Prophylactic Antibiotic Treatment in Hemodialysis (PANTHEM)
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- STATUS
- Recruiting
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- End date
- May 5, 2028
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- participants needed
- 800
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- sponsor
- Zealand University Hospital
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.
Description
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.
Details
| Condition | Hemodialysis |
|---|---|
| Treatment | Amoxicillin Clavulanic 500/125mg or placebo |
| Clinical Study Identifier | NCT05248620 |
| Sponsor | Zealand University Hospital |
| Last Modified on | 5 June 2022 |
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