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Last Updated: January 27, 2023

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.
NCT01220661 ↗ Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery Completed National Cancer Center, Korea Phase 2 2010-10-01 In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses. It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough. The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
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.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of 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.
NCT02099240 ↗ Patients Response to Early Switch To Oral:Osteomyelitis Study Terminated James Graham Brown Cancer Center Early Phase 1 2014-03-06 Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefotetan

Condition Name

Condition Name for Cefotetan
Intervention Trials
Colorectal Surgery 2
Atrial Fibrillation 1
Cholecystitis 1
Osteomyelitis 1
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Condition MeSH

Condition MeSH for Cefotetan
Intervention Trials
Surgical Wound Infection 1
Cholecystitis 1
Osteomyelitis 1
Atrial Fibrillation 1
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Clinical Trial Locations for Cefotetan

Trials by Country

Trials by Country for Cefotetan
Location Trials
United States 2
Brazil 1
Korea, Republic of 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
[disabled in preview] 3
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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
Merck Sharp & Dohme Corp. 1
Santa Clara Valley Health & Hospital System 1
Stanford University 1
[disabled in preview] 4
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Sponsor Type

Sponsor Type for Cefotetan
Sponsor Trials
Other 9
Industry 1
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Serving leading biopharmaceutical companies globally:

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AstraZeneca
McKinsey

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