Prophylactic Antibiotic Treatment in Hemodialysis
ConditionHemodialysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable to give informed consent
Known intolerance to beta-lactam antibiotics and clindamycin
Active infection treated with antibiotics
Breastfeeding
Trial design
Design model
Parallel
Treatments tested in this trial
Amoxicillin Clavulanic 500/125mg or placebo
DrugProphylactic antibiotic treatment
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: ActiveActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with Blood stream infection (BSI)
Hospitalization for BSI
Time frame
≤ 6 months after randomization2
Number of patients with Severe blood culture negative infection
Hospitalization ≥ 3 days, or dies within 3 days, due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics
Time frame
≤ 6 months after randomizationSecondary outcomes
1
Number of patients with BSI or severe blood culture negative infection
Each of the components in the primary endpoint
Time frame
≤ 6 months after randomization2
Mortality
All-cause mortality
Time frame
≤ 6 months after randomizationOther outcomes
1
Number of patients with Sepsis
Hospitalization due to sepsis or septic shock
Time frame
≤ 6 months after randomization2
Number of patients with Deep tissue infection
Infective endocarditis, osteomyelitis, and spondylodiscitis
Time frame
≤ 6 months after randomization3
Number of patients with Autoinfection
Frequency of BSI autoinfection
Time frame
≤ 6 months after randomization4
Number of patients with Clostridium difficile infection
Clostridium difficile infection - numbers and days of admission
Time frame
≤ 6 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zealand University Hospital
Lead sponsor
Herlev Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Holbaek Sygehus
Collaborator
Nordsjaellands Hospital
Collaborator
Odense University Hospital
Collaborator
Aarhus University Hospital
Collaborator
Kolding Sygehus
Collaborator
Gødstrup Hospital
Collaborator
Viborg Regional Hospital
Collaborator
Aalborg University Hospital
Collaborator
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborator
Hospital of Southern Jutland
Collaborator
Source ClinicalTrials.gov