Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Invasive Pulmonary Aspergillosis

Treatments: Drug: Amphotericin B

Study type: Interventional

Funder types: Other

Identifiers

NCT00986713

CYH-CMU AmB Neph

Details and patient eligibility

About

The purpose of this study is to determine whether inhalation with aerosolized amphoterin B 10mg/d is more effective than aerosolized amphoterin B 2mg/d to reduce the incidence of invasive pulmonary aspergillosis.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65ys≥age≥18ys
• renal transplant recipients

Exclusion criteria

• subjects with hypersensitivity to amphotericin B
• receipt of inhalational or intravenous amphotericin B within last 30 days
• subjects with known invasive fungal infection before renal transplant
• subjects with pneumonia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind