Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia.
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Success Rate
Study Overview
Brief Summary
Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy.
The investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for treatment of their infection. Additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). The main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter and expected to continue hemodialysis for 3 months will be eligible for enrollment.
Exclusion Criteria
- •The following patients will be excluded from study entry:
- •patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent and
- •patient is allergic to NAC, tigecycline, minocycline, or heparin.
- •The following patients will be excluded from randomization:
- •patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors,
- •patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema,
- •patient is pregnant or will become pregnant,
- •the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.
Arms & Interventions
NAC/Tigecycline/Heparin combination lock solution
A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter
Intervention: NAC/Tigecycline/Heparin combination lock solution (Drug)
Standard anticoagulant (heparin or citrate)
Standard anticoagulant (heparin or citrate)
Intervention: Standard anticoagulant (Heparin or Citrate) (Drug)
Outcomes
Primary Outcomes
Success Rate
Time Frame: 90 days
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Secondary Outcomes
No secondary outcomes reported
Investigators
Saima Aslam
Asst Adjunct Prof
University of California, San Diego