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Efficacy and Safety of Different Doses of Amphotericin B Liposomes in the Treatment of Disseminated Cryptococcus neoformans Infection: A Multicentre, Prospective, Open-Label Randomized Controlled Trial.

Efficacy and Safety of Different Doses of Amphotericin B Liposomes in the Treatment of Disseminated Cryptococcus neoformans Infection: A Multicentre, Prospective, Open-Label Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116101
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Talaromycosis

Interventions

Low-dose continuous therapy group:The patient received a 14-day course of intravenous amphotericin B liposomal therapy at a dose of 3–5 mg/kg/day.
High-dose single-treatment group:Received a single intravenous dose of amphotericin B liposome at a dosage of 10mg/kg.

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Based on HIV screening, cases were divided into two groups: HIV-positive and HIV-positive. 3. The patient has clinical or (and) imaging manifestations of Marniffei basket disease, and the microbiological examination or pathological examination meets any one of the following: Sputum specimens, tracheal aspirate specimens, BALF specimens, lung biopsy specimens, pleural effusion, bone marrow smears, skin exudation hydraulic smears or lymph node smears were observed under a microscope after Riesch staining, and it was found that Marneffei, a typical fungus with a round or oval shape and obvious septum (often within macrophages); Sputum specimens, tracheal aspirate specimens, BALF specimens, lung biopsy specimens, pleural effusion, bone marrow smears, skin exudates, lymph node biopsy specimens or blood specimens were cultured and isolated or detected by high-throughput sequencing (NGS) or Marniffei nucleic acid testing (PCR) for Marniffei. Pathological histological examination of lung biopsy specimens, biopsy specimens of enlarged lymph nodes or lesion skin specimens revealed baskets of Marneffei, accompanied by purulent granulomatous changes, with central necrosis and extensive infiltration of mononuclear macrophages. 4. Disseminated infection: Involving two or more non-adjacent organ systems.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating patients; 2. Severe liver damage (Child-Pugh grade C); 3. Renal insufficiency (creatinine >= 5 times the upper limit of the normal value) or the need for hemodialysis; 4. Combined with other systemic fungal infections (cryptococcosis, candidiasis or mucor infection); 5. Those with active mycobacterial disease or currently undergoing chemotherapy; 6. People with mental illness or abnormal behavior; 7. Received systemic antifungal treatment within 48 hours of enrollment; 8. The researcher evaluated that there were other factors that were not suitable for enrollment (poor compliance); 9. Allergic to amphotericin B liposomes;

Design outcomes

Primary

MeasureTime frame
Acute kidney injury;

Secondary

MeasureTime frame
Adverse reactions, including renal dysfunction, anaemia, hypokalaemia, and hepatic dysfunction;All-cause mortality rate on day 14;Clinical response at days 7 and 14 of treatment;

Countries

China

Contacts

Public ContactChao Zhuo

The First Affiliated Hospital of Guangzhou Medical University

chaosheep@gzhmu.edu.cn+86 20 8306 2315

Outcome results

None listed

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