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

NCT06495905 | Unknown DMC

• 1 other identifier: ST&BITPM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Mucormycosis

Keywords

pulmonary mucormycosis; bronchoscopy; treatment

Outcome Measures

Primary Outcomes (1)

• the rate of complete or partial response at 4 weeks

  * Complete response: Resolution of all clinical signs and symptoms and more than 90% of lesions visible on radiology * Partial response: Clinical improvement and \>50% improvement in findings on radiology

  4 weeks

Secondary Outcomes (3)

• the rate of complete or partial response at 12 weeks

  12 weeks

• Survival rate at 6 months

  6 months

• the incidence of adverse reactions related to this comprehensive treatment at 4 weeks

  4 weeks

Study Arms (1)

Multimodal Treatment

EXPERIMENTAL

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

Procedure: transbronchoscopic interventional debridement

Interventions

transbronchoscopic interventional debridement 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

Also known as: transbronchoscopic local precision infusion of amphotericin B, transoral nebulized inhalation of amphotericin B, liposomal amphotericin B + posaconazole or Isavuconazole

Multimodal Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing TsingHua ChangGung hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 40830172 DERIVED

MeSH Terms

Interventions

liposomal amphotericin B; posaconazole; isavuconazole

Study Officials

• Manting Liu, MD

  Tsinghua University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Intervention, observational, Propensity Matching Analysis study

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: July 11, 2024
• Study Start: July 30, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)