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Clinical study on pharmacokinetics and efficacy/nephrotoxicity of amphotericin B colloidal dispersion (ABCD)

Clinical study on pharmacokinetics and efficacy/nephrotoxicity of amphotericin B colloidal dispersion (ABCD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061439
Enrollment
Unknown
Registered
2022-06-25
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive fungal disease (IFD)

Interventions

Experimental group:amphotericin B colloidal dispersion

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with clinical intravenous use of amphotericin B cholesterol sulfate complex; 2. No gender limit, aged >=18 years; 3. Patients with febrile granulocyte deficiency, undefined IFD, suspected IFD, clinically diagnosed IFD, and confirmed IFD; 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with irregular dosage and time of amphotericin B cholesterol sulfate complex and no continuous administration for 6 days; 2. Patients with incorrect or incomplete blood collection time; 3. Pregnant and lactating patients, patients of childbearing age who refused to take effective contraceptive measures during the study period; 4. Patients who were also treated with amphotericin B in other forms during the study; 5. Patients who had been treated with amphotericin B and lipid formulates within one month prior to study initiation.

Design outcomes

Primary

MeasureTime frame
Effectiveness of treatment;

Secondary

MeasureTime frame
Incidence of acute kidney injury;The total hospital stay;All-cause mortality;Incidence of other adverse reactions;

Countries

China

Contacts

Public ContactZhang Xiaojian

The First Affiliated Hospital of Zhengzhou University

zhxj0524@sina.com+86 13803819758

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026