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Clinical application of LAMP combined with Xpert Carba-R in carbapenemase-producing gram-negative bacterial pneumonia

Clinical application of LAMP combined with Xpert Carba-R in carbapenemase-producing gram-negative bacterial pneumonia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090694
Enrollment
Unknown
Registered
2024-10-11
Start date
2022-07-05
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

pneumonia

Interventions

Gold Standard:Results of drug sensitivity in traditional bacterial culture
Index test:LAMP+Xpert Carba-R

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Source of cases: All patients with clinically diagnosed HAP/VAP. Inclusion criteria: Clinically diagnosed patients with HAP/VAP (which can be combined with infection at other sites), the diagnostic criteria are as follows: Chinese Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia in Adults (2018 edition) The American Society of Infectious Diseases and the American Thoracic Society 2016 Clinical Practice Guidelines for the Management of Hospital-acquired and ventilator-associated Pneumonia in Adults HAP: not in the incubation period of pathogen infection before treatment, pneumonia occurred 48 hours after hospitalization; VAP: Usually refers to the lung infection caused by tracheotomy or intubation after 48 hours of mechanical ventilation treatment in patients who did not originally have a lung infection. Because of the subjectivity and uncertainty of this definition, the actual diagnosis process is usually based on clinical and microbiological criteria. Diagnostic criteria: Chest X-ray or CT showing new or progressive solid shadows, infiltrating shadows, or ground glass shadows with 2 or more of the following: (1) Body temperature >38?; (2) purulent airway secretions; (3) Peripheral blood white blood cell count >10×10^9/L or <4×10^9/L.

Exclusion criteria

Exclusion criteria: (1) Under 18 years of age; (2) AIDS; (3) in the pregnancy or lactation period; (4) Have participated in relevant clinical trials; (5) The patient died or was discharged before the first respiratory specimen culture results were released; (6) Known to be severely allergic to commonly used carbapenem-resistant bacterial infection treatment drugs or have been used for more than 96 hours; (7) Previously there were commonly used carbapenem-resistant bacterial infections to treat drug-induced seizures; (8) Those who have not previously received carbapenem therapy and have been diagnosed with epilepsy requiring antiepileptic therapy Patients are also excluded.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;positive predictive value;negative predictive value;

Secondary

MeasureTime frame
hospital stays;cost;30-day mortality;

Countries

China

Contacts

Public ContactShuyun Xu

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

sxu@hust.edu.cn+86 135 1724 8539

Outcome results

None listed

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