Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355115
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-12-19
Brief Title:
Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker PPM Installation
Sponsor:
University of Brawijaya
Organization:
University of Brawijaya
Study Overview
Official Title:
Comparison Effect Between a Single Dose Prophylaxis Antibiotics Given One Day and Three Days Towards Healing and Risk of Infection in Permanent Pacemaker PPM Installation a Preliminary Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
PACE-PRO
Brief Summary:
The insertion of a permanent pacemaker PPM is frequently a life-saving procedure However the implantation process could sometimes lead to a rare but serious infection Therefore administering prophylactic antibiotics to prevent infections before they occur is a useful strategy to lower the risk of such infections
Nonetheless the optimal duration of prophylactic antibiotics for PPM remains uncertain Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use Accordingly the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations
The main questions it aims to answer are
1 What is the efficacy of different durations of prophylactic antibiotics single dosage vs 3-day dosage in preventing infective complications following PPM implantations
2 What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications
Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections
Participants will
Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations
Visit the clinic for follow-ups and tests
Nonetheless the optimal duration of prophylactic antibiotics for PPM remains uncertain Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use Accordingly the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations
The main questions it aims to answer are
1 What is the efficacy of different durations of prophylactic antibiotics single dosage vs 3-day dosage in preventing infective complications following PPM implantations
2 What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications
Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections
Participants will
Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations
Visit the clinic for follow-ups and tests
Detailed Description:
The insertion of a permanent pacemaker PPM is a critical intervention often performed to manage various cardiac rhythm disorders thereby enhancing patient survival and quality of life However the procedure carries a risk of introducing infections which although infrequent can lead to severe complications Prophylactic administration of antibiotics has been recognized as an effective measure to mitigate this risk by preventing the onset of infections prior to their occurrence
Despite the widespread acceptance of this practice the optimal duration of antibiotic prophylaxis for PPM implantation remains a subject of debate Variability in clinical protocols across different healthcare centers further complicates the establishment of a standardized approach This clinical trial is designed to address this gap by evaluating and comparing the efficacy of two commonly employed prophylactic antibiotic regimens - a single dose versus a three-day course - in reducing the incidence of infectious complications following PPM implantations
The study aims to address the following research questions
1 What is the comparative effectiveness of a single dose versus a three-day course of prophylactic antibiotics in preventing infectious complications after PPM implantation
2 What patient-specific or procedural factors might influence the optimal choice and duration of prophylactic antibiotic therapy in the context of PPM implantation
To achieve these objectives the trial will enroll patients scheduled for PPM implantation and randomly assign them to receive either a single dose or a three-day course of antibiotics The choice of antibiotic will be based on our institutional guidelines ie 1 gram of intravenous Cefazolin first-generation cephalosporins and by considering the patients allergy history The primary outcome will be the occurrence of device-related infections within a specified follow-up period assessed through clinical examinations laboratory tests and imaging studies
Participants will be required to attend follow-up visits at designated intervals post-implantation for assessment of any signs of infection wound healing and device function Adherence to the antibiotic regimen and any adverse reactions will also be monitored
By systematically comparing the outcomes of the two antibiotic regimens this study aims to provide evidence-based guidance for the optimization of prophylactic antibiotic use in PPM implantations thereby enhancing patient safety and treatment efficacy
Despite the widespread acceptance of this practice the optimal duration of antibiotic prophylaxis for PPM implantation remains a subject of debate Variability in clinical protocols across different healthcare centers further complicates the establishment of a standardized approach This clinical trial is designed to address this gap by evaluating and comparing the efficacy of two commonly employed prophylactic antibiotic regimens - a single dose versus a three-day course - in reducing the incidence of infectious complications following PPM implantations
The study aims to address the following research questions
1 What is the comparative effectiveness of a single dose versus a three-day course of prophylactic antibiotics in preventing infectious complications after PPM implantation
2 What patient-specific or procedural factors might influence the optimal choice and duration of prophylactic antibiotic therapy in the context of PPM implantation
To achieve these objectives the trial will enroll patients scheduled for PPM implantation and randomly assign them to receive either a single dose or a three-day course of antibiotics The choice of antibiotic will be based on our institutional guidelines ie 1 gram of intravenous Cefazolin first-generation cephalosporins and by considering the patients allergy history The primary outcome will be the occurrence of device-related infections within a specified follow-up period assessed through clinical examinations laboratory tests and imaging studies
Participants will be required to attend follow-up visits at designated intervals post-implantation for assessment of any signs of infection wound healing and device function Adherence to the antibiotic regimen and any adverse reactions will also be monitored
By systematically comparing the outcomes of the two antibiotic regimens this study aims to provide evidence-based guidance for the optimization of prophylactic antibiotic use in PPM implantations thereby enhancing patient safety and treatment efficacy
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?:
False
Is an FDA AA801 Violation?:
None