Evaluation of optimal infusion volume with liposomal amphotericin B (L-AMB) administration for chronic pulmonary aspergillosis

Evaluation of optimal infusion volume with liposomal amphotericin B (L-AMB) administration for chronic pulmonary aspergillosis - Evaluation of optimal infusion volume with liposomal amphotericin B (L-AMB) administration for chronic pulmonary aspergillosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012687

Enrollment

Registered

2013-12-25

Start date

2013-10-16

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic pulmonary aspergillosis

Interventions

L-AMB is given intravenously at 3.0mg/kg every 24h for 2 weeks. L-AMB is given intravenously at 3.0mg/kg every 24h for 2 weeks after undertaking Sordem 3A 500ml.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Chronic respiratory symptom or systemic symptom; i.e. the existence of at least one of the symptoms of fever, weight loss, sputum, cough, hemoptysis, fatigue, and dyspnea (2) New infiltrates or cavity formation or expansion of pre-existing cavities with or without peri-cavitary infiltrates and adjacent pleural thickening in last six months. (3) At least one positive result of serologic tests including Aspergillus antigen test, antibody test and/or any positive evidences if existence of Aspergillus species by molecular diagnosis, culture positive and pathological findings. (4) Positive findings of at least one of the inflammation markers such as white blood cell (WBC) counts, value of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR).

Exclusion criteria

Exclusion criteria: 1.Patients who received L-AMB within one month before the time of enrollment 2.Patients with intravenous leukocyte infusion 3.Pregnant patients 4.Patients with renal insufficiency(CKD morethan 3b) 5.Patients anticipating being postrenal failure using abdominal ultracound 6.Patients with cardiac disorders(EF less than 50% or E/A more than 1 using echocardiography) 7.Patients deemed ineligible by the attending physicians for various reasons.

Design outcomes

Primary

Measure	Time frame
Comparison of the renal dysfunction between hydration group and non-hydration group	—

Secondary

Measure	Time frame
The change of various electrolytes The change of renal dysfunctional marker The change of body weight	—

Countries

Japan

Contacts

Public ContactToshinori Kawanami

University of Occupational and Environmental Health, Japan Department of Respiratory Medicine

namihei@med.uoeh-u.ac.jp093-691-7453

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026