Antifungal Drugs in Pulmonary Mucormycosis

Bin Cao

Status and phase: Not yet enrolling; Phase 4

Conditions: Pulmonary Mucormycosis

Treatments: Drug: Combination therapy group; Drug: Liposomal Amphotericin B

Study type: Interventional

Funder types: Other

Identifiers

NCT06756191

2024-KY-413

Details and patient eligibility

About

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

Enrollment: 312 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 2 patient groups

Single drug group

Active Comparator group

Description:

Liposomal amphotericin B (AmBisome®)

Treatment:

Drug: Liposomal Amphotericin B

Combination therapy

Experimental group

Description:

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Treatment:

Drug: Combination therapy group