Central Line Fungal InfectionsPhase 4NCT00936910
Antifungal Locks to Treat Fungal-related Central Line Infections
A Phase 4 study testing amphotericin B liposomal (Ambisome) in people with Central Line Fungal Infections, run by Bill McGhee at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the usefulness of antifungal lock therapy with liposomal amphotericin B (Ambisome), in combination with systemic antifungal(s), in patients with catheter-related blood stream infections with fungal organisms, whose catheter has not been removed because of the continuing… Read more about this study
- Who is it for?
- Ages 30 days to 21 years
- Conditions the study is for
- Central Line Fungal Infections
- What is being tested?
- amphotericin B liposomal (Ambisome)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2010
- Phase
- Phase 4
- 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 30 days to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with intestinal insufficiency and central venous access.
- Culture positive fungal-related CRBSI.
- Females of childbearing potential will be eligible for the study.
- Ambisome carries a category B Pregnancy Risk Factor. Since this is a minimal pregnancy risk category, no special precautions will be taken to determine that the patient is not pregnant.
- HIV serostatus will not be determined for the purpose of participating in this study.
Who cannot join
- Patients less than 30 days of age
- Patients greater than 21 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: The Use of Antifungal Lock Therapy in Intestinal Failure and Other Patients
The purpose of this study is to evaluate the usefulness of antifungal lock therapy with liposomal amphotericin B (Ambisome), in combination with systemic antifungal(s), in patients with catheter-related blood stream infections with fungal organisms, whose catheter has not been removed because of the continuing critical need for central line access. The primary group of potential patients will be those with intestinal insufficiency, including post-op small bowel transplant recipients.
The recommendation of the Infectious Disease Society of America (IDSA) is to remove all catheters with fungal infections and treat systemically for 14 days after the last positive culture. However, in certain intestinal failure patients, removal of an infected line might significantly reduce or eliminate intravenous (IV) access and create a life threatening situation. Thus, the investigators' aim is to determine the usefulness of antifungal lock therapy in intestinal failure patients whose catheter has not been removed. The investigators' hope is to salvage central line catheters rather than to remove them.
Read the detailed description
This is a descriptive study in intestinal failure patients with catheter-related blood stream infections (CRBSI) with fungal organisms. At present, the recommendation of the Infectious Disease Society of America (IDSA) is to remove all catheters with fungal infections and treat systemically for 14 days after the last positive culture (2). However, in intestinal failure patients who have limited IV access, removal of a line infected with Candida albicans, although recommended, might significantly reduce intravenous access and create a life threatening situation. Thus, the purpose of this study is to evaluate the use of antifungal lock therapy with liposomal amphotericin B (Ambisome) in combination with systemic antifungal therapy in patients with fungal CRBSI, whose catheter has not been removed because of the continuing critical need for central line access. The research methods are as follows:
- Study patients will consist of in-patients hospitalized at Children's Hospital of Pittsburgh. From our intestinal failure patients followed by GI, Transplant, and Pediatric Surgical Services, we plan to enroll 25 patients. In addition, other patients with similar concerns regarding limited central venous access with catheter-related candidal bloodstream infection may also be considered for this protocol.
- The primary group of potential patients in the study will be patients with intestinal insufficiency, including post-op small bowel recipients, whose intravenous access is limited. Thus, when a fungal CRBSI is suspected, retention of the CVC will be highly desirable. Additional subjects potentially eligible for this study would include children with cancer, those status-post bone marrow transplant, etc. who have limited central venous access and have a documented catheter-related bloodstream infection secondary to candida.
- Once the fungal infection is established, the patient will be approached to participate in the study. The investigator(s) will fully explain the study and its benefits and risks to the patient and/or parent or guardian (if legally appointed for research) and consent and assent will be obtained.
- Upon enrollment, antifungal therapy will be instituted consisting of both systemic and antifungal lock therapy.
- Ambisome at a dose of 3-5 mg/kg/day (or other appropriate antifungal based upon standard of care) will be administered intravenously B. Antifungal lock therapy with Ambisome will be administered. It consists of the placing up to 2.3 ml (based upon specific catheter types and volumes) of concentrated Ambisome into the infected CVC and allowing it to dwell uninterruptedly for 8 to 12 hours per day. The concentration of Ambisome is 2 mg/ml in sterile water (4).
