Infection, BacterialPhase 4NCT03148444
Impact of Antibiotic Treatment Following Implantation of Cardiac Electronic Device on Patient's Outcome
A Phase 4 study testing cefalexin 500 mg qid or roxithromycin 150 mg bid in people with Infection, Bacterial and Pacemaker Complication, run by Kaplan Medical Center.
Trial summary
Background: Infection of cardiac implantable electronic device including wound and pouch infection, bacteraemia and endocarditis is a common complication of device insertion. The role of antibiotic prophylaxis in prevention of this complication is well established. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Infection, Bacterial, Pacemaker Complication
- What is being tested?
- cefalexin 500 mg qid or roxithromycin 150 mg bid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jun 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution.
Who cannot join
- procedure during which, according to the opinion of the operator, the risk of the contamination would be unusually high (for ex. due to prolonged duration) so that obligatory post-operative use of antibiotics should be warranted,
- patients with any immunosuppressive condition (including cytotoxic chemotherapy, chronic use of glucocorticoids, however excluding diabetes mellitus, renal failure and heart failure);
- malignancy,
- pregnancy and breastfeeding;
- hepatic cirrhosis;
- end stage renal disease (GFR<10 mL/min);
- known allergy to both antibiotic medications used in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Background: Infection of cardiac implantable electronic device including wound and pouch infection, bacteraemia and endocarditis is a common complication of device insertion. The role of antibiotic prophylaxis in prevention of this complication is well established. Most centres in Israel currently prescribe antibiotics about 5 days following the procedure as well, though clear clinical evidence warranting this practise is lacking. Unnecessary antibiotic treatment can lead to adverse events including allergy, undesirable effects of the antibiotics, establishment of resistance to antibiotics among bacteria and further infections with resistant strains.
Objective: The investigators hope to either establish evidence warranting use of post-procedural antibiotic treatment or refuting it.
Methods: The investigators intend to recruit about 400 patients a year into both trial group and control group. The trial group will be treated with post-procedural antibiotics during 5 days, while the control group will receive no post-procedural antibiotics. The endpoints of the study will include infections related to the implantable device and proposed adverse effects of the antibiotics. The t-test will be performed in order to evaluate whether benefit exists concerning one of the groups.
Read the detailed description
The infection of cardiac implantable electronic device site (including both pocket infection and deeper infections) is a common complication of electronic device insertion. Its incidence is estimated in different series as 0.2-0.7 per 100 device-years. The risk factors that raise the incidence of this complication are in the first place lack of or inappropriate antibiotic prophylaxis and repeated or recurrent manipulations with the device. Several comorbidities such as diabetes, renal insufficiency, heart failure, malignancy, anticoagulation treatment, and, non-surprisingly glucocorticoid treatment are the remaining risk factors for the infection. It is worth mentioning that over half of all cases of infection occur during the first year past implantation.
About 75% of all device infections are caused by staphylococci (both S. aureus and coagulase negative staphylococci). The other causative organisms are streptococci, Corynebacterium species, Propionibacterium, gram-negative bacilli and fungi. Main source of infection appears to be pocket contamination by skin flora. In one study the swab specimens obtained from device pockets during the procedure rendered positive culture for coagulase-negative staphylococci in up to one half of the specimens even despite observant aseptic technique and appropriate antibiotic prophylaxis.Thus, the contamination leading to infection of the implantation site can occur during the procedure. Other possible paths for infection include erosion of the device or its leads through the skin and seeding of the device and its leads by systemic bacteremia. The treatment of this complication usually requires explantation of the infected device, intravenous antibiotic treatment and then implantation of a new device through the non-infected route.
