- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02040818
Treatment of Hemodialysis Catheter-Related Bacteremia
RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia
Patients who undergo hemodialysis via a tunneled catheter often develop bloodstream infections that arise from the catheter. There are several management options for treatment of such an infection, though the best option is not clearly delineated. Standard of care options include exchanging the catheter for a new one over a guide-wire and instilling a high concentration of an antibiotic directly into the catheter lumen. The investigators are planning to treat hemodialysis catheter bloodstream infections by one of two strategies: 1. Use of a novel antibiotic lock solution Or 2. Changing out the infected catheter for a new one. Both these options have comparable cure rates as shown in the medical literature. After obtaining informed consent, patients will be randomized to either treatment arm and will continue to receive all other standard medical care.
Specific Aim: To conduct a randomized clinical trial to demonstrate that the use of a novel antibiotic lock solution (consisting of N-acetylcysteine, tigecycline and heparin) is non-inferior to guide-wire exchange in the treatment of hemodialysis catheter-related bacteremia.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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-
California
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San Diego, California, Forenede Stater, 92103
- University of California, San Diego Medical Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter with bacteremia will be eligible for enrollment.
Exclusion Criteria:
- The following patients will be excluded: 1) patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent, 2) patient is allergic to NAC, tigecycline, minocycline, or heparin, 3) patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors, 4) patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema, 5) patient is pregnant or will become pregnant, 6) the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Antibiotic Lock Solution
|
|
Aktiv komparator: Guide-wire Exchange
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Treatment Success
Tidsramme: 28 days
|
The primary outcome is successful treatment of infection defined as clinical and microbiologic resolution of the initial bacteremia with absence of persistent or recurrent catheter-related bacteremia at day 28 (one week after end of treatment).
|
28 days
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
- Aslam S, Trautner BW, Ramanathan V, Darouiche RO. Pilot trial of N-acetylcysteine and tigecycline as a catheter-lock solution for treatment of hemodialysis catheter-associated bacteremia. Infect Control Hosp Epidemiol. 2008 Sep;29(9):894-7. doi: 10.1086/590192.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Infektioner
- Systemisk inflammatorisk responssyndrom
- Betændelse
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Sepsis
- Bakteriæmi
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Beskyttelsesagenter
- Antibakterielle midler
- Proteinsyntesehæmmere
- Respiratoriske midler
- Antikoagulanter
- Antioxidanter
- Modgift
- Frie radikale scavengers
- Ekspektoranter
- Heparin
- Acetylcystein
- N-monoacetylcystin
- Tigecyklin
Andre undersøgelses-id-numre
- RCT 131309
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