- Patients enrolled in the study will receive routine clinical care as in-patients of CHP and be monitored appropriately from an infectious disease perspective including daily blood cultures. Patients will be examined clinically for evidence of fungal-related complications (e.g., septic arthritis, endocarditis, etc.).
- The duration of antifungal lock therapy (in addition to IV systemic antifungal therapy) will be 10-14 days.
- After 5 days of antifungal lock therapy, the patient with a persistently positive fungal blood culture will be deemed a failure and antifungal lock therapy will be discontinued. There will be no further antifungal lock therapy permissible via this protocol and data collection for the patient will be completed as soon as possible. The primary service will be responsible for the removal of the line.
- With successful lock therapy, additional blood cultures through the catheter will be obtained on day 5 and day 30 (or later if subject is still on systemic antifungal agents) post antifungal lock for a test of cure.
- If a patient has a recurrence of fungal infection on culture on day 5 or day 30 post antifungal lock, pulse field gel electrophoresis will be performed on both the original and new isolate to determine if the fungal organism is the same.
- If the organism is the same based upon electrophoretic analysis, treatment will be deemed a failure
- If the organism is not the same, then another source for the infection will be investigated.
- Since the standard of care would have been to remove the CVC, the primary end point of the study will be the number and percent of patients who successfully received antifungal lock therapy, i.e., those patients with at least 2 negative fungal cultures before the completion of 5 days of antifungal lock therapy and whose CVCs were not removed. Secondary endpoints will include the number of days before the cultures become negative; the development of fungal-related complications (e.g., septic arthritis, endocarditis, etc.); and the development of recurrent candidemia on day 5 and day 30 post antifungal lock therapy.
- When medically appropriate, subjects may be discharged to complete their Ambisome® lock therapy at home. Instructions/training on how to administer lock therapy will be provided to the parents, guardian, or subject and contact with the research coordinator will be maintained while the patient is at home.
- A patient registry will be established and offered to all subjects with central line fungal infections treated with Ambisome® locks.
- Conditions
- Central Line Fungal Infections
- Being tested
- amphotericin B liposomal (Ambisome)
- Keywords
- central line fungal infections, antifungal lock therapy, Ambisome lock therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amphotericin B liposomal (Ambisome)Drug
Also called Ambisome
After enrollment, antifungal therapy will be instituted consisting of both systemic and antifungal lock therapy. Systemic therapy will be amphotericin B liposomal (Ambisome) administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing sufficient amphotericin B liposomal (Ambisome [2 mg/ml]) lock solution into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days (largest CVC = 2.3 mL).
| Study group | Role | What they receive |
|---|---|---|
| Antifungal lock-treated patients | Experimental | Intestinal failure and other patients with poor IV access and central line fungal-related infections will receive intravenous systemic antifungal therapy plus the instillation of Ambisome locks into the infected catheter. Receives: Drug: amphotericin B liposomal (Ambisome) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With 2 Negative Fungal Cultures After 5 Days of Combined Systemic Antifungal and Antifungal Lock Therapy and the CVC Was Not Removed
Records the number of patients with 2 negative fungal cultures after 5 days of combined systemic antifungal and antifungal lock therapy and the CVC was not removed
Measured: 5 days of antifungal lock treatment
Secondary outcomes (3)
The Number of Days Before the Infected Central Line Culture Becomes Negative
Records the mean number of days required for the cultures to become negative
Measured: 5 days of antifungal lock treatment
The Development of Fungal-related Complications
Records the number of fungal related adverse complications that occurred
Measured: Usually 1-28 days
Number of Participants With Negative Cultures on Day 5 and Day 30 During the Test of Cure Period Post Antifungal Lock
Records the number of participants with 2 negative cultures who completed the trial and had (-) test of cure cultures on day 5 and 30
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startSep 2006
- Primary completionAug 2010
- Study completionSep 2010
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 (14)Papers the sponsor has linked to this study.
