Prophylactic Antibiotic Treatment in Hemodialysis

NCT05248620 | Recruiting DMC

• 1 other identifier: H-20026735
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(HD), with a central venous catheter as vascular access.

Conditions

Hemodialysis

Keywords

Blood stream infections; Severe culture negative infections; Central venous catheter; Prophylactic antibiotics

Outcome Measures

Primary Outcomes (2)

• Number of patients with Blood stream infection (BSI)

  Hospitalization for BSI

  ≤ 6 months after randomization

• Number of patients with Severe blood culture negative infection

  Hospitalization ≥ 3 days due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics

  ≤ 6 months after randomization

Secondary Outcomes (2)

• Number of patients with BSI or severe blood culture negative infection

  ≤ 6 months after randomization

• Mortality

  ≤ 6 months after randomization

Other Outcomes (13)

• Number of patients with Sepsis

  ≤ 6 months after randomization

• Number of patients with Deep tissue infection

  ≤ 6 months after randomization

• Number of patients with Autoinfection

  ≤ 6 months after randomization

Study Arms (2)

Active

ACTIVE COMPARATOR

Amoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months

Drug: Amoxicillin Clavulanic 500/125mg or placebo

Placebo

PLACEBO COMPARATOR

Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months

Drug: Amoxicillin Clavulanic 500/125mg or placebo

Interventions

Amoxicillin Clavulanic 500/125mg or placebo DRUG

Prophylactic antibiotic treatment

Also known as: Aurobindo

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC for expected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) and hemodialysis access (AV-fistula or AV-graft))
• ≥18 years
• Ability to understand the study background, risk and benefit of treatment and to give written informed consent

You may not qualify if:

• Unable to give informed consent
• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (7)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

NOT YET RECRUITING

Herlev-Gentofte Hospital

Copenhagen, Capital Region, 2730, Denmark

RECRUITING

North Zealand Hospital Hillerød

Hillerød, Capital Region, 3400, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, Middle Region, 8200, Denmark

NOT YET RECRUITING

Aalborg University Hospital

Aalborg, North Region, 9100, Denmark

RECRUITING

ZUH Roskilde

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Odense University Hospital

Odense, Region South, 5000, Denmark

RECRUITING

Related Publications (10)

• 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.

  PMID: 24001331 BACKGROUND

• 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.

  PMID: 25637641 BACKGROUND

• 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.

  PMID: 24854263 BACKGROUND

• 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.

  PMID: 11012910 BACKGROUND

• 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.

  PMID: 15882306 BACKGROUND

• 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.

  PMID: 19861670 BACKGROUND

• 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.

  PMID: 30176809 BACKGROUND

• 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.

  PMID: 28974524 BACKGROUND

• 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.

  PMID: 30572826 BACKGROUND

• 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.

  PMID: 26959243 BACKGROUND

Study Officials

• Niels E Bruun, Professor

  Dept. cardiology, Zealand University Hospital, Roskilde, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels E Bruun, Professor

CONTACT

+4525159309; nbru@regionsjaelland.dk

Kasper K Iversen, Professor

CONTACT

Kasper.Karmark.Iversen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Amoxicillin/placebo is provided in identical containers. Amoxicillin and placebo tablets are looking similar, but by decision of the Danish Medicines Agency amoxicillin tablets must not be removed from the original folio packing prior to use. Clindamycin active and placebo tablets look similar (incapsulated), and are provided in identical containers. Study medicine will be provided by 1-2 nurses at each site, who are unblinded. The patients and care providers are blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, single-blinded, placebo controlled study, with blinded endpoint evaluation

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 21, 2022
• Study Start: February 14, 2022
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (7)