Status:

ENROLLING_BY_INVITATION

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

Lead Sponsor:

Beijing Tsinghua Chang Gung Hospital

Conditions:

Pulmonary Mucormycosis

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

Evaluation of the effectiveness and safety of transbronchoscopic local precision infusion of amphotericin B + transoral nebulized inhalation of amphotericin B + transbronchoscopic interventional debri...

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 n...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 30 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06495905

Start Date

July 30 2024

End Date

December 30 2025

Last Update

July 11 2024

Active Locations (1)

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Beijing TsingHua ChangGung hospital

Beijing, Beijing Municipality, China