Heart BlockPhase 4BI-PACEDNCT06448624
Biomarkers & Infection After Prophylactic Antibiotic in Cardiac Implantable Electronic Device Implantation
A Phase 4 study testing Ampicillin sulbactam 3 days in people with Heart Block and CIED Related Infection, run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
Effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Block, CIED Related Infection, CIED-related Infections
- What is being tested?
- Ampicillin sulbactam 3 days
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2024to 31 Jan 2025
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indication of CIED implantation
- No infection at the time of implantation
Who cannot join
- Refuse to participate in the study
- Allergy to ampicillin sulbactam
- CIED debridement
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Kariadi Central General Hospital
Semarang, Central Java, 50244
About this study
Official title: Effect of Single Dose & Intrapocket Prophylactic Antibiotic to Cardiac Implantable Electronic Device-related Infection & Biomarkers
Effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers
- Conditions
- Heart Block, CIED Related Infection, CIED-related Infections, Antibiotic Prophylaxis, Biomarkers
- Being tested
- Ampicillin sulbactam 3 days, Placebo 3 days
- Keywords
- heart block, CIED related infection, antibiotic prophylaxis, biomarkers
- Medical subject headings
- Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ampicillin sulbactam 3 daysDrug
Ampicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation
Placebo 3 daysDrug
Placebo for 3 days after CIED implantation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Placebo comparator | Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation Receives: Drug: Placebo 3 days |
| Control | Experimental | Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + ampicillin sulbactam 1.5 gram IV BID for 3 days after implantation Receives: Drug: Ampicillin sulbactam 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CIED-related infection
Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization
Measured: Baseline, 3 days, 7 days, and 28 days
Secondary outcomes (3)
Level of Presepsin
Delta level of Presepsin
Measured: Baseline and 24 hours after CIED implantation
Level of Interleukin-6
Delta level of Interleukin-6
Measured: Baseline and 24 hours after CIED implantation
Level of Procalcitonin
Delta level of Procalcitonin
Measured: Baseline and 24 hours after CIED implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Apr 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart BlockStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Kariadi General Hospital Medical Center
- Responsible party
- Principal investigator, Pipin Ardhianto, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448624
- Sponsor's protocol ID
- No.16114/EC/KEPK-RSDK/2024
- Acronym
- BI-PACED
- Status last verified
- Feb 2025
- First submitted
- 28 May 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Waiting for agreement
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Dose & Intrapocket Prophylactic Antibiotic to Cardiac Implantable Electronic Device-related Infection & Biomarkers
- ClinicalTrials.gov ID
- NCT06448624
- Acronym / sponsor ID
- BI-PACED / No.16114/EC/KEPK-RSDK/2024
- Conditions
- Heart Block, CIED Related Infection, CIED-related Infections, Antibiotic Prophylaxis, Biomarkers
- Keywords
- heart block, CIED related infection, antibiotic prophylaxis, biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Collaborators
- Dr. Kariadi General Hospital Medical Center
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 7 Jun 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.
Effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Placebo comparator | Drug: Placebo 3 daysAmpicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation |
| Control | Experimental | Drug: Ampicillin sulbactam 3 daysAmpicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + ampicillin sulbactam 1.5 gram IV BID for 3 days after implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Indication of CIED implantation
- No infection at the time of implantation
Key exclusion criteria (3 listed)
- Refuse to participate in the study
- Allergy to ampicillin sulbactam
- CIED debridement
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 |
|---|---|---|
| Ampicillin sulbactam 3 daysAmpicillin sulbactam 1.5 gram IV BID for 3 days after CIED implantation | Drug | Control |
| Placebo 3 daysPlacebo for 3 days after CIED implantation | Drug | Intervention |
Primary outcome
Incidence of CIED-related infection
Time frame: Baseline, 3 days, 7 days, and 28 days
Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization
3 secondary outcomes
Level of Presepsin
Time frame: Baseline and 24 hours after CIED implantation
Level of Interleukin-6
Time frame: Baseline and 24 hours after CIED implantation
Level of Procalcitonin
Time frame: Baseline and 24 hours after CIED implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided. Waiting for agreement
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ampicillin sulbactam 3 days in people with Heart Block and CIED Related Infection, run by Universitas Diponegoro 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 27 Feb 2025. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CIED-related infection (time frame: Baseline, 3 days, 7 days, and 28 days). 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 27 Feb 2025.