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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR CEFOTIAM HYDROCHLORIDE


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All Clinical Trials for Cefotiam Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02693951 ↗ Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices Unknown status Shanghai Zhongshan Hospital N/A 2016-02-01 The purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.
NCT04209192 ↗ Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB) Recruiting Laboratorios Senosiain, S.A. de C.V. Phase 2 2020-01-01 Antimicrobial prophylaxis in urological procedures is aimed to reduce the risk of local and systemic postoperative infections such as urinary tract infection or surgical site infection. It should be recommended only when the potential benefit exceeds the anticipated risks and costs. However, a wide variation in the use of periprocedural prophylactic antibiotics has been demonstrated, which frequently is incurred as an inappropriate selection of antimicrobials, inadequate schedule of administration or excessive duration of prophylaxis. The increase in multidrug resistance of antibiotics in recent decades has been associated with its misuse, resulting in an increased rate of morbidity and mortality, prolonged hospital stays and increased care costs. Specifically, resistance to fluoroquinolones has increased its prevalence, a group of antibiotics widely used in urology. Therefore, local resistance patterns should be considered before following recommendations, especially in populations with poor control of antimicrobial use. Transurethral resection of bladder (TURB) has become a frequent surgical procedure, as it is the main diagnostic and therapeutic tool for bladder cancer, representing the ninth most common malignancy in the world. However, no recent randomized clinical trial has investigated antimicrobial prophylaxis for TURB. It is well known that an expected complication of TURB is urinary tract infection (UTI), which is the most common healthcare related infection worldwide. Under this premise, a randomized clinical trial is proposed to analyze the current panorama of UTI as a transcendent postoperative complication of TURB, under the context of the new emerging resistance parameters. The use of fosfomycin trometamol is proposed as a good potential option for urological procedures due to its high activity against multidrug-resistant gram-negative bacteria and its favorable pharmacokinetic parameters that guarantees wide tissue penetration and a high urinary concentration, in a single dose, the which will be compared with the control group with traditional prophylaxis (amikacin). The relative risk of UTI will be estimated, as well as the attributable risk of the main risk factors associated with this infection, allowing a better characterization of this population for adequate decision making regarding this clinical challenge.
NCT04209192 ↗ Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB) Recruiting Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Phase 2 2020-01-01 Antimicrobial prophylaxis in urological procedures is aimed to reduce the risk of local and systemic postoperative infections such as urinary tract infection or surgical site infection. It should be recommended only when the potential benefit exceeds the anticipated risks and costs. However, a wide variation in the use of periprocedural prophylactic antibiotics has been demonstrated, which frequently is incurred as an inappropriate selection of antimicrobials, inadequate schedule of administration or excessive duration of prophylaxis. The increase in multidrug resistance of antibiotics in recent decades has been associated with its misuse, resulting in an increased rate of morbidity and mortality, prolonged hospital stays and increased care costs. Specifically, resistance to fluoroquinolones has increased its prevalence, a group of antibiotics widely used in urology. Therefore, local resistance patterns should be considered before following recommendations, especially in populations with poor control of antimicrobial use. Transurethral resection of bladder (TURB) has become a frequent surgical procedure, as it is the main diagnostic and therapeutic tool for bladder cancer, representing the ninth most common malignancy in the world. However, no recent randomized clinical trial has investigated antimicrobial prophylaxis for TURB. It is well known that an expected complication of TURB is urinary tract infection (UTI), which is the most common healthcare related infection worldwide. Under this premise, a randomized clinical trial is proposed to analyze the current panorama of UTI as a transcendent postoperative complication of TURB, under the context of the new emerging resistance parameters. The use of fosfomycin trometamol is proposed as a good potential option for urological procedures due to its high activity against multidrug-resistant gram-negative bacteria and its favorable pharmacokinetic parameters that guarantees wide tissue penetration and a high urinary concentration, in a single dose, the which will be compared with the control group with traditional prophylaxis (amikacin). The relative risk of UTI will be estimated, as well as the attributable risk of the main risk factors associated with this infection, allowing a better characterization of this population for adequate decision making regarding this clinical challenge.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cefotiam Hydrochloride

Condition Name

Condition Name for Cefotiam Hydrochloride
Intervention Trials
Urologic Surgical Procedures 1
Bladder Cancer 1
Cirrhosis 1
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Condition MeSH

Condition MeSH for Cefotiam Hydrochloride
Intervention Trials
Esophageal and Gastric Varices 1
Urinary Tract Infections 1
Varicose Veins 1
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Clinical Trial Locations for Cefotiam Hydrochloride

Trials by Country

Trials by Country for Cefotiam Hydrochloride
Location Trials
China 1
Mexico 1
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Clinical Trial Progress for Cefotiam Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Cefotiam Hydrochloride
Clinical Trial Phase Trials
Phase 2 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for Cefotiam Hydrochloride
Clinical Trial Phase Trials
Recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Cefotiam Hydrochloride

Sponsor Name

Sponsor Name for Cefotiam Hydrochloride
Sponsor Trials
Shanghai Zhongshan Hospital 1
Laboratorios Senosiain, S.A. de C.V. 1
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 1
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Sponsor Type

Sponsor Type for Cefotiam Hydrochloride
Sponsor Trials
Other 2
Industry 1
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