Pulmonary MucormycosisNCT06495905
Efficacy and Safety of Systematic Therapy and Bronchoscopic Interventional Treatment for Pulmonary Mucormycosis
A study testing transbronchoscopic interventional debridement in people with Pulmonary Mucormycosis, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Mucormycosis
- What is being tested?
- transbronchoscopic interventional debridement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- transbronchoscopic interventional debridement
- Keywords
- pulmonary mucormycosis, bronchoscopy, treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transbronchoscopic interventional debridementProcedure or surgery
Also called transbronchoscopic local precision infusion of amphotericin B, transoral nebulized inhalation of amphotericin B, liposomal amphotericin B + posaconazole or Isavuconazole
- 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.
- transbronchoscopic local precision infusion of amphotericin B: Maximum dose not more than 30mg per session
- transoral nebulized inhalation of amphotericin B：amphotericin B 10mg + 5ml of sterilized water for injection, inhalation 2/day.
4)transbronchoscopic interventional debridement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: transbronchoscopic interventional debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (3)
the rate of complete or partial response at 12 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
Measured: 12 weeks
Survival rate at 6 months
estimates using all-cause mortality at 12 months
Measured: 6 months
the incidence of adverse reactions related to this comprehensive treatment at 4 weeks
The adverse reactions were assessed based on the Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary MucormycosisStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Intervention, observational, Propensity Matching Analysis study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manting Liu, MD, Principal investigator, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495905
- Sponsor's protocol ID
- ST&BITPM
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40830172
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06495905
- Acronym / sponsor ID
- ST&BITPM
- Conditions
- Pulmonary Mucormycosis
- Keywords
- pulmonary mucormycosis, bronchoscopy, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Intervention, observational, Propensity Matching Analysis study
| Arm | Type | Receives |
|---|---|---|
| Multimodal Treatment | Experimental | Procedure: transbronchoscopic interventional debridement1. 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transbronchoscopic interventional debridementAlso: transbronchoscopic local precision infusion of amphotericin B, transoral nebulized inhalation of amphotericin B, liposomal amphotericin B + posaconazole or Isavuconazole1. 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 or surgery | Multimodal Treatment |
Primary outcome
the rate of complete or partial response at 4 weeks
Time frame: 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
3 secondary outcomes
the rate of complete or partial response at 12 weeks
Time frame: 12 weeks
Survival rate at 6 months
Time frame: 6 months
the incidence of adverse reactions related to this comprehensive treatment at 4 weeks
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 40830172Luo 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.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Mucormycosis
RecruitingObservational study
Chest CT Scan in Pulmonary Mucormycosis: Prognostic Value
Pulmonary Mucormycosis
Not yet recruitingPhase 4
Antifungal Drugs in Pulmonary Mucormycosis
Pulmonary Mucormycosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manting Liu, MD principal investigator
Tsinghua University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transbronchoscopic interventional debridement in people with Pulmonary Mucormycosis, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of complete or partial response at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06495905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.