastic Container
Clinical Trial Phase Trials
Phase 4 57
Phase 3 23
Phase 2/Phase 3 5
[disabled in preview] 69
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Clinical Trial Status

43.9%16.8%14.2%25.2%02025303540455055606570CompletedRecruitingUnknown status[disabled in preview]
Clinical Trial Status for Cefazolin In Plastic Container
Clinical Trial Phase Trials
Completed 68
Recruiting 26
Unknown status 22
[disabled in preview] 39
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Clinical Trial Sponsors for Cefazolin In Plastic Container

Sponsor Name

trials0123456789B. Braun Medical Inc.Population Health Research InstituteUniversity of Sao Paulo General Hospital[disabled in preview]
Sponsor Name for Cefazolin In Plastic Container
Sponsor Trials
B. Braun Medical Inc. 4
Population Health Research Institute 4
University of Sao Paulo General Hospital 3
[disabled in preview] 9
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Sponsor Type

88.3%8.1%0020406080100120140160180200220OtherIndustryNIH[disabled in preview]
Sponsor Type for Cefazolin In Plastic Container
Sponsor Trials
Other 218
Industry 20
NIH 7
[disabled in preview] 2
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Cefazolin In Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction to Cefazolin

Cefazolin 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 administered post-surgery to prevent infections.

Clinical Trials Update

Tourniquet Use and Local Tissue Concentrations

A recent prospective randomized clinical trial published in JAMA Network Open investigated the 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 significantly reduced the mean concentrations of cefazolin in fat, synovium, and bone tissues by 60 minutes after infusion. The concentrations were insufficient to cover pathogens with elevated minimum inhibitory concentrations (MICs).
  • Methodology: The trial involved 59 adults undergoing TKA, with samples of fat, synovium, and bone collected at various time points. The concentrations were measured using liquid chromatography–tandem mass spectrometry (LC-MS).
  • Implications: The findings suggest that tourniquet use may compromise the effectiveness of cefazolin against certain pathogens, highlighting the need for careful consideration in surgical procedures.

Market Analysis

Global Market Trends

The global cefazolin sodium market is expected to grow at a significant Compound Annual Growth Rate (CAGR) of 5.9% during the forecast period from 2022 to 2028[2][5].

  • Driving Factors: The growth is driven by the increasing prevalence of infectious diseases globally, the use of cefazolin in penicillin-allergic patients, and its application in preventing infections post-surgery.
  • Regional Outlook: The Asia-Pacific region is anticipated to hold the major share in the global cefazolin sodium market, fueled by research and development activities in the healthcare sector and the presence of key market players such as CSPC Pharmaceutical Group Ltd. and LKPC Pharmaceutical Co. Ltd.[2].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the cefazolin sodium market. While there was a shortfall in raw materials due to trade restrictions, the demand for cefazolin increased as it was used in intensive care units to treat COVID-19 patients. This imbalance between supply and demand affected the market dynamics[2].

Market Segmentation

  • End-Users: Adults are the major end-users of cefazolin sodium globally, due to their higher susceptibility to various infections[2].
  • Applications: Cefazolin is used in treating a wide range of bacterial infections, including respiratory tract, genital, and urinary tract infections, as well as in preventing infections post-surgery[3].

Market Projections

Growth Prospects

The global cefazolin sodium market is expected to continue growing, driven by several factors:

  • Increasing Infectious Diseases: The rising prevalence of infectious diseases globally is a significant driver of market growth[2].
  • Research and Development: Ongoing research to develop new antimicrobial drugs that can combat antibiotic-resistant bacteria is expected to fuel the market. For example, research at Dartmouth and Oxford University aims to develop treatments that can reverse antibiotic resistance[5].
  • Government Initiatives: Government initiatives in countries like India, such as the Soft Loan for Pharma Industrial R&D Projects, are supporting the development of new drugs and boosting market growth[2].

New Product Developments

B. Braun Medical Inc. recently received FDA approval for a 2-g Cefazolin for Injection USP in their DUPLEX Drug Delivery System. This innovation provides a ready-to-use, two-compartment flexible plastic IV container that stores pre-measured drug and diluent doses, enhancing the safety, convenience, and accuracy of cefazolin administration[4].

Competitive Landscape

The global cefazolin sodium market is competitive, with several key players contributing to its growth:

  • Major Companies: CSPC Pharmaceutical Group Ltd., Dun& Bradstreet, Inc., HISUN USA Ltd., Pfizer Inc., and LKPC Pharmaceutical Co. Ltd. are among the major companies in the market. These companies are adopting strategies such as mergers and acquisitions, collaborations, and new product launches to stay competitive[2].

Conclusion

Cefazolin remains a crucial antibiotic in the treatment and prevention of bacterial infections. The recent clinical trial highlighting the impact of tourniquet use on cefazolin concentrations in local tissues underscores the need for careful clinical practice. The market for cefazolin sodium is poised for significant growth, driven by increasing infectious diseases, research and development, and innovative product deliveries.

Key Takeaways

  • Clinical Trials: Tourniquet use can significantly reduce cefazolin concentrations in local tissues during surgery.
  • Market Growth: The global cefazolin sodium market is expected to grow at a CAGR of 5.9% from 2022 to 2028.
  • Regional Dominance: The Asia-Pacific region is anticipated to hold the major share in the global market.
  • New Developments: FDA-approved 2-g Cefazolin in the DUPLEX Drug Delivery System enhances administration safety and convenience.
  • Competitive Landscape: Major pharmaceutical companies are driving market growth through various strategies.

FAQs

What is the primary use of cefazolin?

Cefazolin is primarily used to treat various bacterial infections, including those of the skin, bones, joints, genital, respiratory, and urinary tracts, as well as to prevent infections post-surgery.

How does tourniquet use affect cefazolin concentrations in local tissues?

Tourniquet use significantly reduces the mean concentrations of cefazolin in fat, synovium, and bone tissues, potentially compromising its effectiveness against certain pathogens.

What is the expected growth rate of the global cefazolin sodium market?

The global cefazolin sodium market is expected to grow at a CAGR of 5.9% during the forecast period from 2022 to 2028.

Which region is anticipated to dominate the global cefazolin sodium market?

The Asia-Pacific region is anticipated to hold the major share in the global cefazolin sodium market.

What is the significance of B. Braun's FDA-approved 2-g Cefazolin?

B. Braun's FDA-approved 2-g Cefazolin in the DUPLEX Drug Delivery System provides a ready-to-use, safe, and convenient method for administering cefazolin, enhancing patient safety and outcomes.

Sources

  1. JAMA Network Open: "Tourniquet Use and Local Tissue Concentrations of Cefazolin During Total Knee Arthroplasty: A Prospective Randomized Clinical Trial."
  2. OMR Global: "Cefazolin Sodium Market Trends, Share, Global Industry Report and Forecast 2022-2028."
  3. FDA: "Cefazolin Injection - accessdata.fda.gov."
  4. Drug Development: "B. Braun Becomes First to Deliver FDA-Approved 2-g Cefazolin."
  5. OMR Global: "Cefazolin Market Size, Comprehensive Analysis & Forecast to 2028."

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