Actively Recruiting
A Multi-centre, Randomized, Double-blind, Active Controlled, Parallel Groups Study to Evaluate the Efficacy and Safety of Intravenous HRS9432 in Patients With Candidemia and/or Invasive Candidiasis
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2024-11-18
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects and safety of an intravenous drug called HRS9432 in adults diagnosed with candidemia and/or invasive candidiasis, which are serious fungal infections. This Phase II, multi-center trial aims to compare HRS9432 to an active control drug in patients showing systemic signs related to these infections. The study is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. and uses a randomized, double-blind design to assess treatment outcomes. Participants will receive either HRS9432 intravenously once a week or Caspofungin Acetate intravenously with a loading dose followed by daily doses. The study involves parallel groups and evaluates treatments over several time points, including early and extended follow-up periods. The main goal is to observe the overall success of treatment by checking fungal eradication and resolution of infection symptoms. During the study, participants will undergo various assessments including microbiological tests, clinical evaluations, and safety monitoring. These evaluations occur at specific days during treatment and follow-up, extending up to 56 days after the last dose. Researchers will monitor adverse events and measure outcomes such as clinical cure, fungal clearance, mortality, and recurrence of infection. Participation involves scheduled visits for testing and observation to track treatment effects and safety.
CONDITIONS
Brief 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 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...
- Having forms of invasive candidiasis such as osteomyelitis, endocarditis, myocarditis, meningitis, endophthalmitis, central nervous system infection, urinary tract infection, or chronic disseminated candidiasis
- Severe liver impairment with chronic cirrhosis history
- History of severe ataxia, tremor, neuropathy, multiple sclerosis, or movement disorders
- Abnormal laboratory results at screening
- Clinically significant ECG abnormalities posing safety risk
- Prior systemic antifungal treatment for candidemia or invasive candidiasis for more than 48 hours
- 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 before randomization
- Participation in another investigational drug study within 5 half-lives or prior to screening
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Known allergy or hypersensitivity to HRS9432, caspofungin, or related drugs
- Other reasons judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks or until discontinuation
Participants receive intravenous HRS9432 once weekly or Caspofungin Acetate intravenously daily as treatment for candidemia and/or invasive candidiasis.
Weekly visits for up to 4 weeks
Duration - Up to 8 weeks after treatment
Participants are monitored for safety, clinical cure, and mycological success after treatment ends.
Approximately 3 follow-up visits
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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