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Application value of microneedle technique in diagnosis of tuberculosis

Application value of microneedle technique in diagnosis of tuberculosis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039645
Enrollment
Unknown
Registered
2020-11-04
Start date
2020-11-02
Completion date
Unknown
Last updated
2021-02-08

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

Conditions

Tuberculosis

Interventions

Gold Standard:Tuberculosis culture
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Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Volunteers voluntarily agreed to participate in this study, aged 18-65 years old. Participants should know their BCG immunity and whether they have tuberculosis infection or history. 2. Active tuberculosis infection group: with clinical symptoms of tuberculosis (cough >= 2 weeks, continuous fever, night sweats, weight loss, etc.), excluding other pulmonary diseases, and meeting one of the following diagnostic criteria: (1) PPD was strongly positive; (2) The pathogen test was positive; (3) Imaging diagnosis: common X-ray film, CT, MRI or ultrasound suggested that active tuberculosis might occur; (4) Tuberculosis was diagnosed by pathological tissue or molecular pathology; 3. Latent infection tuberculosis group: no clinical symptoms of tuberculosis, and meet the following diagnostic criteria: (1) PPD >= 5mm; (2) IFN - ? release test (IGRAs) was positive; (3) The pathogen test was negative; (4) Imaging diagnosis: X-ray, CT, MRI or ultrasound showed that tuberculosis was negative; 4. Control group: BCG immunized people and healthy people with negative IGRAs test.

Exclusion criteria

Exclusion criteria: 1. Patients who have recently received antituberculosis treatment take anticoagulants or have coagulation dysfunction; 2. Patients with primary or secondary immunodeficiency, including HIV, long-term steroid use and patients with autoimmune diseases; 3. Patients with malignant tumor, language dysfunction, mental system disease and other serious diseases; 4. Patients participating in other clinical trials; 5. Patients who are considered unsuitable for clinical trials for other reasons by researchers.

Design outcomes

Primary

MeasureTime frame
the redness and induration of the skin and duration time;

Countries

China

Contacts

Public ContactWei Wang

Shenzhen Second People's Hospital

wwangsz78@sina.com+86 13510224282

Outcome results

None listed

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