The principal approach to prevent device infection remain aseptic technique during the procedure and appropriate antibiotic prophylaxis. Different clinical trials showed that pre-treatment of elective patients before the device implantation with anti-staphylococcal penicillins or with first generation cephalosporins results in decrease in rate of infection with odds ratio about 0.2-0.25.Therefore, current recommendation is to pre-treat patients before implantation of the device with 2-3 gram cefazolin or 1.5 gram cefuroxime, or 15 mg/kg vancomycin or clindamycin 900 mg IV within 4 hours before the procedure. Currently there is no evidence regarding adjuvant antibiotic treatment after the implantation. In the face of lack of evidence, several medical centres in Israel either non-uniformly administer different antibiotic regimens following the implantation or refrain from routinely prescribing any antibiotics to the patients following the implantation.
Objective:
The investigators suppose that non-necessary antibiotic treatment entails several adverse outcomes including direct adverse effects of the antibiotics (e.g. allergy, gastrointestinal effects, QT-prolongation), and induction of resistance to antibiotics among the patient's microflora entailing further infections with resistant bacteria (e.g. urinary tract infections, diarrhea). Therefore, an evidence either warranting use of antibiotics following the implantation of implantable electronic device or refuting it should be established.
Medications:
- cefalexin 500 mg qid,
- roxithromycin 150 mg bid Both medications are authorized in Israel for a variety of infections or infection prevention including prevention of implantable cardiac electronic device infection. Both medications are routinely prescribed in medical centres in Israel following implantation of cardiac electronic devices.
- Conditions
- Infection, Bacterial, Pacemaker Complication
- Being tested
- cefalexin 500 mg qid or roxithromycin 150 mg bid
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefalexin 500 mg qid or roxithromycin 150 mg bidDrug
antibiotics treatment for five days following implantation of cardiac device
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics treated | Experimental | Patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution will be discharged home with recommendations to take antibiotic treatment for 5 days following the procedure (cefalexin 500 mg qid, or in the presence of beta-lactam sensitivity roxithromycin 150 mg bid) Receives: Drug: cefalexin 500 mg qid or roxithromycin 150 mg bid |
| without Antibiotics Treatment | No intervention | Patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution will be discharged home with no recommendations regarding antibiotic treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection
operative wound infection or infection of the device pouch
Measured: 1 year
bacteremia and vegetations
bacteremia due to device infection, lead vegetation, right infective endocarditis
Measured: 1 year
re-operation
re-operation due to infective complications
Measured: 1 year
Secondary outcomes (4)
infection unrelated to implantation
any infection (e.g. bacteremia, urinary tract infection, diarrhea) unrelated to the implantable device, whether demanding hospitalization or not
Measured: 1 year
hospitalization
any hospitalization due to non-infective problems related to the implantable device
Measured: 1 year
adverse event of antibiotics
any event related to adverse effect of antibiotics warranting discontinuation of the drug e.g. allergy
Measured: 1 year
death from any cause
death from any cause unrelated to the problems enumerated among primary outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies 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
- We propose to organize a randomized open-label study in which patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) will be randomly assigned to one of the two groups. Patients in one group will be discharged home with recommendations to take antibiotic treatment for 5 days following the procedure (cefalexin 500 mg qid, or in the presence of beta-lactam sensitivity roxythromycin 150 mg bid) while in the other group no recommendations regarding antibiotic treatment will be given. Both groups will receive antibiotic prophylaxis before the procedure according to the current recommendations. In both groups, the aseptic technique during the procedure will be observed, and proper hygienic measures past the implantation will be taken.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshe Swissa, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148444
- Sponsor's protocol ID
- kmc 0038-16
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Uslan DZ, Sohail MR, St Sauver JL, Friedman PA, Hayes DL, Stoner SM, Wilson WR, Steckelberg JM, Baddour LM. Permanent pacemaker and implantable cardioverter defibrillator infection: a population-based study. Arch Intern Med. 2007 Apr 9;167(7):669-75. doi: 10.1001/archinte.167.7.669.
PubMed 17420425Klug D, Balde M, Pavin D, Hidden-Lucet F, Clementy J, Sadoul N, Rey JL, Lande G, Lazarus A, Victor J, Barnay C, Grandbastien B, Kacet S; PEOPLE Study Group. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation. 2007 Sep 18;116(12):1349-55. doi: 10.1161/CIRCULATIONAHA.106.678664. Epub 2007 Aug 27.
PubMed 17724263Smith PN, Vidaillet HJ, Hayes JJ, Wethington PJ, Stahl L, Hull M, Broste SK. Infections with nonthoracotomy implantable cardioverter defibrillators: can these be prevented? Endotak Lead Clinical Investigators. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 1):42-55. doi: 10.1111/j.1540-8159.1998.tb01060.x.
PubMed 9474647Da Costa A, Lelievre H, Kirkorian G, Celard M, Chevalier P, Vandenesch F, Etienne J, Touboul P. Role of the preaxillary flora in pacemaker infections: a prospective study. Circulation. 1998 May 12;97(18):1791-5. doi: 10.1161/01.cir.97.18.1791.
PubMed 9603533Da Costa A, Kirkorian G, Cucherat M, Delahaye F, Chevalier P, Cerisier A, Isaaz K, Touboul P. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation. 1998 May 12;97(18):1796-801. doi: 10.1161/01.cir.97.18.1796.
PubMed 9603534de Oliveira JC, Martinelli M, Nishioka SA, Varejao T, Uipe D, Pedrosa AA, Costa R, D'Avila A, Danik SB. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):29-34. doi: 10.1161/CIRCEP.108.795906. Epub 2009 Feb 10.
PubMed 19808441Sohail MR, Uslan DZ, Khan AH, Friedman PA, Hayes DL, Wilson WR, Steckelberg JM, Stoner S, Baddour LM. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007 May 8;49(18):1851-9. doi: 10.1016/j.jacc.2007.01.072. Epub 2007 Apr 23.
PubMed 17481444Lekkerkerker JC, van Nieuwkoop C, Trines SA, van der Bom JG, Bernards A, van de Velde ET, Bootsma M, Zeppenfeld K, Jukema JW, Borleffs JW, Schalij MJ, van Erven L. Risk factors and time delay associated with cardiac device infections: Leiden device registry. Heart. 2009 May;95(9):715-20. doi: 10.1136/hrt.2008.151985. Epub 2008 Nov 26.
PubMed 19036758
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antibiotic Treatment Following Implantation of Cardiac Electronic Device on Patient's Outcome
- ClinicalTrials.gov ID
- NCT03148444
- Acronym / sponsor ID
- kmc 0038-16
- Conditions
- Infection, Bacterial, Pacemaker Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 11 May 2017 (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.
Background: Infection of cardiac implantable electronic device including wound and pouch infection, bacteraemia and endocarditis is a common complication of device insertion. The role of antibiotic prophylaxis in prevention of this complication is well established. Most centres in Israel currently prescribe antibiotics about 5 days following the procedure as well, though clear clinical evidence warranting this practise is lacking. Unnecessary antibiotic treatment can lead to adverse events including allergy, undesirable effects of the antibiotics, establishment of resistance to antibiotics among bacteria and further infections with resistant strains.
Objective: The investigators hope to either establish evidence warranting use of post-procedural antibiotic treatment or refuting it.
Methods: The investigators intend to recruit about 400 patients a year into both trial group and control group. The trial group will be treated with post-procedural antibiotics during 5 days, while the control group will receive no post-procedural antibiotics. The endpoints of the study will include infections related to the implantable device and proposed adverse effects of the antibiotics. The t-test will be performed in order to evaluate whether benefit exists concerning one of the groups.
Detailed description
The infection of cardiac implantable electronic device site (including both pocket infection and deeper infections) is a common complication of electronic device insertion. Its incidence is estimated in different series as 0.2-0.7 per 100 device-years. The risk factors that raise the incidence of this complication are in the first place lack of or inappropriate antibiotic prophylaxis and repeated or recurrent manipulations with the device. Several comorbidities such as diabetes, renal insufficiency, heart failure, malignancy, anticoagulation treatment, and, non-surprisingly glucocorticoid treatment are the remaining risk factors for the infection. It is worth mentioning that over half of all cases of infection occur during the first year past implantation.
