Catheter-Related Fungal InfectionsPhase 1NCT00809887
Micafungin Lock Therapy
A Phase 1 study testing Micafungin lock therapy in people with Catheter-Related Fungal Infections, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The study proposes to investigate, in children admitted at Children's Medical Center at Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination with systemic antifungal therapy in catheter-related fungal infections in order to salvage highly needed central venous catheter (CVC) and… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Catheter-Related Fungal Infections
- What is being tested?
- Micafungin lock therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Nov 2008
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children, 6 months-18 yrs, with a central line fungal infection, presumed Candida, admitted at Children's Medical Center.
- Signed informed consent by parents and assent by minor if applicable.
- Subjects with likely survival beyond 1 week.
Who cannot join
- Pocket, tunnel or exit-site infection
- Known allergic reactions to the Micafungin or echinocandins.
- Severe systemic symptoms (disseminated candidemia, fungal balls, endocarditis)
- Mixed infections
- Inability to lock the catheter lumen for minimum 8h because of other medications administration
- Subjects requiring ECMO or CVVH.
- Patients with HIV, congenital immunodeficiencies.
- Positive pregnancy test or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center of Dallas/University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Micafungin Lock Therapy to Clear Fungemia While Attempting to Preserve Central Venous Catheters
The study proposes to investigate, in children admitted at Children's Medical Center at Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination with systemic antifungal therapy in catheter-related fungal infections in order to salvage highly needed central venous catheter (CVC) and at the same time to investigate the effectiveness of Micafungin alone as systemic therapy in the treatment of Candidemia in a pediatric population.
Read the detailed description
The antimicrobial lock therapy (ALT) consists of filling a catheter lumen with a supraphysiologic concentration (100- to 1000- fold higher) of an antimicrobial agent and allowing it to dwell (lock) for several hours in an attempt to sterilize the lumen. Advantages of the ALT are: the ability to administer high local concentrations; the ease of administration; the cost-savings and vein access-savings by decreasing the number of surgical procedures in an operating room for catheter replacement; the decrease in possible surgical complications and risks. The Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America and others recommend the ALT for the treatment of uncomplicated bacteremias. This technique however is not currently recommended for the treatment of catheter-related fungal infections, primarily due to lack of adequate data. This study plans to enroll approximately 20 children admitted to the Children's Medical Center at Dallas in high need of central venous catheters or with evidence of fungemia in this study to investigate the effectiveness of ALT with Micafungin against fungal infections.
- Conditions
- Catheter-Related Fungal Infections
- Being tested
- Micafungin lock therapy
- Keywords
- catheter fungal infections, antimicrobial lock therapy, micafungin, central venous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micafungin lock therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | ALT with placebo with systemic Micafungin therapy Receives: Drug: Micafungin lock therapy |
| 2 | Experimental | ALT with Micafungin and heparin with systemic Micafungin therapy Receives: Drug: Micafungin lock therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h.
Measured: 96 hours
Secondary outcomes (1)
Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2008 (estimated)
- Study completionNov 2008
Why it stopped: Inability to enroll subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809887
- Sponsor's protocol ID
- 10882
- Status last verified
- Nov 2008
- First submitted
- 15 Dec 2008
- Last updated
- 17 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micafungin Lock Therapy to Clear Fungemia While Attempting to Preserve Central Venous Catheters
- ClinicalTrials.gov ID
- NCT00809887
- Acronym / sponsor ID
- 10882
- Conditions
- Catheter-Related Fungal Infections
- Keywords
- catheter fungal infections, antimicrobial lock therapy, micafungin, central venous catheter
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to enroll subjects
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Dec 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 study proposes to investigate, in children admitted at Children's Medical Center at Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination with systemic antifungal therapy in catheter-related fungal infections in order to salvage highly needed central venous catheter (CVC) and at the same time to investigate the effectiveness of Micafungin alone as systemic therapy in the treatment of Candidemia in a pediatric population.
Detailed description
The antimicrobial lock therapy (ALT) consists of filling a catheter lumen with a supraphysiologic concentration (100- to 1000- fold higher) of an antimicrobial agent and allowing it to dwell (lock) for several hours in an attempt to sterilize the lumen. Advantages of the ALT are: the ability to administer high local concentrations; the ease of administration; the cost-savings and vein access-savings by decreasing the number of surgical procedures in an operating room for catheter replacement; the decrease in possible surgical complications and risks. The Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America and others recommend the ALT for the treatment of uncomplicated bacteremias. This technique however is not currently recommended for the treatment of catheter-related fungal infections, primarily due to lack of adequate data. This study plans to enroll approximately 20 children admitted to the Children's Medical Center at Dallas in high need of central venous catheters or with evidence of fungemia in this study to investigate the effectiveness of ALT with Micafungin against fungal infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Micafungin lock therapyALT with placebo with systemic Micafungin therapy |
| 2 | Experimental | Drug: Micafungin lock therapyALT with Micafungin and heparin with systemic Micafungin therapy |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children, 6 months-18 yrs, with a central line fungal infection, presumed Candida, admitted at Children's Medical Center.
- Signed informed consent by parents and assent by minor if applicable.
- Subjects with likely survival beyond 1 week.
Key exclusion criteria (8 listed)
- Pocket, tunnel or exit-site infection
- Known allergic reactions to the Micafungin or echinocandins.
- Severe systemic symptoms (disseminated candidemia, fungal balls, endocarditis)
- Mixed infections
- Inability to lock the catheter lumen for minimum 8h because of other medications administration
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 |
|---|---|---|
| Micafungin lock therapy | Drug | 1, 2 |
Primary outcome
Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h.
Time frame: 96 hours
1 secondary outcome
Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin
Time frame: Up to one month
Results and safety
The study was stopped early (reason given: Inability to enroll subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2008.
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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 1 study testing Micafungin lock therapy in people with Catheter-Related Fungal Infections, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 3 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 17 Dec 2008. 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 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 was stopped early (reason given: Inability to enroll subjects). Results are not available in the source record.
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?
Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h. (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2008.