Amoxicillin Clavulanic 500/125mg or placebo
DrugProphylactic antibiotic treatment
Other names: Aurobindo
NCT Number: NCT05248620
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Herlev-Gentofte Hospital, Copenhagen, Capital Region, Denmark
After being informed about the study and potential risks all eligible patients, giving written informed consent will be included in the study. At week 0 patients will be randomized in a single blinded manner (participants and care providers) in a 1:1 manner to receive 500/125mg amoxicillin/clavulanic acid 30-120 minutes before each hemodialysis with a central venous catheter (CVC) as vascular access, or corresponding placebo. The timing of antibiotic administration has been established in a pilot-study in order to secure a sufficient concentration of antibiotics during the dialysis session. In case of side effects to amoxicillin/clavulanic acid, the prophylactic antibiotic will be shifted to 600mg clindamycin. Total treatment period with prophylactic antibiotics is 6 months, with a 1 year follow-up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible.
Prophylactic antibiotic treatment
Other names: Aurobindo
Time frame: ≤ 6 months after randomization
Hospitalization for BSI
Time frame: ≤ 6 months after randomization
Hospitalization ≥ 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 randomization
Each of the components in the primary endpoint
Time frame: ≤ 6 months after randomization
All-cause mortality
Time frame: ≤ 6 months after randomization
Hospitalization due to sepsis or septic shock
Time frame: ≤ 6 months after randomization
Infective endocarditis, osteomyelitis, and spondylodiscitis
Time frame: ≤ 6 months after randomization
Frequency of BSI autoinfection
Time frame: ≤ 6 months after randomization
Clostridium difficile infection - numbers and days of admission
Time frame: ≤ 6 months after randomization
Mortality due to infection
Time frame: ≤ 6 months after randomization
CVC removal due to CVC infection
Time frame: ≤ 6 months after randomization
Total use of antibiotics in Defined Daily Doses
Time frame: ≤ 6 months after randomization
Health-care related economic consequences due to hospitalization and treatment of the disease
Time frame: ≤ 6 months after randomization
ESBL infections - number of patients and days of admission
Time frame: ≤ 6 months after randomization
MRSA infections - number of patients and days of admission
Time frame: ≤ 6 months after randomization
CPO infections - number og patients and days of admission
Time frame: ≤ 6 months after randomization
VRE infections - number of patients and days of admission
Time frame: ≤ 6 months after randomization
Hospitalization with acute myocardial infarction, worsening heart failure or stroke
Contact information is provided by the study sponsor or research team.
Kasper K Iversen, Professor
CONTACT
Niels E Bruun, Professor
CONTACT
Zealand University Hospital
Other
Prophylactic Antibiotic Treatment in End Stage Kidney Disease and Central Venous Catheter as Hemodialysis Vascular Access
Acronym: PANTHEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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