| DB ID | MyCo_5904 |
| Title | Sputum signatures for invasive pulmonary aspergillosis in patients with underlying respiratory diseases (SPARED): study protocol for a prospective diagnostic trial |
| Year | 2018 |
| PMID | 29890956 |
| Fungal Diseases involved | Invasive pulmonary aspergillosis |
| Associated Medical Condition | Underlying Respiratory diseases (SPARED) |
| Genus | Aspergillus |
| Species | fumigatus |
| Organism | Aspergillus fumigatus |
| Ethical Statement | This trial will be conducted in accordance with the Declaration of Helsinki. The Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University approved the study (No 2016–234). All participants will be volunteers, and a written informed consent form will be signed. Participants will be able to cease their involvement in the study at any time. If there are any changes to the protocol during the course of the study, an amendment will be submitted to the institutional review board for approval. |
| Site of Infection | None |
| Opportunistic invasive | Invasive |
| Sample type | Body fluid |
| Sample source | Sputum sample |
| Host Group | Human |
| Host Common name | Human |
| Host Scientific name | Homo sapiens |
| Biomarker Name | Aspergillus DNA |
| Biomarker Full Name | Aspergillus DNA |
| Biomarker Type | Diagnostic |
| Biomolecule | Protein |
| Geographical Location | China |
| Cohort | This is a prospective diagnostic trial. The study protocol has been registered with the Chinese Clinical Trial Registry (ChiCTR-DPD-16009070). Participants will be enrolled from respiratory wards and intensive care units in the West China Hospital, Sichuan University of China. At least 118 participants will be recruited from respiratory wards and intensive care units. IPA is defined according to the EORTC/MSG criteria modified for patients with URD. Induced sputum and blood will be collected, and BALF will be obtained by bronchoscopy. Sputum biomarkers, including galactomannan, Aspergillus DNA, triacetylfusarinine and bis(methylthio)gliotoxin will be determined, and the presence of a JF5 antigen will be examined with a lateral fluid device. |
| Cohort No. | 118 |
| Age Group | None |
| P Value | None |
| Sensitivity | None |
| Specificity | None |
| Positive Predictive Value | None |
| MIC | None |
| Fold Change | None |
| Pathway | None |
| Disease Introduction Mechanism | Invasive pulmonary aspergillosis (IPA) is a fungal infection that occurs primarily in patients with severe immunodeficiency. In recent years, IPA has been increasingly recognized in patients without haematologic malignancy or organ transplantation, especially in those with underlying respiratory diseases (URD). Remarkably, the mortality rate among non-neutropenic patients was significantly higher than that in neutropenic patients, such that a mortality rate of greater than 90% in patients with chronic obstructive pulmonary disease was reported. |
| Technique | PCR |
| Analysis Method | RT-PCR |
| ELISA kits | Platelia™ Aspergillus Ag Kit (BioRad, Hercules, CA, USA) |
| Assay Data | None |
| Validation Techniques used | GM-Platelia™ Aspergillus Ag ELISA, RT-PCR, High-performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) |
| Up Regulation Down Regulation | Positive |
| Sequence Data | None |
| External Link | None |
