Clinical trial NCT06495905: Efficacy and Safety of Systematic Therapy and Bronchoscopic Interventional Treatment for Pulmonary Mucormycosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pulmonary Mucormycosis
Keywords: pulmonary mucormycosis
bronchoscopy
treatment
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Intervention, observational, Propensity Matching Analysis study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the rate of complete or partial response at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: the rate of complete or partial response at 12 weeks
timeFrame: 12 weeks
measure: Survival rate at 6 months
timeFrame: 6 months
measure: the incidence of adverse reactions related to this comprehensive treatment at 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TsingHua ChangGung hospital
state: Beijing
Study officials:
affiliation: Tsinghua University
name: Manting Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: