Antifungal Drugs in Pulmonary Mucormycosis

Phase 4Not Yet RecruitingNCT06756191

Bin Cao312 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

312

Conditions

Pulmonary Mucormycosis

Interventions

Combination therapy groupDRUG

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Liposomal Amphotericin BDRUG

Liposomal amphotericin B (AmBisome®) alone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

4-week favourable response rate

The percentage of patients with favourable response by 4 week. Favourable response is defined as lesion absorption in chest CT.

Time frame: 4 week

Secondary Outcomes

12-week mortality

Defined as the proportion of patients who died by 12 week.

Time frame: 12 week

24-week mortality

Defined as the proportion of patients who died by week 24.

Time frame: 24 week

Frequency of adverse events

Treatment-related adverse event frequency

Time frame: 4 week

Central Contacts

Bin Cao, M.D.

CONTACT

+010086 15210682464 zhibo_liu1985@163.com

Data from ClinicalTrials.gov

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