- Other trials for Central Line Fungal InfectionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bill McGhee
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor-investigator, Bill McGhee, University of Pittsburgh
- Investigators
- Bill McGhee, PharmD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936910
- Sponsor's protocol ID
- Ambisome Locks at CHP
- Status last verified
- Sep 2017
- First submitted
- 2 Jul 2009
- Last updated
- 10 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The entire data for all patients from the clinical trial has been published. The reference is: McGhee W, Michaels M, Martin, J, et al. Antifungal Lock Therapy with Liposomal Amphotericin B: A Prospective Trial. Journal of the Pediatric Infectious Diseases Society. 2016;5 (1): 80-4.
Publications
Hall K, Farr B. Diagnosis and management of long-term central venous catheter infections. J Vasc Interv Radiol. 2004 Apr;15(4):327-34. doi: 10.1097/01.rvi.0000121405.46920.87.
PubMed 15064335Mermel LA, Farr BM, Sherertz RJ, Raad II, O'Grady N, Harris JS, Craven DE; Infectious Diseases Society of America; American College of Critical Care Medicine; Society for Healthcare Epidemiology of America. Guidelines for the management of intravascular catheter-related infections. Clin Infect Dis. 2001 May 1;32(9):1249-72. doi: 10.1086/320001. Epub 2001 Apr 3. No abstract available.
PubMed 11303260Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis. 1993 Aug;168(2):400-7. doi: 10.1093/infdis/168.2.400.
PubMed 8335977Schinabeck MK, Long LA, Hossain MA, Chandra J, Mukherjee PK, Mohamed S, Ghannoum MA. Rabbit model of Candida albicans biofilm infection: liposomal amphotericin B antifungal lock therapy. Antimicrob Agents Chemother. 2004 May;48(5):1727-32. doi: 10.1128/AAC.48.5.1727-1732.2004.
PubMed 15105127Johnson DC, Johnson FL, Goldman S. Preliminary results treating persistent central venous catheter infections with the antibiotic lock technique in pediatric patients. Pediatr Infect Dis J. 1994 Oct;13(10):930-1. doi: 10.1097/00006454-199410000-00015. No abstract available.
PubMed 7854895Viale P, Petrosillo N, Signorini L, Puoti M, Carosi G. Should lock therapy always be avoided for central venous catheter-associated fungal bloodstream infections? Clin Infect Dis. 2001 Dec 1;33(11):1947-8; author reply 1949-51. doi: 10.1086/323554. No abstract available.
PubMed 11692310Kuhn DM, George T, Chandra J, Mukherjee PK, Ghannoum MA. Antifungal susceptibility of Candida biofilms: unique efficacy of amphotericin B lipid formulations and echinocandins. Antimicrob Agents Chemother. 2002 Jun;46(6):1773-80. doi: 10.1128/AAC.46.6.1773-1780.2002.
PubMed 12019089Siegman-Igra Y, Anglim AM, Shapiro DE, Adal KA, Strain BA, Farr BM. Diagnosis of vascular catheter-related bloodstream infection: a meta-analysis. J Clin Microbiol. 1997 Apr;35(4):928-36. doi: 10.1128/jcm.35.4.928-936.1997.
PubMed 9157155Blot F, Nitenberg G, Chachaty E, Raynard B, Germann N, Antoun S, Laplanche A, Brun-Buisson C, Tancrede C. Diagnosis of catheter-related bacteraemia: a prospective comparison of the time to positivity of hub-blood versus peripheral-blood cultures. Lancet. 1999 Sep 25;354(9184):1071-7. doi: 10.1016/s0140-6736(98)11134-0.
PubMed 10509498Wey SB, Mori M, Pfaller MA, Woolson RF, Wenzel RP. Hospital-acquired candidemia. The attributable mortality and excess length of stay. Arch Intern Med. 1988 Dec;148(12):2642-5. doi: 10.1001/archinte.148.12.2642.
PubMed 3196127Eppes SC, Troutman JL, Gutman LT. Outcome of treatment of candidemia in children whose central catheters were removed or retained. Pediatr Infect Dis J. 1989 Feb;8(2):99-104.
PubMed 2704608Dato VM, Dajani AS. Candidemia in children with central venous catheters: role of catheter removal and amphotericin B therapy. Pediatr Infect Dis J. 1990 May;9(5):309-14. doi: 10.1097/00006454-199005000-00002.
