EUCTR2020-001033-12-DK
Active, not recruiting
Phase 1
PROPHYLACTIC ANTIBIOTIC TREATMENTIN END-STAGE KIDNEY DISEASE AND CENTRAL VENOUS CATHETER ASHEMODIALYSIS VASCULAR ACCESS
iels Eske Bruun0 sites800 target enrollmentApril 17, 2020
ConditionsSevere infection in patients end stage kidney disease and in hemodialysis with CVC as vascular asscess.MedDRA version: 20.0Level: LLTClassification code 10023420Term: Kidney failure chronicSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Severe infection in patients end stage kidney disease and in hemodialysis with CVC as vascular asscess.
- Sponsor
- iels Eske Bruun
- Enrollment
- 800
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 300
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 500
Exclusion Criteria
- •Unable to give informed consent
- •Known intolerance to beta\-lactam antibiotics and clindamycin
- •Active infection treated with antibiotics.
- •Pregnancy. In women of childbearing age, an approved birth control must be ensured.
- •Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible
Outcomes
Primary Outcomes
Not specified
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