Actively Recruiting
A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2024-11-18
40
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis
CONDITIONS
Official Title
A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Established or clinical diagnosis of candidemia and/or invasive candidiasis
- Presence of one or more systemic signs related to candidemia and/or invasive candidiasis within 4 days before randomization
- Women of childbearing potential and male participants with fertile partners agree to use highly effective contraception from consent until 6 months after treatment ends
- Able and willing to provide written informed consent
You will not qualify if you...
- Presence of invasive candidiasis forms such as osteomyelitis, endocarditis, myocarditis, meningitis, endophthalmitis, central nervous system infection, urinary tract infection, or chronic disseminated candidiasis
- Severe liver impairment with history of chronic cirrhosis
- History of severe ataxia, tremor, neuropathy, multiple sclerosis, or movement disorders
- Laboratory abnormalities in baseline screening tests
- Clinically significant ECG abnormalities posing safety risk
- Systemic antifungal treatment for candidemia or invasive candidiasis for more than 48 hours prior to randomization
- Presence of vascular catheter or device that cannot be removed or abscess that cannot be drained and may cause infection
- History of drug or alcohol abuse within 1 year prior to randomization
- Participation in other clinical studies with investigational drugs prior to screening
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Known allergy or hypersensitivity to HRS9432, caspofungin, or echinocandin drugs
- Other reasons deemed unsuitable by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China, 421001
Actively Recruiting
Research Team
X
Xiaopeng Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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