Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03587337
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2018-02-19
Brief Title:
Risk of Microbial Translocation in Patients Undergoing Per-Oral Endoscopic Myotomy POEM for Achalasia Antibiotic Prophylaxis or Short-therapy
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Risk of Microbial Translocation in Patients Undergoing Per-Oral Endoscopic Myotomy POEM for Achalasia Antibiotic Prophylaxis or Short-therapy
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POEM-MT01
Brief Summary:
Background Achalasia is a primary rare esophageal motor disorder of the esophagus annual incidence of 1100000 persons Recently a new endoscopic technique Per-Oral Endoscopic Myotomy POEM has been introduced with excellent success rates Several studies have evaluated complications of POEM but there is a lack of knowledge on the potential risk of bacteremia or microbial translocation during the endoscopic intervention and also there arent evidences regarding the use of antibiotics beforeafter POEM Microbial translocation MT is the passage of both viable and nonviable microbes across the anatomically intact GI barrier to the mesenteric lymph nodes and possibly other tissues Gram-negative bacteria contain lipopolysaccharides LPSs coating their thin peptidoglycan cell wall The presence of LPS an endotoxin in the plasma has been correlated to sepsis and septic shock through the activation of the inflammatory host defence via binding to soluble CD14 sCD14 which initiates downstream cytokines like IL-6 IL-8 and tumor necrosis factor TNF-α and also through the production of sCD14 and LPS-binding protein LBP by the innate immune system
Objectives Considering POEM a clean-contaminated procedure it should be assessed whether the post-POEM fever or systemic inflammation is a cytokinin-mediated or an infection-related fever Thus aim of the study is to evaluate the presence of inflammation mediators bacteremia and microbial translocation post POEM to guide future antibiotic prophylaxistherapy in patients undergoing this procedure
Methods All patients who will undergo POEM at _Investigators Department from June 2017 to June 2019 will be enrolled in a prospective interventional randomized clinical trial RCT Patients will be randomized in two groups The Group A prophylaxis group will receive antibiotics Cefazolin 2 gr iv only before procedure whereas Group B short therapy group will receive antibiotics before POEM Cefazolin 2 gr iv continued for the first 24 hours and then per os AmoxicillineClavulanic Acid 3 grdie for 3 days For each patient we will be evaluated dosage of IL-6 IL-1β TNF-α sCD4 LPB LPS and blood cultures
Expected results we expect that the prophylaxis group vs short therapy group has a prevalence of fever andor systemic inflammation not higher than 10 difference of the fever related to the procedure
Objectives Considering POEM a clean-contaminated procedure it should be assessed whether the post-POEM fever or systemic inflammation is a cytokinin-mediated or an infection-related fever Thus aim of the study is to evaluate the presence of inflammation mediators bacteremia and microbial translocation post POEM to guide future antibiotic prophylaxistherapy in patients undergoing this procedure
Methods All patients who will undergo POEM at _Investigators Department from June 2017 to June 2019 will be enrolled in a prospective interventional randomized clinical trial RCT Patients will be randomized in two groups The Group A prophylaxis group will receive antibiotics Cefazolin 2 gr iv only before procedure whereas Group B short therapy group will receive antibiotics before POEM Cefazolin 2 gr iv continued for the first 24 hours and then per os AmoxicillineClavulanic Acid 3 grdie for 3 days For each patient we will be evaluated dosage of IL-6 IL-1β TNF-α sCD4 LPB LPS and blood cultures
Expected results we expect that the prophylaxis group vs short therapy group has a prevalence of fever andor systemic inflammation not higher than 10 difference of the fever related to the procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None