Antifungal Drugs in Pulmonary Mucormycosis

NCT ID: NCT06756191

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Pulmonary Mucormycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single drug group

Liposomal amphotericin B (AmBisome®)

Group Type ACTIVE_COMPARATOR

Liposomal Amphotericin B

Intervention Type DRUG

Liposomal amphotericin B (AmBisome®) alone

Combination therapy

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Group Type EXPERIMENTAL

Combination therapy group

Intervention Type DRUG

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Interventions

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Combination therapy group

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Intervention Type DRUG

Liposomal Amphotericin B

Liposomal amphotericin B (AmBisome®) alone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bin Cao

OTHER

Sponsor Role lead

Responsible Party

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Bin Cao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bin Cao

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Central Contacts

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Bin Cao, M.D.

Role: CONTACT

+010086 15210682464

Other Identifiers

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2024-KY-413

Identifier Type: -

Identifier Source: org_study_id

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