Antifungal Drugs in Pulmonary Mucormycosis

Phase 4

Not yet recruiting

• Conditions: Pulmonary Mucormycosis
• Interventions: Drug: Liposomal Amphotericin B; Drug: Combination therapy group

• Registration Number: NCT06756191
• Lead Sponsor: Bin Cao

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-25
• Last Update Submitted: 2024-12-25
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Study Start: 2025-01-10
• Primary Completion: 2025-07-10
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single drug group	Liposomal Amphotericin B	Liposomal amphotericin B (AmBisome®)
Combination therapy	Combination therapy group	Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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