PubMed 2352815Nucci M, Anaissie E. Should vascular catheters be removed from all patients with candidemia? An evidence-based review. Clin Infect Dis. 2002 Mar 1;34(5):591-9. doi: 10.1086/338714. Epub 2002 Jan 24.
PubMed 11810600Castagnola E, Marazzi MG, Tacchella A, Giacchino R. Broviac catheter-related candidemia. Pediatr Infect Dis J. 2005 Aug;24(8):747. doi: 10.1097/01.inf.0000172929.23419.cb. No abstract available.
PubMed 16094241
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Antifungal Lock Therapy in Intestinal Failure and Other Patients
- ClinicalTrials.gov ID
- NCT00936910
- Acronym / sponsor ID
- Ambisome Locks at CHP
- Conditions
- Central Line Fungal Infections
- Keywords
- central line fungal infections, antifungal lock therapy, Ambisome lock therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bill McGheeUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Sep 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Posted 10 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the usefulness of antifungal lock therapy with liposomal amphotericin B (Ambisome), in combination with systemic antifungal(s), in patients with catheter-related blood stream infections with fungal organisms, whose catheter has not been removed because of the continuing critical need for central line access. The primary group of potential patients will be those with intestinal insufficiency, including post-op small bowel transplant recipients.
The recommendation of the Infectious Disease Society of America (IDSA) is to remove all catheters with fungal infections and treat systemically for 14 days after the last positive culture. However, in certain intestinal failure patients, removal of an infected line might significantly reduce or eliminate intravenous (IV) access and create a life threatening situation. Thus, the investigators' aim is to determine the usefulness of antifungal lock therapy in intestinal failure patients whose catheter has not been removed. The investigators' hope is to salvage central line catheters rather than to remove them.
Detailed description
This is a descriptive study in intestinal failure patients with catheter-related blood stream infections (CRBSI) with fungal organisms. At present, the recommendation of the Infectious Disease Society of America (IDSA) is to remove all catheters with fungal infections and treat systemically for 14 days after the last positive culture (2). However, in intestinal failure patients who have limited IV access, removal of a line infected with Candida albicans, although recommended, might significantly reduce intravenous access and create a life threatening situation. Thus, the purpose of this study is to evaluate the use of antifungal lock therapy with liposomal amphotericin B (Ambisome) in combination with systemic antifungal therapy in patients with fungal CRBSI, whose catheter has not been removed because of the continuing critical need for central line access. The research methods are as follows:
- Study patients will consist of in-patients hospitalized at Children's Hospital of Pittsburgh. From our intestinal failure patients followed by GI, Transplant, and Pediatric Surgical Services, we plan to enroll 25 patients. In addition, other patients with similar concerns regarding limited central venous access with catheter-related candidal bloodstream infection may also be considered for this protocol.
- The primary group of potential patients in the study will be patients with intestinal insufficiency, including post-op small bowel recipients, whose intravenous access is limited. Thus, when a fungal CRBSI is suspected, retention of the CVC will be highly desirable. Additional subjects potentially eligible for this study would include children with cancer, those status-post bone marrow transplant, etc. who have limited central venous access and have a documented catheter-related bloodstream infection secondary to candida.
- Once the fungal infection is established, the patient will be approached to participate in the study. The investigator(s) will fully explain the study and its benefits and risks to the patient and/or parent or guardian (if legally appointed for research) and consent and assent will be obtained.
- Upon enrollment, antifungal therapy will be instituted consisting of both systemic and antifungal lock therapy.
- Ambisome at a dose of 3-5 mg/kg/day (or other appropriate antifungal based upon standard of care) will be administered intravenously B. Antifungal lock therapy with Ambisome will be administered. It consists of the placing up to 2.3 ml (based upon specific catheter types and volumes) of concentrated Ambisome into the infected CVC and allowing it to dwell uninterruptedly for 8 to 12 hours per day. The concentration of Ambisome is 2 mg/ml in sterile water (4).
- Patients enrolled in the study will receive routine clinical care as in-patients of CHP and be monitored appropriately from an infectious disease perspective including daily blood cultures. Patients will be examined clinically for evidence of fungal-related complications (e.g., septic arthritis, endocarditis, etc.).
- The duration of antifungal lock therapy (in addition to IV systemic antifungal therapy) will be 10-14 days.
- After 5 days of antifungal lock therapy, the patient with a persistently positive fungal blood culture will be deemed a failure and antifungal lock therapy will be discontinued. There will be no further antifungal lock therapy permissible via this protocol and data collection for the patient will be completed as soon as possible. The primary service will be responsible for the removal of the line.
- With successful lock therapy, additional blood cultures through the catheter will be obtained on day 5 and day 30 (or later if subject is still on systemic antifungal agents) post antifungal lock for a test of cure.
- If a patient has a recurrence of fungal infection on culture on day 5 or day 30 post antifungal lock, pulse field gel electrophoresis will be performed on both the original and new isolate to determine if the fungal organism is the same.
- If the organism is the same based upon electrophoretic analysis, treatment will be deemed a failure
- If the organism is not the same, then another source for the infection will be investigated.
- Since the standard of care would have been to remove the CVC, the primary end point of the study will be the number and percent of patients who successfully received antifungal lock therapy, i.e., those patients with at least 2 negative fungal cultures before the completion of 5 days of antifungal lock therapy and whose CVCs were not removed. Secondary endpoints will include the number of days before the cultures become negative; the development of fungal-related complications (e.g., septic arthritis, endocarditis, etc.); and the development of recurrent candidemia on day 5 and day 30 post antifungal lock therapy.
- When medically appropriate, subjects may be discharged to complete their Ambisome® lock therapy at home. Instructions/training on how to administer lock therapy will be provided to the parents, guardian, or subject and contact with the research coordinator will be maintained while the patient is at home.
- A patient registry will be established and offered to all subjects with central line fungal infections treated with Ambisome® locks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antifungal lock-treated patients | Experimental | Drug: amphotericin B liposomal (Ambisome)Intestinal failure and other patients with poor IV access and central line fungal-related infections will receive intravenous systemic antifungal therapy plus the instillation of Ambisome locks into the infected catheter. |
Who may qualify
- Ages
- 30 days to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with intestinal insufficiency and central venous access.
- Culture positive fungal-related CRBSI.
- Females of childbearing potential will be eligible for the study.
- Ambisome carries a category B Pregnancy Risk Factor. Since this is a minimal pregnancy risk category, no special precautions will be taken to determine that the patient is not pregnant.
- HIV serostatus will not be determined for the purpose of participating in this study.
Key exclusion criteria (2 listed)
- Patients less than 30 days of age
- Patients greater than 21 years of age
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 |
|---|---|---|
| amphotericin B liposomal (Ambisome)Also: AmbisomeAfter enrollment, antifungal therapy will be instituted consisting of both systemic and antifungal lock therapy. Systemic therapy will be amphotericin B liposomal (Ambisome) administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing sufficient amphotericin B liposomal (Ambisome [2 mg/ml]) lock solution into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days (largest CVC = 2.3 mL). | Drug | Antifungal lock-treated patients |
Primary outcome
Number of Patients With 2 Negative Fungal Cultures After 5 Days of Combined Systemic Antifungal and Antifungal Lock Therapy and the CVC Was Not Removed
Time frame: 5 days of antifungal lock treatment
Records the number of patients with 2 negative fungal cultures after 5 days of combined systemic antifungal and antifungal lock therapy and the CVC was not removed
3 secondary outcomes
The Number of Days Before the Infected Central Line Culture Becomes Negative
Time frame: 5 days of antifungal lock treatment
The Development of Fungal-related Complications
Time frame: Usually 1-28 days
Number of Participants With Negative Cultures on Day 5 and Day 30 During the Test of Cure Period Post Antifungal Lock
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15064335Hall K, Farr B. Diagnosis and management of long-term central venous catheter infections. J Vasc Interv Radiol. 2004 Apr;15(4):327-34. doi: 10.1097/01.rvi.0000121405.46920.87.
- Background: PubMed 11303260Mermel LA, Farr BM, Sherertz RJ, Raad II, O'Grady N, Harris JS, Craven DE; Infectious Diseases Society of America; American College of Critical Care Medicine; Society for Healthcare Epidemiology of America. Guidelines for the management of intravascular catheter-related infections. Clin Infect Dis. 2001 May 1;32(9):1249-72. doi: 10.1086/320001. Epub 2001 Apr 3. No abstract available.
