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Aerosol inhalation of amphotericin B in prevention of pulmonary fungal infection in high risk patients with hematological diseases: a prospective multiple center study

Aerosol inhalation of amphotericin B in prevention of pulmonary fungal infection in high risk patients with hematological diseases: a prospective multiple center study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040882
Enrollment
Unknown
Registered
2020-12-13
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Pulmonary fungal infection

Interventions

trial group:Aerosol inhalation of amphotericin B combined with primary prevention
control group:primary prevention

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old; 2. Gender: male or female; 3. Patients with hematological malignancies receiving chemotherapy (1) Newly diagnosed acute myeloid leukemia / myelodysplastic syndrome (AML / MDS): initial diagnosis with granulocytopenia ; or induction therapy predicts agranulocytosis for more than 10 days; (2) The patients with AML / MDS / ALL aged over 65 years were treated with chemotherapy; (3) Patients with relapsed or refractory AML / MDS / ALL received salvage chemotherapy. 4. Patients after hematopoietic stem cell transplantation: (1) Patients with grade III - IV acute GVHD after transplantation are expected to receive methylprednisolone >= 2mg / kg for more than one week; (2) Persistent agranulocytosis due to chemoradiotherapy or cellular immunotherapy after transplantation is expected to be more than one week. 5. Patients with severe aplastic anemia receiving ATG / ALG intensive immunotherapy.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. ECOG score >= 3; 3. Severe cardiopulmonary insufficiency; 4. Allergic to amphotericin B antifungal drugs; 5. Dyspnea.

Design outcomes

Primary

MeasureTime frame
Incidence of fungal infection;

Secondary

MeasureTime frame
Attributable mortality;

Countries

China

Contacts

Public ContactDepei Wu

The First Affiliated Hospital of Soochow University

sdfyec@163.com+86 13951102021

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026