Chronic pulmonary aspergillosis
Conditions
Interventions
Administration of antifungal drugs (liposomalamphotericin B)
Administration of antifungal drug (voriconazole)
Sponsors
NEOCI (Nagasaki Evaluation Organization for Clinical Interventions)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CPA patients fulfilled with following conditions; #1. Diagnosis criteria; (1) existing al least one of symptom complex consisting of fever, weight loss, sputum, cough, hemoptysis, fatigue and shortness of breath. (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 inflamation markers such as white blood cell (WBC) counts, value of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). (5) non-improvement of symptoms to at least 3 days-administration of wide-broad intravenous antibiotics (e.g. carbapenems, wide-broad cephems and penicillins, and quinolones). #2. Patients who are given informed consents. #3. Patients who are at least 20 years or older. #4. Gender: male and female #5. Patients are hospitalized.
Exclusion criteria
Exclusion criteria: The following patients are excluded from the study. #1. Patients who are going to be excluded due to the difficulty of determine efficacy. (1) patients received amphotericin B (AMPH-B), liposomal amphotericin B (L-AMB) or voriconazole (VRCZ) within a month at the time of the diagnosis of CPA, (2) patients received other antifungal drugs such as itraconazole, flucytosine, miconazole, fluconazole, nystatin or micafungin and have already started to being improved or with unknown medical course. (3) patients who are diagnosed other than CPA. #2. Patients who are going to be excluded due to the safety issues. (1) patients who fulfilled the contraindication of AMPH-B, L-AMB and VRCZ. (2) patients with liver, kidney and heart failure (more than Grade II in CTCAEv3.0). (3) pregnant or breast feeding patients, and patients who are willing to have baby. #3. Patients whom are considered to be excluded by the attending physicians with various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of clinical symptoms and radiological findings in chest X-ray and CT at the two weeks after the initiation of drugs and the end of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of inflamatory markers and mycological findings at the two weeks after the initiation of the drugs and the end of the treatment. | — |
Countries
Japan
Contacts
Public ContactKoichi Izumikawa
Nagasaki University Second Department of Internal Medicine
Outcome results
None listed