Antifungal Drugs in Pulmonary Mucormycosis

December 25, 2024 updated by: Bin Cao

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

312

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single drug group
Liposomal amphotericin B (AmBisome®)
Drug: Liposomal Amphotericin B
Liposomal amphotericin B (AmBisome®) alone
Experimental: Combination therapy
Liposomal amphotericin B (AmBisome®) combination with Isavuconazole
Drug: Combination therapy group
Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bin Cao

Investigators

  • Principal Investigator: Bin Cao, China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2025

Primary Completion (Estimated)

July 10, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 25, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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