About 75% of all device infections are caused by staphylococci (both S. aureus and coagulase negative staphylococci). The other causative organisms are streptococci, Corynebacterium species, Propionibacterium, gram-negative bacilli and fungi. Main source of infection appears to be pocket contamination by skin flora. In one study the swab specimens obtained from device pockets during the procedure rendered positive culture for coagulase-negative staphylococci in up to one half of the specimens even despite observant aseptic technique and appropriate antibiotic prophylaxis.Thus, the contamination leading to infection of the implantation site can occur during the procedure. Other possible paths for infection include erosion of the device or its leads through the skin and seeding of the device and its leads by systemic bacteremia. The treatment of this complication usually requires explantation of the infected device, intravenous antibiotic treatment and then implantation of a new device through the non-infected route.
The principal approach to prevent device infection remain aseptic technique during the procedure and appropriate antibiotic prophylaxis. Different clinical trials showed that pre-treatment of elective patients before the device implantation with anti-staphylococcal penicillins or with first generation cephalosporins results in decrease in rate of infection with odds ratio about 0.2-0.25.Therefore, current recommendation is to pre-treat patients before implantation of the device with 2-3 gram cefazolin or 1.5 gram cefuroxime, or 15 mg/kg vancomycin or clindamycin 900 mg IV within 4 hours before the procedure. Currently there is no evidence regarding adjuvant antibiotic treatment after the implantation. In the face of lack of evidence, several medical centres in Israel either non-uniformly administer different antibiotic regimens following the implantation or refrain from routinely prescribing any antibiotics to the patients following the implantation.
Objective:
The investigators suppose that non-necessary antibiotic treatment entails several adverse outcomes including direct adverse effects of the antibiotics (e.g. allergy, gastrointestinal effects, QT-prolongation), and induction of resistance to antibiotics among the patient's microflora entailing further infections with resistant bacteria (e.g. urinary tract infections, diarrhea). Therefore, an evidence either warranting use of antibiotics following the implantation of implantable electronic device or refuting it should be established.
Medications:
- cefalexin 500 mg qid,
- roxithromycin 150 mg bid Both medications are authorized in Israel for a variety of infections or infection prevention including prevention of implantable cardiac electronic device infection. Both medications are routinely prescribed in medical centres in Israel following implantation of cardiac electronic devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We propose to organize a randomized open-label study in which patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) will be randomly assigned to one of the two groups. Patients in one group will be discharged home with recommendations to take antibiotic treatment for 5 days following the procedure (cefalexin 500 mg qid, or in the presence of beta-lactam sensitivity roxythromycin 150 mg bid) while in the other group no recommendations regarding antibiotic treatment will be given. Both groups will receive antibiotic prophylaxis before the procedure according to the current recommendations. In both groups, the aseptic technique during the procedure will be observed, and proper hygienic measures past the implantation will be taken.
| Arm | Type | Receives |
|---|---|---|
| Antibiotics treated | Experimental | Drug: cefalexin 500 mg qid or roxithromycin 150 mg bidPatients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution will be discharged home with recommendations to take antibiotic treatment for 5 days following the procedure (cefalexin 500 mg qid, or in the presence of beta-lactam sensitivity roxithromycin 150 mg bid) |
| without Antibiotics Treatment | No intervention | –Patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution will be discharged home with no recommendations regarding antibiotic treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing de novo implantation or replacement of cardiac implantable devices (single-chamber, dual-chamber and biventricular pacemakers and defibrillators) in our institution.
