Once-a-Week IV antifungal tested against daily standard for dangerous candida infections
NCT ID NCT06194201
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing an experimental intravenous antifungal called HRS9432 in adults with candidemia or invasive candidiasis, serious infections caused by Candida yeast. The trial compares HRS9432 given once a week with caspofungin, a standard antifungal given daily. The main goal is to see whether HRS9432 clears the infection and resolves related signs as effectively as the daily treatment. About 61 participants will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental intravenous antifungal drug called HRS9432
- What this could lead to
- If it works, a once-weekly IV antifungal could simplify treatment for serious Candida bloodstream and deep-tissue infections, which often need daily infusions for weeks.
- What could go wrong
- This is a small phase 2 trial, so it may not show a clear difference from the standard daily drug. Antifungal resistance, side effects, or failure to clear the infection could limit any benefit.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
61 people
The number who actually took part.
- Started
-
Apr 2024
- Finished
-
Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or females ≥18 years; 2. Established or clinical diagnosis of candidemia and/or IC ; 3. Present of 1 or more systemic signs attribute to candidemia and/or IC 4 days prior to randomization; 4. Women of childbearing potential or male subjects whose partner is a fertile female agree to use highly effective form of contraception from the time of signed ICF till 6 months after end of treatment; 5. Able and willing to provide a written informed consent Exclusion Criteria: 1. Any of the following forms of IC: including osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, or any central nervous system infection, urinary tract infection or chronic disseminated candidiasis; 2. Severe hepatic impairment in subjects with a history of chronic cirrhosis; 3. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement; 4. Laboratory abnormalities in baseline specimens obtained at screening; 5. ECG with clinical significance and may cause obvious safety risk to the subjects at screening; 6. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for \>48 hours; 7. Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC; 8. A history of drug use, alcohol, or drug abuse within 1 year prior to randomization; 9. Participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to Screening; 10. Females who are in gestation or lactating period or planned pregnancy during the study 11. Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs; 12. In the judgment of the Investigator, other reasons unsuitable for study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, 421001, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Candida resistance study pulled before it began