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Oral dicloxacillin for prevention of exit site infection after permanent tunneled cuffed catheter insertion in hemodialysis patient: A double-blinded, randomized, controlled study

Oral Dicloxacillin for prevention of Exit site infection after perManEnt tunneled cuffed catheTER insertion in hemodialysis patient: A double-blinded, randomized, controlled study (DEMETER study)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20181001004
Enrollment
100
Registered
2018-10-01
Start date
2018-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis patients requiring permanent tunneled cuffed catheter insertion Tunneled cuffed catheter Permanent catheter Exit site infection Catheter&#45

Interventions

Oral dicloxacillin 250 mg orally 4 times per day after tunneled cuffed catheter insertion for 7 days.,Matching placebo orally 4 times per day after tunneled cuffed catheter insertion for 7 days.
Experimental Drug,Placebo Comparator Drug
Dicloxacillin,Placebo

Sponsors

Renal Division, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years old 2. End stage kidney disease with estimated glomerular filtration rate (eGFR) less than 15 ml/min/1.73 m2 by CKD-EPI equation requiring hemodialysis

Exclusion criteria

Exclusion criteria: 1. Allergy to penicillin 2. Active skin infection at the site of catheter insertion 3. Evidence of systemic infection requiring antimicrobial therapy

Design outcomes

Primary

MeasureTime frame
Exit site infection 28 days Defined according to Center for Disease Control and Prevention (CDC) guideline—

Secondary

MeasureTime frame
Catheter-related blood stream infection 28 days Blood cutures—

Countries

Thailand

Contacts

Public ContactKajohnsak Noppakun

Chiang Mai University

kajohnsak.noppakun@cmu.ac.th+66815953465

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026