Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2022-02-14
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Active
Amoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months
Amoxicillin Clavulanic 500/125mg or placebo
Prophylactic antibiotic treatment
Placebo
Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months
Amoxicillin Clavulanic 500/125mg or placebo
Prophylactic antibiotic treatment
Interventions
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Amoxicillin Clavulanic 500/125mg or placebo
Prophylactic antibiotic treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥18 years
* Ability to understand the study background, risk and benefit of treatment and to give written informed consent
Exclusion Criteria
* Known intolerance to beta-lactam antibiotics and clindamycin
* Active infection treated with antibiotics
* Breastfeeding
* Pregnancy. In women of childbearing age, an approved birth control must be ensured at least 1 month before and during all the 6 months of antibiotic/placebo treatment.
18 Years
ALL
No
Sponsors
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Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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Niels E Bruun, Professor
Role: PRINCIPAL_INVESTIGATOR
Dept. cardiology, Zealand University Hospital, Roskilde, Denmark
Locations
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Rigshospitalet
Copenhagen, Capital Region, Denmark
Herlev-Gentofte Hospital
Copenhagen, Capital Region, Denmark
North Zealand Hospital Hillerød
Hillerød, Capital Region, Denmark
Aarhus University Hospital
Aarhus, Middle Region, Denmark
Aalborg University Hospital
Aalborg, North Region, Denmark
ZUH Roskilde
Roskilde, Region Sjælland, Denmark
Odense University Hospital
Odense, Region South, Denmark
Countries
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Central Contacts
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Facility Contacts
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Anne-Lise Kamper, Consultant
Role: backup
Kasper K Iversen, Professor
Role: backup
References
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Gupta V, Yassin MH. Infection and hemodialysis access: an updated review. Infect Disord Drug Targets. 2013 Jun;13(3):196-205. doi: 10.2174/1871526511313030008.
Vogelzang JL, van Stralen KJ, Noordzij M, Diez JA, Carrero JJ, Couchoud C, Dekker FW, Finne P, Fouque D, Heaf JG, Hoitsma A, Leivestad T, de Meester J, Metcalfe W, Palsson R, Postorino M, Ravani P, Vanholder R, Wallner M, Wanner C, Groothoff JW, Jager KJ. Mortality from infections and malignancies in patients treated with renal replacement therapy: data from the ERA-EDTA registry. Nephrol Dial Transplant. 2015 Jun;30(6):1028-37. doi: 10.1093/ndt/gfv007. Epub 2015 Jan 29.
Aslam S, Vaida F, Ritter M, Mehta RL. Systematic review and meta-analysis on management of hemodialysis catheter-related bacteremia. J Am Soc Nephrol. 2014 Dec;25(12):2927-41. doi: 10.1681/ASN.2013091009. Epub 2014 May 22.
Sarnak MJ, Jaber BL. Mortality caused by sepsis in patients with end-stage renal disease compared with the general population. Kidney Int. 2000 Oct;58(4):1758-64. doi: 10.1111/j.1523-1755.2000.00337.x.
Jaber BL. Bacterial infections in hemodialysis patients: pathogenesis and prevention. Kidney Int. 2005 Jun;67(6):2508-19. doi: 10.1111/j.1523-1755.2005.00364.x. No abstract available.
de Jager DJ, Grootendorst DC, Jager KJ, van Dijk PC, Tomas LM, Ansell D, Collart F, Finne P, Heaf JG, De Meester J, Wetzels JF, Rosendaal FR, Dekker FW. Cardiovascular and noncardiovascular mortality among patients starting dialysis. JAMA. 2009 Oct 28;302(16):1782-9. doi: 10.1001/jama.2009.1488.
Chaudry MS, Gislason GH, Kamper AL, Rix M, Dahl A, Ostergaard L, Fosbol EL, Lauridsen TK, Oestergaard LB, Hassager C, Torp-Pedersen C, Bruun NE. The impact of hemodialysis on mortality risk and cause of death in Staphylococcus aureus endocarditis. BMC Nephrol. 2018 Sep 3;19(1):216. doi: 10.1186/s12882-018-1016-0.
Chaudry MS, Carlson N, Gislason GH, Kamper AL, Rix M, Fowler VG Jr, Torp-Pedersen C, Bruun NE. Risk of Infective Endocarditis in Patients with End Stage Renal Disease. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1814-1822. doi: 10.2215/CJN.02320317. Epub 2017 Oct 3.
Nelveg-Kristensen KE, Laier GH, Heaf JG. Risk of death after first-time blood stream infection in incident dialysis patients with specific consideration on vascular access and comorbidity. BMC Infect Dis. 2018 Dec 20;18(1):688. doi: 10.1186/s12879-018-3594-7.
Sakhuja A, Nanchal RS, Gupta S, Amer H, Kumar G, Albright RC, Kashani KB. Trends and Outcomes of Severe Sepsis in Patients on Maintenance Dialysis. Am J Nephrol. 2016;43(2):97-103. doi: 10.1159/000444684. Epub 2016 Mar 10.
Other Identifiers
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H-20026735
Identifier Type: -
Identifier Source: org_study_id
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