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The application of new technology Nanodisk-MS to the diagnosis and treatment monitoring of bone and joint tuberculosis in a prospective cohort study

The application of new technology Nanodisk-MS to the diagnosis and treatment monitoring of bone and joint tuberculosis in a prospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDD-17013207
Enrollment
Unknown
Registered
2017-11-01
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-11-06

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

Conditions

bone and joint tuberculosis

Interventions

Gold Standard:Culture of tuberculosis
diagnostic antituberculosis treatment
MTB/RIF

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Diagnostic group inclusion criteria: 1. meet one of the following four points: (1) clinical symptoms / signs consistent with tuberculosis changes, while imaging evidence consistent consistent with suspicious tuberculosis; (2) imaging evidence consistent with suspicious tuberculosis, with positive hospital tuberculosis related laboratory indications and not yet treated; (3) imaging evidence consistent with suspicious tuberculosis, previous history of tuberculosis or recent tuberculosis exposure history; (4) clinical symptoms consistent with tuberculosis changes, imaging evidence is not typical, but clinical highly suspicious. (Suspicious tuberculosis standards clinical symptoms / signs, imaging evidence, laboratory checklist see attached table.) 2. T-SPOT positive or T-SPOT negative but satisfies the following conditions: (1) Aged <5 years; (2) immunodeficiency patients, such as HIV patients; (3) history of immunosuppressive agents; (4) history of hormone drugs; (5) Patients with chronic renal failure; (6) Diabetic patients; (7) still clinical highly skeptical; 3. The patient or family member signs the informed consent. Treatment monitoring group inclusion criteria: 1. meet one of the following three: (1) Not meet the diagnostic criteria of the group, but the evidence of tuberculosis has been clear, need anti-TB treatment; (2) Not meet the diagnostic criteria of the group, but with postive response of anti-TB treatment; (3) Diagnostic group patients and need anti-TB treatment. 2. The patient or family member signs the informed consent.;Inclusion criteria: Diagnostic group inclusion criteria: 1. meet one of the following four points: (1) clinical symptoms / signs consistent with tuberculosis changes, while imaging evidence consistent consistent with suspicious tuberculosis; (2) imaging evidence consistent with suspicious tuberculosis, with positive hospital tuberculosis related laboratory indications and not yet treated; (3) imaging evidence consistent with suspicious tuberculosis, previous history of tuberculosis or recent tuberculosis exposure history; (4) clinical symptoms consistent with tuberculosis changes, imaging evidence is not typical, but clinical highly suspicious. (Suspicious tuberculosis standards clinical symptoms / signs, imaging evidence, laboratory checklist see attached table.) 2. T-SPOT positive or T-SPOT negative but satisfies the following conditions: (1) Aged <5 years; (2) immunodeficiency patients, such as HIV patients; (3) history of immunosuppressive agents; (4) history of hormone drugs; (5) Patients with chronic renal failure; (6) Diabetic patients; (7) still clinical highly skeptical; 3. The patient or family member signs the informed consent. Treatment monitoring group inclusion criteria: 1. meet one of the following three: (1) Not meet the diagnostic criteria of the group, but the evidence of tuberculosis has been clear, need anti-TB treatment; (2) Not meet the diagnostic criteria of the group, but with postive response of anti-TB treatment; (3) Diagnostic group patients and need anti-TB treatment. 2. The patient or family member signs the informed consent.;Inclusion criteria: Diagnostic group inclusion criteria: 1. meet one of the following four points: (1) clinical symptoms / signs consistent with tuberculosis changes, while imaging evidence consistent consistent with suspicious tuberculosis; (2) imaging evidence consistent with suspicious tuberculosis, with positive hospital tuberculosis related laboratory indications and not yet treated; (3) imaging evidence consistent with suspicious tuberculosis, previous history of tuberculosis or recent tuberculosis exposure history; (4) clinical symptoms consistent with tuberculosis changes, imaging evidence is not typical, but clinical highly suspicious. (Suspicious tuberculosis standards clinical symptoms / signs, imaging evidence, laboratory checklist see attached table.) 