Antifungal Drugs in Pulmonary Mucormycosis

NCT06756191 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024-KY-413
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulmonary Mucormycosis

Keywords

Pulmonary Mucormycosis; Amphotericin B liposome; isavuconazole

Outcome Measures

Primary Outcomes (1)

• 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.

  4 week

Secondary Outcomes (3)

• 12-week mortality

  12 week

• 24-week mortality

  24 week

• Frequency of adverse events

  4 week

Study Arms (2)

Single drug group

ACTIVE COMPARATOR

Liposomal amphotericin B (AmBisome®)

Drug: Liposomal Amphotericin B

Combination therapy

EXPERIMENTAL

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Drug: Combination therapy group

Interventions

Combination therapy group DRUG

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Combination therapy

Liposomal Amphotericin B DRUG

Liposomal amphotericin B (AmBisome®) alone

Single drug group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM).
• Individuals with Probable or proved PM, as indicated by clinical and radiological findings.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bin Cao: lead

MeSH Terms

Interventions

liposomal amphotericin B

Study Officials

• Bin Cao

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Cao, M.D.

CONTACT

+010086 15210682464; zhibo_liu1985@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 1, 2025
• Study Start: January 10, 2025
• Primary Completion: July 10, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL