NCT06495905

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

Evaluation of the Effectiveness and Safety of Transbronchoscopic Infusion of Amphotericin B + Inhalation of Amphotericin B + Transbronchoscopic Debridement + Systematic Antifungal Multimodal Treatment of Pulmonary Mucormycosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2024-07-30
• Primary completion: 2025-07-30
• Completion: 2025-12-30
• First posted: 2024-07-11
• Last updated: 2024-07-11

Locations

1 site across 1 country: China