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Standard testing pathways for high-throughput sequencing in the precise diagnosis and treatment of respiratory tract infections

Standard testing pathways for high-throughput sequencing in the precise diagnosis and treatment of respiratory tract infections

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109706
Enrollment
Unknown
Registered
2025-09-24
Start date
2025-10-08
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Respiratory tract infection

Interventions

Pulmonary infection group in patients with acute exacerbation of COPD/ bronchiectasis:No
Pulmonary infection group of immunodeficient patients:No

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Acute exacerbation period of COPD patients It meets the diagnostic criteria for COPD and acute exacerbation of COPD. a. Core symptoms (at least two of the following are met) : Aggravated breathing difficulties (subjective perception or objective assessment, such as VAS score >=5); Coughing intensifies (with increased frequency or intensity); Increased sputum volume (=50% increase within 24 hours) or purulent sputum (yellow/green); b. Time range: The deterioration of symptoms occurred within 14 days. c. Accompanying symptoms (possible but not necessary) : Rapid breathing (respiratory rate >24 breaths per minute); Tachycardia (heart rate >95 beats per minute) Fever (body temperature >38°C); Changes in mental state (such as drowsiness, delirium). Simultaneously satisfy: The relevant clinical manifestations and imaging examinations support pulmonary infection. 2. Acute exacerbation period of patients with bronchiectasis: It meets the diagnostic criteria for acute exacerbation of bronchiectasis patients. The core symptoms are as follows a. Main clinical features (all must be met) : Coughing worsens, with a significant increase in the frequency or intensity of coughing. An increase in sputum volume or a change in its nature, with a significant increase in sputum volume (such as a 24-hour increase of >=50%), or purulent sputum (yellow/green); Breathing difficulties worsen, with shortness of breath after activity or during rest. b. Supporting characteristics (at least one must be met) : Fever (body temperature > 38?, other infections need to be ruled out); Hemoptysis (new or aggravated); Auscultation of the lungs reveals new moist rales or wheezing sounds. General symptoms such as fatigue and drowsiness have worsened. Imaging suggests new inflammation (such as new exudation shadows shown on chest CT); Elevated inflammatory markers (such as increased C-reactive protein, erythrocyte sedimentation rate, and white blood cell count). Simultaneously meet the following conditions: Relevant clinical manifestations (such as aggravated heart failure, etc.) and imaging examinations support pulmonary infection. 3. Patients in the immunodeficient pulmonary infection cohort: At least one of the following clinical manifestations related to an immunodeficient host is met: a. Primary immunodeficiency diseases (such as congenital immunodeficiency). b. Active malignant tumors, or malignant tumors within one year before the onset of CAP (excluding patients with local skin cancer or early-stage cancer, such as stage 1 lung cancer). C. H. IV infection with a CD4-type T lymphocyte count of less than 200 /µl or a proportion lower than 14%. d. After solid organ transplantation. e. After hematopoietic stem cell transplantation. f. Receive more than 20 mg of prednisone or an equivalent dose of glucocorticoids daily for more than 14 days, or receive a cumulative dose of more than 600 mg of prednisone or an equivalent dose of glucocorticoids g. Receive treatment with biological-based immunomodulatory drugs h. Receive treatment with antirheumatic drugs or other immunosuppressive drugs, such as cyclosporine, cyclophosphamide, hydroxychloroquine, methotrexate, etc Simultaneously meet the following conditions: Relevant clinical manifestations and imaging examinations support pulmonary infection.

Exclusion criteria

Exclusion criteria: Acute exacerbation period of COPD patients 1. Exclude patients with other respiratory diseases such as lung cancer, bronchial asthma, bronchiectasis, interstitial lung disease, and sleep apnea syndrome; 2. First-time diagnosed COPD patients. Acute exacerbation period of patients with bronchiectasis: 1. Combined with chronic obstructive pulmonary disease, bronchial asthma, idiopathic pulmonary interstitial fibrosis, active pulmonary tuberculosis, allergic bronchopulmonary aspergillosis, Kartagener syndrome, Young syndrome, after lobectomy. Patients in the immunodeficient pulmonary infection cohort: 1. Incomplete clinical information; 2. Exclude patients with other active lung diseases such as pulmonary embolism and non-infectious interstitial lung disease.

Design outcomes

Primary

MeasureTime frame
Case fatality rate;

Secondary

MeasureTime frame
Whether meaningful pathogens have been detected;

Countries

China

Contacts

Public ContactHongbin Chen

Peking University People's Hospital

chenhongbin_pkuph@163.com+86 186 1079 1078

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026