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Efficacy and Safety of Liposomal Amphotericin B (AmBisome®) Plus Isavuconazole Versus AmBisome® in the Management of Pulmonary Mucormycosis: A multicenter, Prospective, Open Label, Randomized Controlled Study

Efficacy and Safety of Liposomal Amphotericin B (AmBisome®) Plus Isavuconazole Versus AmBisome® in the Management of Pulmonary Mucormycosis: A multicenter, Prospective, Open Label, Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095746
Enrollment
Unknown
Registered
2025-01-13
Start date
2025-01-13
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Pulmonary mucormycosis

Interventions

Liposomal Amphotericin B (AmBisome) Plus Isavuconazole:Liposomal Amphotericin B (AmBisome) Plus Isavuconazole
Liposomal Amphotericin B (AmBisome):Liposomal Amphotericin B (AmBisome)

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older diagnosed with pulmonary mucormycosis; 2.Individuals with Probable or proved PM, as indicated by clinical and radiological findings;

Exclusion criteria

Exclusion criteria: 1. Patients with a history of pulmonary mucormycosis (PM) who have previously been treated with amphotericin B for a duration exceeding 5 days. 2. Patients who have documented allergies to azoles or amphotericin B regimens; 3. Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin levels exceeding five times the upper limit of normal (ULN). 4. Patients with irreversible heart or liver failure, or those experiencing massive, fatal hemoptysis. 5. Patients currently receiving extracorporeal membrane oxygenation (ECMO) treatment. 6. Pregnant or breastfeeding individuals. 7. Patients with individual reasons that may prevent them from completing the treatment protocol.

Design outcomes

Primary

MeasureTime frame
The percentage of overall favourable responses at D28;

Secondary

MeasureTime frame
84 day-mortality;168 day-mortality;adverse event;

Countries

China

Contacts

Public ContactCao Bin

China-Japan Friendship Hospital

caobin_ben@163.com+86 10 84206264

Outcome results

None listed

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