End-Stage Renal DiseasePhase 1NCT00614679
A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia
A Phase 1 study testing catheter lock solution consisting of N-acetylcystein, tigecycline and heparin in people with End-Stage Renal Disease and Hemodialysis Catheter-associated Infection, run by University of California, San Diego at 3 sites in United States.
Trial summary
The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- End-Stage Renal Disease, Hemodialysis Catheter-associated Infection
- What is being tested?
- catheter lock solution consisting of N-acetylcystein, tigecycline and heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2006to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who have an indwelling hemodialysis catheter for 10 or more days and evidence of a catheter associated bloodstream infection as evidenced by 1)quantitative blood cultures obtained through the lumen of the catheter yield concentrations of bacterial colonies that are 5 or more fold higher than peripheral blood cultures, or 2)blood cultures obtained through the lumen of the catheter becomes positive 2 or more hours earlier than peripheral blood cultures.
Who cannot join
- Patients will be excluded if 1) they are unable or unwilling to provide informed consent, 2) have evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osetoemylitis, deep seated abscesses etc 3)evidence of an exit site infection around the catheter such as a pus pocket, drainage or erythema. 4) patient is allergic to NAC or the proposed antibiotic (if patient is allergic to minocycline, tigecycline will not be used). 5) patient is pregnant or will become pregnant.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ben Taub General Hospital
Houston, Texas, 77030
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. Secondary objectives include duration to clearance of bacteremia, future recurrence of bacteremia, need for catheter removal and death.
- Being tested
- catheter lock solution consisting of N-acetylcystein, tigecycline and heparin
- Keywords
- biofilm, catheter lock solution, catheter salvage
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter lock solution consisting of N-acetylcystein, tigecycline and heparinDrug
N-acetylcystein 80 mg/ml, tigecycline 1 mg/ml, and heparin 2000 units/ml. This will be a 5 ml catheter lock solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | single arm trial of experimental catheter lock solution Receives: Drug: catheter lock solution consisting of N-acetylcystein, tigecycline and heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success within 90 days
Measured: 90 days
Secondary outcomes (1)
catheter salvage
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 posted13 Feb 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT00614679
- Sponsor's protocol ID
- H-17624
- Status last verified
- Oct 2019
- First submitted
- 11 Feb 2008
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18643743
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia
- ClinicalTrials.gov ID
- NCT00614679
- Acronym / sponsor ID
- H-17624
- Keywords
- biofilm, catheter lock solution, catheter salvage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. Secondary objectives include duration to clearance of bacteremia, future recurrence of bacteremia, need for catheter removal and death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: catheter lock solution consisting of N-acetylcystein, tigecycline and heparinsingle arm trial of experimental catheter lock solution |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who have an indwelling hemodialysis catheter for 10 or more days and evidence of a catheter associated bloodstream infection as evidenced by 1)quantitative blood cultures obtained through the lumen of the catheter yield concentrations of bacterial colonies that are 5 or more fold higher than peripheral blood cultures, or 2)blood cultures obtained through the lumen of the catheter becomes positive 2 or more hours earlier than peripheral blood cultures.
Key exclusion criteria (1 listed)
- Patients will be excluded if 1) they are unable or unwilling to provide informed consent, 2) have evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osetoemylitis, deep seated abscesses etc 3)evidence of an exit site infection around the catheter such as a pus pocket, drainage or erythema. 4) patient is allergic to NAC or the proposed antibiotic (if patient is allergic to minocycline, tigecycline will not be used). 5) patient is pregnant or will become pregnant.
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 |
|---|---|---|
| catheter lock solution consisting of N-acetylcystein, tigecycline and heparinN-acetylcystein 80 mg/ml, tigecycline 1 mg/ml, and heparin 2000 units/ml. This will be a 5 ml catheter lock solution | Drug | 1 |
Primary outcome
Treatment success within 90 days
Time frame: 90 days
1 secondary outcome
catheter salvage
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 18643743Aslam 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.
Related trials for End-Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing catheter lock solution consisting of N-acetylcystein, tigecycline and heparin in people with End-Stage Renal Disease and Hemodialysis Catheter-associated Infection, run by University of California, San Diego at 3 sites 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 1 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: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment success within 90 days (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 NCT00614679, 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 9 Oct 2019.