Last reviewed · How we verify
NCT02040818
RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia
Phase 2/Phase 3 trial testing tigecycline, N-acetylcysteine, heparin combination in Hemodialysis Catheter-related Bacteremia. Withdrawn.
1 January 2017
Quick facts
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Masking | none |
| Start date | 1 November 2013 |
| Primary completion | 1 January 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- tigecycline, N-acetylcysteine, heparin combination — full drug profile →
- guide-wire exchange
Conditions studied
- Hemodialysis Catheter-related Bacteremia — all drugs for Hemodialysis Catheter-related Bacteremia →
Sponsor
University of California, San Diego
Who can join
Adults 18 to 100, any sex, with Hemodialysis Catheter-related Bacteremia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Treatment Success
Time frame: 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).
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis.
Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. · · 2022 · cited 19× · PMID 35363884 · DOI 10.1002/14651858.cd013554.pub2
Verify or expand the search:
- PubMed search for NCT02040818
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02040818 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, San Diego
- Last refreshed: 6 October 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02040818.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing