Pacemaker ComplicationPhase 2PACE-PRONCT06355115
Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation
A Phase 2 study testing Cefazolin 1000 MG Injection in people with Pacemaker Complication, run by University of Brawijaya at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pacemaker Complication
- What is being tested?
- Cefazolin 1000 MG Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2023to 1 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Case inclusion criteria
- Adult patients, aged 18 to 100 years old, with indications for PPM (single or double chamber) installation.
- The patient is scheduled to undergo PPM installation for the first time
- The patient is willing to undergo routine follow-ups and visits
- Patients who are medically stable and do not have any acute illnesses that could interfere with the study outcomes.
Who cannot join
- Patients with fever before the Procedure
- Skin disease
- Patients on anticoagulants or receiving bridging heparin
- Patients who used antibiotics 30 days before the PPM installation was carried out
- Patients with end stage renal failure
- Patients with uncontrolled Diabetes Mellitus
Show all 14Show fewer
- Patients with a history of infective endocarditis
- Patients with a history of moderate to severe valvular heart disease
- Patients with congenital heart disease
- Patients with non-cardiac comorbid diseases whose life expectancy is < 1 year
- Illness or physical disorder that causes the patient to be unable or limited to carry out physical activities
- Patients with a history of autoimmune disease, and confirmed autoimmune disease
- Patients on long-term steroid use
- The patient refused follow-up
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUD Dr. Saiful Anwar
Malang, East Java, 65112
RSUD Dr. Saiful Anwar, 0341-362101, staf-rsu-drsaifulanwar@jatimprov.go.id
About this study
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
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.
Read more
The main questions it aims to answer are:
- What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations?
- 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.
Read the 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:
- What is the comparative effectiveness of a single dose versus a three-day course of prophylactic antibiotics in preventing infectious complications after PPM implantation?
- 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, i.e. 1 gram of intravenous Cefazolin (first-generation cephalosporins), and by considering the patient's 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.
- Conditions
- Pacemaker Complication
- Being tested
- Cefazolin 1000 MG Injection
- Keywords
- permanent pacemakers, infections, prophylactic antibiotics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin 1000 MG InjectionDrug
Cefazolin 1000 mg given intravenously
| Study group | Role | What they receive |
|---|---|---|
| Three days dose prophylaxis | Active comparator | Intravenous (iv) injection of Cefazolin 1 gram 1-hour pre-procedure followed by iv injection of Cefazolin 1 gram every 12 hours for 3 days post-procedure (6 doses) Receives: Drug: Cefazolin 1000 MG Injection |
| Single dose prophylaxis | Experimental | Intravenous injection of Cefazolin 1 gram 1-hour pre-procedure Receives: Drug: Cefazolin 1000 MG Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with early pocket infection (EPI)
EPI refers to a post-operative complication characterized by wound infection or infection of the device pouch within the initial weeks or month following surgical procedure. Manifestations of early pocket infections include local signs of inflammation such as erythema, edema, warmth, and tenderness at the implantation site, occasionally accompanied by purulent discharge or systemic symptoms such as fever.
Measured: 0-30 days
Number of participants with late pocket infection (LPI)
LPI refers to a post-operative complication characterized by wound infection or infection of the device pouch within the following months following surgical procedure. Manifestations of late pocket infections are similar to those of EPI, which include local signs of inflammation such as erythema, edema, warmth, and tenderness at the implantation site, occasionally accompanied by purulent discharge or systemic symptoms such as fever.
Measured: 1-3 months
Number of participants with infective endocarditis (IE)
IE following the implantation of PPM is characterized by bacteremia due to device infection, lead vegetation, right infective endocarditis. Diagnosis is established through history taking and physical examination and the visualization of vegetations by Transthoracic Echocardiography (TTE).
Measured: 1 year
Number of participants who underwent pacemaker revision
Pacemaker revision or reimplantation due to infective complications.
Measured: 1 year
Secondary outcomes (6)
Level of C-reactive protein (mg/dl)
C-reactive protein (CRP) levels will be measured from venous blood samples obtained from patients on the third day following the PPM implantation procedure.
Measured: 3 days
Level of procalcitonin (mcg/dl)
Procalcitonin (PCT) levels will be measured from venous blood samples obtained from patients on the third day following the PPM implantation procedure.
Measured: 3 days
Erythrocyte sedimentation rate (ESR) (mm/hour)
Erythrocyte sedimentation rate (ESR) levels will be measured from venous blood samples obtained from patients on the third day following the PPM implantation procedure.
Measured: 3 days
Neutrophil-to-leukocyte ratio (NLR)
Neutrophil-to-leukocyte ratio (NLR) levels will be measured from venous blood samples obtained from patients on the third day following the PPM implantation procedure.