Key exclusion criteria (7 listed)
- procedure during which, according to the opinion of the operator, the risk of the contamination would be unusually high (for ex. due to prolonged duration) so that obligatory post-operative use of antibiotics should be warranted,
- patients with any immunosuppressive condition (including cytotoxic chemotherapy, chronic use of glucocorticoids, however excluding diabetes mellitus, renal failure and heart failure);
- malignancy,
- pregnancy and breastfeeding;
- hepatic cirrhosis;
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 |
|---|---|---|
| cefalexin 500 mg qid or roxithromycin 150 mg bidantibiotics treatment for five days following implantation of cardiac device | Drug | Antibiotics treated |
Primary outcome
wound infection
Time frame: 1 year
operative wound infection or infection of the device pouch
bacteremia and vegetations
Time frame: 1 year
bacteremia due to device infection, lead vegetation, right infective endocarditis
re-operation
Time frame: 1 year
re-operation due to infective complications
4 secondary outcomes
infection unrelated to implantation
Time frame: 1 year
hospitalization
Time frame: 1 year
adverse event of antibiotics
Time frame: 1 year
death from any cause
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Background: PubMed 17420425Uslan DZ, Sohail MR, St Sauver JL, Friedman PA, Hayes DL, Stoner SM, Wilson WR, Steckelberg JM, Baddour LM. Permanent pacemaker and implantable cardioverter defibrillator infection: a population-based study. Arch Intern Med. 2007 Apr 9;167(7):669-75. doi: 10.1001/archinte.167.7.669.
- Background: PubMed 17724263Klug D, Balde M, Pavin D, Hidden-Lucet F, Clementy J, Sadoul N, Rey JL, Lande G, Lazarus A, Victor J, Barnay C, Grandbastien B, Kacet S; PEOPLE Study Group. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation. 2007 Sep 18;116(12):1349-55. doi: 10.1161/CIRCULATIONAHA.106.678664. Epub 2007 Aug 27.
- Background: PubMed 9474647Smith PN, Vidaillet HJ, Hayes JJ, Wethington PJ, Stahl L, Hull M, Broste SK. Infections with nonthoracotomy implantable cardioverter defibrillators: can these be prevented? Endotak Lead Clinical Investigators. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 1):42-55. doi: 10.1111/j.1540-8159.1998.tb01060.x.
- Background: PubMed 9603533Da Costa A, Lelievre H, Kirkorian G, Celard M, Chevalier P, Vandenesch F, Etienne J, Touboul P. Role of the preaxillary flora in pacemaker infections: a prospective study. Circulation. 1998 May 12;97(18):1791-5. doi: 10.1161/01.cir.97.18.1791.
- Background: PubMed 9603534Da Costa A, Kirkorian G, Cucherat M, Delahaye F, Chevalier P, Cerisier A, Isaaz K, Touboul P. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation. 1998 May 12;97(18):1796-801. doi: 10.1161/01.cir.97.18.1796.
- Background: PubMed 19808441de Oliveira JC, Martinelli M, Nishioka SA, Varejao T, Uipe D, Pedrosa AA, Costa R, D'Avila A, Danik SB. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):29-34. doi: 10.1161/CIRCEP.108.795906. Epub 2009 Feb 10.
- Background: PubMed 17481444Sohail MR, Uslan DZ, Khan AH, Friedman PA, Hayes DL, Wilson WR, Steckelberg JM, Stoner S, Baddour LM. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol. 2007 May 8;49(18):1851-9. doi: 10.1016/j.jacc.2007.01.072. Epub 2007 Apr 23.
- Background: PubMed 19036758Lekkerkerker JC, van Nieuwkoop C, Trines SA, van der Bom JG, Bernards A, van de Velde ET, Bootsma M, Zeppenfeld K, Jukema JW, Borleffs JW, Schalij MJ, van Erven L. Risk factors and time delay associated with cardiac device infections: Leiden device registry. Heart. 2009 May;95(9):715-20. doi: 10.1136/hrt.2008.151985. Epub 2008 Nov 26.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cefalexin 500 mg qid or roxithromycin 150 mg bid in people with Infection, Bacterial and Pacemaker Complication, run by Kaplan Medical Center.
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 1 inclusion and 7 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshe Swissa, MD (97250873523, Swissam@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound infection (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148444, which also lists 8 linked publications.
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 11 May 2017.