HIV with pulmonary infections
Conditions
Interventions
Gold Standard:Detection of pathogenic microorganisms: clinical composite standard as a reference standard
Resistance: Phenotypic susceptibility as reference standard
Index test:Illumina Respiration Pathogen ID/AMR Panel (RPIP)
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age=18 years,HIV+ (HIV Combo test+ or PCR+, then with a positive confirmatory test by CDC)with suspicious pulmonary infections, bronchoscopy and collection of BALF specimens are required based on clinical judgment. Suspected criteria need to include: • Imaging findings, new infiltration, consolidation, ground glass-like changes on chest X-ray or CT, with or without pleural effusion • With at least one of the following clinical signs/symptoms/testing results: o New-onset cough or worsening of existing respiratory symptoms, with or without purulent sputum, chest pain, dyspnea, or hemoptysis o Body temperature >38? or 10×10ˆ9/L or < 4×10ˆ9/L; elevated CRP or PCT, etc. Specially screened bacteria-positive patients should meet: • Patients who are clinically judged to require bronchoscopy and sputum specimens are also available • Positive Xpert® MTB/RIF test for Mycobacterium tuberculosis
Exclusion criteria
Exclusion criteria: • Patients with contraindications to bronchoscopy • Pregnant woman • The patient or legal representative refuses or cannot understand the consent form • Other conditions that investigator need to exclude
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agreement rate with reference standard;sensitivity;specificity;Positive predictive value;Negative predictive value;95% exact confidence interval; | — |
Countries
China
Contacts
Public ContactWei Feili
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed