Infection; Dialysis CatheterPhase 3NCT01483872
Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections
A Phase 3 study testing NAC/Tigecycline/Heparin combination lock solution and Standard anticoagulant (Heparin or Citrate) in people with Infection; Dialysis Catheter, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Infection; Dialysis Catheter
- What is being tested?
- NAC/Tigecycline/Heparin combination lock solution and Standard anticoagulant (Heparin or Citrate)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia.
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.
- Conditions
- Infection; Dialysis Catheter
- Being tested
- NAC/Tigecycline/Heparin combination lock solution, Standard anticoagulant (Heparin or Citrate)
- Keywords
- salvage infected hemodialysis catheters, novel catheter lock solution
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAC/Tigecycline/Heparin combination lock solutionDrug
Standard anticoagulant (Heparin or Citrate)Drug
| Study group | Role | What they receive |
|---|---|---|
| NAC/Tigecycline/Heparin combination lock solution | Experimental | A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter Receives: Drug: NAC/Tigecycline/Heparin combination lock solution |
| Standard anticoagulant (heparin or citrate) | Placebo comparator | Standard anticoagulant (heparin or citrate) Receives: Drug: Standard anticoagulant (Heparin or Citrate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: The study was stopped due to poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection; Dialysis CatheterStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saima Aslam, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483872
- Sponsor's protocol ID
- 101094
- Status last verified
- Aug 2019
- First submitted
- 26 Nov 2011
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35363884
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia.
- ClinicalTrials.gov ID
- NCT01483872
- Acronym / sponsor ID
- 101094
- Conditions
- Infection; Dialysis Catheter
- Keywords
- salvage infected hemodialysis catheters, novel catheter lock solution
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to poor enrollment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC/Tigecycline/Heparin combination lock solution | Experimental | Drug: NAC/Tigecycline/Heparin combination lock solutionA combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter |
| Standard anticoagulant (heparin or citrate) | Placebo comparator | Drug: Standard anticoagulant (Heparin or Citrate)Standard anticoagulant (heparin or citrate) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- The following patients will be excluded from study entry:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAC/Tigecycline/Heparin combination lock solution | Drug | NAC/Tigecycline/Heparin combination lock solution |
| Standard anticoagulant (Heparin or Citrate) | Drug | Standard anticoagulant (heparin or citrate) |
Primary outcome
Success Rate
Time frame: 90 days
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35363884Almeida 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NAC/Tigecycline/Heparin combination lock solution and Standard anticoagulant (Heparin or Citrate) in people with Infection; Dialysis Catheter, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01483872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.