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NCT05624476
mNGS for Therapy of Urinary Infectious Diseases
Conditions: Urinary Tract Infections, Sequelae of; Infection
Sex: All
Ages: 16 Years – 70 Years
Enrollment: 72
Sponsor: Shanghai Changzheng Hospital
Summary
Urinary tract infection is a common infectious disease in clinic.
Although urinary tract infection can be initially diagnosed by clinical sign and symptom, signs and urine routine, the application of appropriate antibiotic therapy depends on the further identification of pathogens.Metagenomic sequencing has been widely used in clinical pathogen diagnosis, especially in difficult infectious diseases.
ICompared with tissue samples, cerebrospinal fluid, bronchoalveolar lavage fluid, whole blood and other samples, the application of mNGS in urine samples is relatively limited because incorrect sampling methods before and after collection of urine samples are easy to contaminate the samples and the colonization of distal urethra, periurethral skin and vagina will interfere with the interpretation of reports.Previous small sample studies have shown that the sensitivity of mNGS in urinary tract infection is high, but the specificity is relatively low, and there are many problems such as difficult interpretation of reports and low clinical conformity.
This is closely related to the mNGS technology algorithm, such as the inability to eliminate the influence of urinary system background bacteria, and the ambiguity of short sequence alignment, which makes it difficult to distinguish homologous pathogens.In this study, based on the standard mNGS sequencing process, the improved Z value analysis method was used to select strictly enrolled clinical samples and compare them with pathogen culture to observe the clinical value of mNGS with Z value analysis method in the treatment of urinary tract infection.
Eligibility Criteria
Inclusion Criteria:Age: 16-70 years.Typical symptoms of urinary tract infection + pyuria (WBC ≥ 10/HP in urine sediment after centrifugation).Clinical diagnosis: acute cystitis, urethritis, acute and chronic prostatitis, pyelonephritis, epididymitis; or complex urinary tract infection, such as urinary tract deformity, obstruction, double J tube, etc.Sign the informed consent form voluntarily.Exclusion Criteria:Malignant tumors of liver or other organs or previous history of tumors.Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute infection.Patients with severe heart, lung, kidney or blood system diseases and failure.Pregnant or breastfeeding women.Allergic constitution.Those who have a history of alcoholism and drug abuse and fail to give up effectively.The subject withdrew from the study on the condition that he/she had not participated in other clinical trials within 4 weeks.Other conditions which, in the opinion of the investigator, are not suitable for participation in the study.Antibiotic therapy was performed in the past month because of urinary tract infection.Broad-spectrum antibiotic therapy has been performed for other uncontrollable infections or other infections.
Source: ClinicalTrials.gov (NCT05624476). StuddyBuddy aggregates publicly available trial information.