CandidemiaSCATNCT06907992
A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
An observational study of Candidemia, run by Augusta University at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia
- What is being tested?
- Antifungal treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from: A. Inpatient settings based on positive blood cultures for candidemia. B. Daily review of microbiology labs C. Referrals from investigators, ICUs and hospital unit personnel
Who may be able to join
- Patients ≥ 18 years of age
- Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day 7.
- Received < 5 days of prior antifungal therapy
- Informed Consent for randomization
- Patients that did not consent to randomization have consented to be used as a natural history (controls) and will allow collection of available data from the medical record.
Who cannot join
- Inadequate source control (e.g., unable to remove endovascular devices, urinary catheters).
- Invasive candidiasis of any type (e.g., deep seated candidiasis from sources other than blood)
- Abnormal LFTs > 10-fold
- Greater than 5 days of prior antifungal therapy
- Endovascular devices that cannot be removed.
- Immunocompromised patients (AIDS/HIV; solid organ transplant, bone marrow transplant patients, oncology patients receiving chemotherapy, neutropenic patients (ANC of < 1,500 cells/L
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- Neutropenic at time of consent (what does this mean)
- Break-through candidemia (people with prior candidemia who relapsed) after treatment with antifungal therapy)
- Unable to provide informed consent from either the patient or legally authorized authority (LAR)
- Expected mortality within 96 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Short-Course Antifungal Therapy vs Standard of Care (14 Day Therapy) for Uncomplicated Candidemia (SCAT)
The goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality.
- Conditions
- Candidemia
- Being tested
- Antifungal treatment
- Keywords
- candidemia, uncomplicated candidemia, antifungal therapy, echinocandin, caspofungin, micafungin, rezafungin, anidulafungin
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antifungal treatmentDrug
Short-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days)
| Study group | Role | What they receive |
|---|---|---|
| 7 Days | Study participants randomized to the 7 Day group will receive the short-course antifungal therapy for 7 days. Receives: Drug: Antifungal treatment | |
| 14 Days | Study participants randomized to the 14 Day group will receive the standard of care antifungal therapy for 14 days. Receives: Drug: Antifungal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of candida from the blood at day 7 or day 14
Blood culture monitoring at day 7 and day 14
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Vazquez, Augusta University
- Investigators
- Jose Vazquez, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907992
- Sponsor's protocol ID
- MSG 23
- Other IDs
- U01CK000692
- Acronym
- SCAT
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Antifungal Therapy vs Standard of Care (14 Day Therapy) for Uncomplicated Candidemia (SCAT)
- ClinicalTrials.gov ID
- NCT06907992
- Acronym / sponsor ID
- SCAT / MSG 23
- Conditions
- Candidemia
- Keywords
- candidemia, uncomplicated candidemia, antifungal therapy, echinocandin, caspofungin, micafungin, rezafungin, anidulafungin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Apr 2025 (actual)
- 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 goal of this clinical trial is to assess whether a seven-day course of standard of care (echinocandin) antifungal therapy is non-inferior to a 14-day course of echinocandin antifungal therapy in patients with uncomplicated candidemia in terms of clinical, mycologic, adverse events and all cause mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 Days | – | Drug: Antifungal treatmentStudy participants randomized to the 7 Day group will receive the short-course antifungal therapy for 7 days. |
| 14 Days | – | Drug: Antifungal treatmentStudy participants randomized to the 14 Day group will receive the standard of care antifungal therapy for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from: A. Inpatient settings based on positive blood cultures for candidemia. B. Daily review of microbiology labs C. Referrals from investigators, ICUs and hospital unit personnel
Key inclusion criteria (5 listed)
- Patients ≥ 18 years of age
- Uncomplicated candidemia (positive blood culture only). No evidence of invasive candidiasis at day 1 or until day 7.
- Received < 5 days of prior antifungal therapy
- Informed Consent for randomization
- Patients that did not consent to randomization have consented to be used as a natural history (controls) and will allow collection of available data from the medical record.
Key exclusion criteria (10 listed)
- Inadequate source control (e.g., unable to remove endovascular devices, urinary catheters).
- Invasive candidiasis of any type (e.g., deep seated candidiasis from sources other than blood)
- Abnormal LFTs > 10-fold
- Greater than 5 days of prior antifungal therapy
- Endovascular devices that cannot be removed.
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 |
|---|---|---|
| Antifungal treatmentShort-course antifungal therapy (7 days) versus standard of care antifungal therapy (14 days) | Drug | 14 Days, 7 Days |
Primary outcome
Eradication of candida from the blood at day 7 or day 14
Time frame: 14 Days
Blood culture monitoring at day 7 and day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Candidemia
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children
Invasive Candidiasis
Not yet recruitingPhase 3
A Randomized Study of a Short Duration Therapy for Candidemia
CANDIDEMIA
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.
Jose Vazquez, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidemia, run by Augusta University 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 10 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: opening soon, as of the sponsor's last update on 4 Apr 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aprile Osborn, MSN (706-721-0309, aosborn@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of candida from the blood at day 7 or day 14 (time frame: 14 Days). 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 4 Apr 2025.