Measured: 3 days
Neutrophil count (cells/mm3)
Neutrophil count levels will be measured from venous blood samples obtained from patients as part of complete blood count testing, on the third day following the PPM implantation procedure.
Measured: 3 days
Leukocyte count (cells/mm3)
Leukocyte (white blood cells) count levels will be measured from venous blood samples obtained from patients as part of complete blood count testing, on the third day following the PPM implantation procedure.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brawijaya
- Sponsor type
- University, hospital or other
- Collaborators
- Saiful Anwar Hospital
- Responsible party
- Principal investigator, Icmi Dian Rochmawati, University of Brawijaya
- Investigators
- Icmi D Rochmawati, M.D., Principal investigator, University of Brawijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355115
- Sponsor's protocol ID
- 400/218/K.3/302/2023
- Acronym
- PACE-PRO
- Status last verified
- Apr 2024
- First submitted
- 19 Dec 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to the collected data will be restricted solely to authorized members of the research team.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06355115
- Acronym / sponsor ID
- PACE-PRO / 400/218/K.3/302/2023
- Conditions
- Pacemaker Complication
- Keywords
- permanent pacemakers, infections, prophylactic antibiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BrawijayaUniversity, hospital or other
- Collaborators
- Saiful Anwar Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations?
- 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:
- What is the comparative effectiveness of a single dose versus a three-day course of prophylactic antibiotics in preventing infectious complications after PPM implantation?
- 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, i.e. 1 gram of intravenous Cefazolin (first-generation cephalosporins), and by considering the patient's 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three days dose prophylaxis | Active comparator | Drug: Cefazolin 1000 MG InjectionIntravenous (iv) injection of Cefazolin 1 gram 1-hour pre-procedure followed by iv injection of Cefazolin 1 gram every 12 hours for 3 days post-procedure (6 doses) |
| Single dose prophylaxis | Experimental | Drug: Cefazolin 1000 MG InjectionIntravenous injection of Cefazolin 1 gram 1-hour pre-procedure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Case inclusion criteria
- Adult patients, aged 18 to 100 years old, with indications for PPM (single or double chamber) installation.
- The patient is scheduled to undergo PPM installation for the first time
- The patient is willing to undergo routine follow-ups and visits
- Patients who are medically stable and do not have any acute illnesses that could interfere with the study outcomes.
Key exclusion criteria (14 listed)
- Patients with fever before the Procedure
- Skin disease
- Patients on anticoagulants or receiving bridging heparin
- Patients who used antibiotics 30 days before the PPM installation was carried out
- Patients with end stage renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefazolin 1000 MG InjectionCefazolin 1000 mg given intravenously | Drug | Single dose prophylaxis, Three days dose prophylaxis |
Primary outcome
Number of participants with early pocket infection (EPI)
Time frame: 0-30 days
EPI refers to a post-operative complication characterized by wound infection or infection of the device pouch within the initial weeks or month following surgical procedure. Manifestations of early pocket infections include local signs of inflammation such as erythema, edema, warmth, and tenderness at the implantation site, occasionally accompanied by purulent discharge or systemic symptoms such as fever.
Number of participants with late pocket infection (LPI)
Time frame: 1-3 months
LPI refers to a post-operative complication characterized by wound infection or infection of the device pouch within the following months following surgical procedure. Manifestations of late pocket infections are similar to those of EPI, which include local signs of inflammation such as erythema, edema, warmth, and tenderness at the implantation site, occasionally accompanied by purulent discharge or systemic symptoms such as fever.
Number of participants with infective endocarditis (IE)
Time frame: 1 year
IE following the implantation of PPM is characterized by bacteremia due to device infection, lead vegetation, right infective endocarditis. Diagnosis is established through history taking and physical examination and the visualization of vegetations by Transthoracic Echocardiography (TTE).
Number of participants who underwent pacemaker revision
Time frame: 1 year
Pacemaker revision or reimplantation due to infective complications.
6 secondary outcomes
Level of C-reactive protein (mg/dl)
Time frame: 3 days
Level of procalcitonin (mcg/dl)
Time frame: 3 days
Erythrocyte sedimentation rate (ESR) (mm/hour)
Time frame: 3 days
Neutrophil-to-leukocyte ratio (NLR)
Time frame: 3 days
Neutrophil count (cells/mm3)
Time frame: 3 days
Leukocyte count (cells/mm3)
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No. Access to the collected data will be restricted solely to authorized members of the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Icmi D Rochmawati, M.D. principal investigator
University of Brawijaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefazolin 1000 MG Injection in people with Pacemaker Complication, run by University of Brawijaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Icmi D Rochmawati, M.D. (+62 857-6822-8899, icmidianr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with early pocket infection (EPI) (time frame: 0-30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.