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Radial-EBUS-guided Transcatheter Amphotericin B for Refractory Chronic Pulmonary Fungal Infections: A Prospective Single-Arm Feasibility Trial

Radial-EBUS-guided Transcatheter Amphotericin B for Refractory Chronic Pulmonary Fungal Infections: A Prospective Single-Arm Feasibility Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117840
Enrollment
Unknown
Registered
2026-01-29
Start date
2024-08-18
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pulmonary Fungal Infections

Interventions

Perfusion therapy group:Transcatheter Amphotericin B

Sponsors

The Second Affiliated Hospital of the Army Medical University of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18–80 years, sex unrestricted. 2) Patients with invasive fungal infection (per the "Diagnostic Criteria and Treatment Principles for Invasive Pulmonary Fungal Infections [Draft]") or chronic pulmonary aspergillosis (including aspergilloma, Aspergillus nodule, chronic cavitary pulmonary aspergillosis, and chronic fibrosing pulmonary aspergillosis). 3) Able to receive standard antifungal therapy and ineligible for surgical curative resection. 4) Patients who have failed initial antifungal therapy. 5) Able to provide written informed consent (ICF) and willing/able to comply with study requirements and the evaluation schedule.

Exclusion criteria

Exclusion criteria: 1) Cases with missing key clinical data, including: absence of pathological or etiological evidence, imaging findings, or incomplete antifungal treatment records; 2) Patients unable to complete the clinical study; 3) Presence of any of the following contraindications to bronchoscopy: active massive hemoptysis; severe hypertension or arrhythmia; recent myocardial infarction or history of unstable angina; severe cardiac or pulmonary dysfunction (except those already receiving cardiopulmonary support); uncorrectable bleeding tendency (e.g., severe coagulation disorder), uremia, or severe pulmonary hypertension; severe superior vena cava syndrome, in which bronchoscopy may precipitate laryngeal edema and serious bleeding; suspected aortic aneurysm; multiple pulmonary bullae; extreme systemic debilitation; 4) Poor patient compliance or violation of trial protocols; 5) Pregnancy; 6) Any other condition that, in the opinion of the investigator, renders the patient unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Clinical domain;Radiological domain ;Mycological domain;

Secondary

MeasureTime frame
Treatment-Emergent Adverse Events (TEAEs) ;

Countries

China

Contacts

Public ContactZhang Mingzhou

The Second Affiliated Hospital of the Army Medical University of the People's Liberation Army of China

mingzhou06@163.com+86 136 6806 3932

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026