- Background: PubMed 8335977Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis. 1993 Aug;168(2):400-7. doi: 10.1093/infdis/168.2.400.
- Background: PubMed 15105127Schinabeck MK, Long LA, Hossain MA, Chandra J, Mukherjee PK, Mohamed S, Ghannoum MA. Rabbit model of Candida albicans biofilm infection: liposomal amphotericin B antifungal lock therapy. Antimicrob Agents Chemother. 2004 May;48(5):1727-32. doi: 10.1128/AAC.48.5.1727-1732.2004.
- Background: PubMed 7854895Johnson DC, Johnson FL, Goldman S. Preliminary results treating persistent central venous catheter infections with the antibiotic lock technique in pediatric patients. Pediatr Infect Dis J. 1994 Oct;13(10):930-1. doi: 10.1097/00006454-199410000-00015. No abstract available.
- Background: PubMed 11692310Viale P, Petrosillo N, Signorini L, Puoti M, Carosi G. Should lock therapy always be avoided for central venous catheter-associated fungal bloodstream infections? Clin Infect Dis. 2001 Dec 1;33(11):1947-8; author reply 1949-51. doi: 10.1086/323554. No abstract available.
- Background: PubMed 12019089Kuhn DM, George T, Chandra J, Mukherjee PK, Ghannoum MA. Antifungal susceptibility of Candida biofilms: unique efficacy of amphotericin B lipid formulations and echinocandins. Antimicrob Agents Chemother. 2002 Jun;46(6):1773-80. doi: 10.1128/AAC.46.6.1773-1780.2002.
- Background: PubMed 9157155Siegman-Igra Y, Anglim AM, Shapiro DE, Adal KA, Strain BA, Farr BM. Diagnosis of vascular catheter-related bloodstream infection: a meta-analysis. J Clin Microbiol. 1997 Apr;35(4):928-36. doi: 10.1128/jcm.35.4.928-936.1997.
- Background: PubMed 10509498Blot F, Nitenberg G, Chachaty E, Raynard B, Germann N, Antoun S, Laplanche A, Brun-Buisson C, Tancrede C. Diagnosis of catheter-related bacteraemia: a prospective comparison of the time to positivity of hub-blood versus peripheral-blood cultures. Lancet. 1999 Sep 25;354(9184):1071-7. doi: 10.1016/s0140-6736(98)11134-0.
- Background: PubMed 3196127Wey SB, Mori M, Pfaller MA, Woolson RF, Wenzel RP. Hospital-acquired candidemia. The attributable mortality and excess length of stay. Arch Intern Med. 1988 Dec;148(12):2642-5. doi: 10.1001/archinte.148.12.2642.
- Background: PubMed 2704608Eppes SC, Troutman JL, Gutman LT. Outcome of treatment of candidemia in children whose central catheters were removed or retained. Pediatr Infect Dis J. 1989 Feb;8(2):99-104.
- Background: PubMed 2352815Dato VM, Dajani AS. Candidemia in children with central venous catheters: role of catheter removal and amphotericin B therapy. Pediatr Infect Dis J. 1990 May;9(5):309-14. doi: 10.1097/00006454-199005000-00002.
- Individual participant dataSharing planned: Yes. The entire data for all patients from the clinical trial has been published. The reference is: McGhee W, Michaels M, Martin, J, et al. Antifungal Lock Therapy with Liposomal Amphotericin B: A Prospective Trial. Journal of the Pediatric Infectious Diseases Society. 2016;5 (1): 80-4.
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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.
Bill McGhee, PharmD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amphotericin B liposomal (Ambisome) in people with Central Line Fungal Infections, run by Bill McGhee 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 5 inclusion and 2 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 10 Oct 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 10 Oct 2017). 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?
Number of Patients With 2 Negative Fungal Cultures After 5 Days of Combined Systemic Antifungal and Antifungal Lock Therapy and the CVC Was Not Removed (time frame: 5 days of antifungal lock treatment). 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 NCT00936910, which also lists 14 linked publications.
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 10 Oct 2017.