Antifungal Drugs in Pulmonary Mucormycosis

Evaluation on Efficacy and Safety of Liposomal Amphotericin B(AmBisome® ) Combination with Isavuconazole Versus AmBisome® Alone for Treatment of Patients with Pulmonary Mucormycosis

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06756191

Enrollment

312

Registered

2025-01-01

Start date

2025-01-10

Completion date

2026-12-31

Last updated

2025-01-01

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

Conditions

Pulmonary Mucormycosis

Keywords

Pulmonary Mucormycosis, Amphotericin B liposome, isavuconazole

Brief summary

Pulmonary mucormycosis (PM) poses a substantial clinical challenge, particularly among immunocompromised patients. The aim of the study is to determine the effectiveness and safety of administering AmBisome at a dose of 5mg/kg/day combined with isavuconazole versus using AmBisome for the management of pulmonary mucormycosis

Interventions

DRUGCombination therapy group

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

DRUGLiposomal Amphotericin B

Liposomal amphotericin B (AmBisome®) alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM). * Individuals with Probable or proved PM, as indicated by clinical and radiological findings.

Exclusion criteria

* Patients with a history of pulmonary mucormycosis (PM) who have previously been treated with amphotericin B for a duration exceeding 5 days. * Patients who have documented allergies to azoles or amphotericin B regimens * Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin levels exceeding five times the upper limit of normal (ULN). * Patients with irreversible heart or liver failure, or those experiencing massive, fatal hemoptysis. * Patients who have experienced a myocardial infarction or cerebral infarction. * Patients currently receiving extracorporeal membrane oxygenation (ECMO) treatment. * Pregnant or breastfeeding individuals. 8.Patients with individual reasons that may prevent them from completing the treatment protocol.

Design outcomes

Primary

Measure	Time frame	Description
4-week favourable response rate	4 week	The percentage of patients with favourable response by 4 week. Favourable response is defined as lesion absorption in chest CT.

Secondary

Measure	Time frame	Description
Frequency of adverse events	4 week	Treatment-related adverse event frequency
24-week mortality	24 week	Defined as the proportion of patients who died by week 24.
12-week mortality	12 week	Defined as the proportion of patients who died by 12 week.

Contacts

Primary ContactBin Cao, M.D.

zhibo_liu1985@163.com+010086 15210682464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026