Efficacy and Safety of Systematic Therapy and Bronchoscopic Interventional Treatment for Pulmonary Mucormycosis

NCT ID: NCT06495905

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2025-12-30

Brief Summary

Evaluation of the effectiveness and safety of transbronchoscopic local precision infusion of amphotericin B + transoral nebulized inhalation of amphotericin B + transbronchoscopic interventional debridement + liposomal amphotericin B + posaconazole or Isavuconazole multimodal treatment of pulmonary mucormycosis

Detailed Description

Key rationale for the treatment of mucormycosis is early surgical intervention, including local debridement and removal of infected tissues or organs if possible. Systemic antifungal therapy is also necessary for mucormycosis, including amphotericin B liposomes and deoxycholates, Isavuconazole, posaconazole, and so on. Antifungal drug therapy has a mortality rate of up to 40%, which can be reduced to 23% when combined with surgical treatment. However, some patients who are unable to tolerate surgical procedures on the chest when in bad condition, especially patients with hematological malignancies undergoing hematopoietic stem cell transplantation, are susceptible to multiple mucormycosis of the lungs, and the mortality rate of untreated systemically disseminated mucormycosis infections is high at 80%. Isavuconazole, so we aim to explore the multimodal treatment of liposomal amphotericin B + posaconazole or esaconazole + transbronchoscopic localized precise instillation of amphotericin B + oral nebulized inhalation of amphotericin B + transbronchoscopic interventional debridement to alleviate the pulmonary mucormycosis in chest imaging and reduce the mortality rate of patients with mucormycosis infection.

Conditions

Pulmonary Mucormycosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multimodal Treatment

1. combination drug therapy：liposomal amphotericin B + posaconazole or Isavuconazole：3-5mg/kg/day+ Posaconazole 300 mg once daily; target blood trough concentration is >1ug/mL; if posaconazole is unavailable, Isavuconazole 200 mg once daily may be an alternative.

2. transbronchoscopic local precision infusion of amphotericin B: Maximum dose not more than 30mg per session

3. transoral nebulized inhalation of amphotericin B：amphotericin B 10mg + 5ml of sterilized water for injection, inhalation 2/day.

4)transbronchoscopic interventional debridement

Group Type: EXPERIMENTAL

transbronchoscopic interventional debridement

Intervention Type: PROCEDURE

1. combination drug therapy：liposomal amphotericin B + posaconazole or Isavuconazole：3-5mg/kg/day+ Posaconazole 300 mg once daily; target blood trough concentration is >1ug/mL; if posaconazole is unavailable, Isavuconazole 200 mg once daily may be an alternative.

2. transbronchoscopic local precision infusion of amphotericin B: Maximum dose not more than 30mg per session

3. transoral nebulized inhalation of amphotericin B：amphotericin B 10mg + 5ml of sterilized water for injection, inhalation 2/day.

4)transbronchoscopic interventional debridement

Interventions

transbronchoscopic interventional debridement

1. combination drug therapy：liposomal amphotericin B + posaconazole or Isavuconazole：3-5mg/kg/day+ Posaconazole 300 mg once daily; target blood trough concentration is >1ug/mL; if posaconazole is unavailable, Isavuconazole 200 mg once daily may be an alternative.

2. transbronchoscopic local precision infusion of amphotericin B: Maximum dose not more than 30mg per session

3. transoral nebulized inhalation of amphotericin B：amphotericin B 10mg + 5ml of sterilized water for injection, inhalation 2/day.

4)transbronchoscopic interventional debridement

Intervention Type: PROCEDURE

Other Intervention Names

transbronchoscopic local precision infusion of amphotericin B; transoral nebulized inhalation of amphotericin B; liposomal amphotericin B + posaconazole or Isavuconazole

Eligibility Criteria

Inclusion Criteria

• Subjects suspected of pulmonary mucormycosis by clinical radiology will be enrolled in the study if the pathologic or microbiological diagnosis of mucormycosis (smear showing sterile mycelium, culture or molecular evidence of mucormycosis) is confirmed.
• Cases of diffuse mucormycosis will only be included if lung infection is confirmed pathologically or microbiologically by respiratory secretions or biopsy samples.
• Ability to tolerate bronchoscopy.

Exclusion Criteria

• Pregnant and breastfeeding female patients
• Age <18 years
• Patients with HIV infection
• Contraindications to bronchoscopy (including platelet count < 100 x 109/L, active hemoptysis, severe respiratory or heart failure, severe arrhythmia, unstable angina or hypertension, severe pneumothorax or mediastinal emphysema, patients with acute myocardial infarction, cerebral infarction, and cerebral hemorrhage within 3 months
• Patients unable to tolerate bronchoscopy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manting Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Tsinghua University

Locations

Beijing TsingHua ChangGung hospital

Beijing, Beijing Municipality, China

Countries

China

References

Luo Q, He X, Xu J, Li L, Zhao L, Mu X. Reduced serum iron levels predict poor prognosis in pulmonary mucormycosis patients: a prospective, case-control study. Sci Rep. 2025 Aug 19;15(1):30395. doi: 10.1038/s41598-025-15186-3.

Reference Type: DERIVED

PMID: 40830172 (View on PubMed)

Other Identifiers

ST&BITPM

Identifier Type: -

Identifier Source: org_study_id