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Last Updated: January 17, 2025

CLINICAL TRIALS PROFILE FOR CEFOTETAN


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505(b)(2) Clinical Trials for Cefotetan

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT00090272 ↗ A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039) Completed Merck Sharp & Dohme Corp. Phase 3 2002-04-01 The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cefotetan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00090272 ↗ A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039) Completed Merck Sharp & Dohme Corp. Phase 3 2002-04-01 The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.
NCT00186082 ↗ Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs Completed Santa Clara Valley Health & Hospital System N/A 2003-09-01 This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
NCT00186082 ↗ Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs Completed Stanford University N/A 2003-09-01 This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefotetan

Condition Name

Condition Name for Cefotetan
Intervention Trials
Colorectal Surgery 2
Pregnancy Complications, Infectious 1
Atrial Fibrillation 1
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Condition MeSH

Condition MeSH for Cefotetan
Intervention Trials
Atrial Fibrillation 1
Pregnancy Complications, Infectious 1
Pregnancy Complications 1
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Clinical Trial Locations for Cefotetan

Trials by Country

Trials by Country for Cefotetan
Location Trials
United States 2
Korea, Republic of 1
Brazil 1
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Trials by US State

Trials by US State for Cefotetan
Location Trials
Kentucky 1
California 1
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Clinical Trial Progress for Cefotetan

Clinical Trial Phase

Clinical Trial Phase for Cefotetan
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Cefotetan
Clinical Trial Phase Trials
Completed 5
Terminated 1
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Clinical Trial Sponsors for Cefotetan

Sponsor Name

Sponsor Name for Cefotetan
Sponsor Trials
Federal University of São Paulo 1
James Graham Brown Cancer Center 1
University of Louisville 1
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Sponsor Type

Sponsor Type for Cefotetan
Sponsor Trials
Other 9
Industry 1
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Clinical Trials, Market Analysis, and Projections for Cefotetan

Introduction to Cefotetan

Cefotetan is a second-generation cephalosporin antibiotic, widely used for its broad-spectrum antibacterial activity. It is particularly effective against gram-negative bacteria and is often employed in surgical prophylaxis and the treatment of various infections.

Clinical Efficacy and Safety

Surgical Prophylaxis

In clinical trials, cefotetan has demonstrated efficacy in reducing postoperative wound infections. A multicenter trial comparing a single 2 g preoperative dose of cefotetan with multiple doses of cefoxitin in colorectal surgery showed that cefotetan was as safe and effective as cefoxitin. The study involved 289 patients, with no statistically significant difference in clinical response rates between the two groups (88% for cefotetan and 92% for cefoxitin)[1].

Treatment of Infections

Cefotetan has also been evaluated in the treatment of obstetric and gynecologic infections. In two multicenter clinical trials, cefotetan was compared with moxalactam and cefoxitin. The results indicated high clinical response rates for cefotetan, with 96% and 94% success rates in the respective studies. Cefotetan was well tolerated, with no major adverse reactions reported[3].

Dosage and Administration

Adult Prophylaxis

For preventing postoperative infections, the recommended dosage is 1 or 2 g of cefotetan administered intravenously 30 to 60 minutes prior to surgery. In cesarean sections, the dose should be given as soon as the umbilical cord is clamped[4].

Patients with Impaired Renal Function

For patients with impaired renal function, a reduced dosage schedule is necessary. The dosing interval may be extended to every 24 or 48 hours, depending on the creatinine clearance levels[4].

Adverse Reactions and Interactions

Cefotetan is generally well tolerated, but it can cause some adverse reactions. Common adverse reactions include diarrhea (1.25%), hypersensitivity reactions (1.2%), and laboratory abnormalities such as hepatic enzyme elevations (1.2%)[4].

Drug/Laboratory Test Interactions

Cefotetan can interfere with certain laboratory tests, such as glucose tests based on Benedict’s copper reduction reaction and creatinine measurements by Jaffé reaction. It is recommended to use enzymatic glucose oxidase tests for glucose measurement[4].

Market Analysis and Projections

Market Size and Growth

The global Cefotetan Disodium API market has experienced significant growth in recent years and is anticipated to continue this trend. The market size was valued at USD billion in 2023 and is forecasted to reach USD billion by 2031, exhibiting a robust growth rate over the forecast period[2].

Segmentation

The market is segmented by type (purity levels of 98%, 99%, and 99.5%), application (antibacterial agent, pharmaceuticals, medical research, and clinical trials), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Key Players

Major players in the Cefotetan Disodium API market include Merck & Co. Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., Cipla Limited, and Sandoz International GmbH (Novartis AG), among others. These companies play a crucial role in driving market growth through their production and distribution capabilities[2].

Market Dynamics

The market is driven by factors such as increasing demand for antibacterial agents, advancements in pharmaceutical research, and the expanding need for effective treatments in various medical fields. However, the market also faces challenges such as the development of drug-resistant bacteria and regulatory hurdles[2].

Regional Market Outlook

North America and Europe

These regions are expected to remain significant markets for Cefotetan Disodium API due to their well-established healthcare systems and high demand for advanced pharmaceuticals.

Asia-Pacific

This region is anticipated to experience rapid growth due to increasing healthcare expenditure, growing populations, and the emergence of new pharmaceutical companies.

Future Outlook

The Cefotetan Disodium API market is poised for continued growth, driven by the increasing global demand for effective antibacterial treatments. As the healthcare sector continues to evolve, the market is expected to benefit from advancements in medical research and the expanding use of cefotetan in various clinical applications.

"The positive momentum in market dynamics, alongside the expected sustained expansion, points to the anticipation of robust growth rates over the forecasted period."[2]

Key Takeaways

  • Clinical Efficacy: Cefotetan is effective in reducing postoperative wound infections and treating various bacterial infections.
  • Safety Profile: Generally well tolerated, with common adverse reactions including diarrhea and hypersensitivity reactions.
  • Market Growth: The global Cefotetan Disodium API market is expected to grow significantly from 2023 to 2031.
  • Segmentation: Market segmented by type, application, and geographical regions.
  • Key Players: Major pharmaceutical companies drive market growth through production and distribution.

FAQs

What is the recommended dosage of cefotetan for surgical prophylaxis?

The recommended dosage is 1 or 2 g of cefotetan administered intravenously 30 to 60 minutes prior to surgery[4].

How does cefotetan compare with other antibiotics in clinical trials?

Cefotetan has been shown to be as effective as cefoxitin and moxalactam in various clinical trials, with high clinical response rates and a favorable safety profile[1][3].

What are the common adverse reactions associated with cefotetan?

Common adverse reactions include diarrhea, hypersensitivity reactions, and laboratory abnormalities such as hepatic enzyme elevations[4].

What is the projected growth of the Cefotetan Disodium API market?

The market is expected to grow significantly from 2023 to 2031, driven by increasing demand for antibacterial agents and advancements in pharmaceutical research[2].

Which regions are expected to drive the growth of the Cefotetan Disodium API market?

North America, Europe, and the Asia-Pacific region are expected to be key drivers of market growth due to their healthcare infrastructure and growing demand for pharmaceuticals[2].

Sources

  1. Single-dose cefotetan versus multiple-dose cefoxitin as prophylaxis... - PubMed
  2. Cefotetan Disodium API Market Size, Scope And Forecast Report - Market Research Intellect
  3. Multicenter clinical trials comparing cefotetan with moxalactam or... - PubMed
  4. CEFOTETAN for injection AND DEXTROSE... - FDA
  5. Global Cefotetan Disodium API Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030 - Market Research Reports

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