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NCT05624476: PGS-U-UTI&UC
mNGS for Therapy of Urinary Infectious Diseases
trial testing mNGS of urine cell-free DNA in Urinary Tract Infections in 72 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | Shanghai Changzheng Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 72 |
| Start date | 1 January 2023 |
| Primary completion | 30 September 2023 |
| Estimated completion | 31 December 2023 |
Drugs / interventions tested
- mNGS of urine cell-free DNA
Conditions studied
- Urinary Tract Infections — all drugs for Urinary Tract Infections →
- Sequelae of; Infection — all drugs for Sequelae of; Infection →
Sponsor
Shanghai Changzheng Hospital
Who can join
Adults 16 to 70, any sex, with Urinary Tract Infections or Sequelae of; Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05624476
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05624476 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Changzheng Hospital
- Last refreshed: 22 November 2022
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