2. T-SPOT positive or T-SPOT negative but satisfies the following conditions: (1) Aged <5 years; (2) immunodeficiency patients, such as HIV patients; (3) history of immunosuppressive agents; (4) history of hormone drugs; (5) Patients with chronic renal failure; (6) Diabetic patients; (7) still clinical highly skeptical; 3. The patient or family member signs the informed consent. Treatment monitoring group inclusion criteria: 1. meet one of the following three: (1) Not meet the diagnostic criteria of the group, but the evidence of tuberculosis has been clear, need anti-TB treatment; (2) Not meet the diagnostic criteria of the group, but with postive response of anti-TB treatment; (3) Diagnostic group patients and need anti-TB treatment. 2. The patient or family member signs the informed consent.;Inclusion criteria: Diagnostic group inclusion criteria: 1. meet one of the following four points: (1) clinical symptoms / signs consistent with tuberculosis changes, while imaging evidence consistent consistent with suspicious tuberculosis; (2) imaging evidence consistent with suspicious tuberculosis, with positive hospital tuberculosis related laboratory indications and not yet treated; (3) imaging evidence consistent with suspicious tuberculosis, previous history of tuberculosis or recent tuberculosis exposure history; (4) clinical symptoms consistent with tuberculosis changes, imaging evidence is not typical, but clinical highly suspicious. (Suspicious tuberculosis standards clinical symptoms / signs, imaging evidence, laboratory checklist see attached table.) 2. T-SPOT positive or T-SPOT negative but satisfies the following conditions: (1) Aged <5 years; (2) immunodeficiency patients, such as HIV patients; (3) history of immunosuppressive agents; (4) history of hormone drugs; (5) Patients with chronic renal failure; (6) Diabetic patients; (7) still clinical highly skeptical; 3. The patient or family member signs the informed consent. Treatment monitoring group inclusion criteria: 1. meet one of the following three: (1) Not meet the diagnostic criteria of the group, but the evidence of tuberculosis has been clear, need anti-TB treatment; (2) Not meet the diagnostic criteria of the group, but with postive response of anti-TB treatment; (3) Diagnostic group patients and need anti-TB treatment. 2. The patient or family member signs the informed consent.;Inclusion criteria: Diagnostic group inclusion criteria: 1. meet one of the following four points: (1) clinical symptoms / signs consistent with tuberculosis changes, while imaging evidence consistent consistent with suspicious tuberculosis; (2) imaging evidence consistent with suspicious tuberculosis, with positive hospital tuberculosis related laboratory indications and not yet treated; (3) imaging evidence consistent with suspicious tuberculosis, previous history of tuberculosis or recent tuberculosis exposure history; (4) clinical symptoms consistent with tuberculosis changes, imaging evidence is not typical, but clinical highly suspicious. (Suspicious tuberculosis standards clinical symptoms / signs, imaging evidence, laboratory checklist see attached table.) 2. T-SPOT positive or T-SPOT negative but satisfies the following conditions: (1) Aged <5 years; (2) immunodeficiency patients, such as HIV patients; (3) history of immunosuppressive agents; (4) history of hormone drugs; (5) Patients with chronic renal failure; (6) Diabetic patients; (7) still clinical highly skeptical; 3. The patient or family member signs the informed consent. Treatment monitoring group inclusion criteria: 1. meet one of the following three: (1) Not meet the diagnostic criteria of the group, but the evidence of tuberculosis has been clear, need anti-TB treatment; (2) Not meet the diagnostic criteria of the group, but with postive response of anti-TB treatment; (3) Diagnostic group patients and need anti-TB treatment. 2. The patient or family member signs the informed consent.

Exclusion criteria

Exclusion criteria: Diagnostic group exclusion criteria: 1. the use of fluoroquinolones antibiotics recently (6 months or less); 2. recent (within 6 months) conducted regular anti-TB treatment, and the treatment is effective, or difficult to assess the efficacy, or spinal anti-TB treatment more than 9 days; 3. T-SPOT can not be returned before the group, according to the evidence has been proved to be other diseases. Treatment monitoring group exclusion criteria: 1. recent (within 6 months) anti-tuberculosis treatment, and the treatment is effective, or the effect is difficult to assess; 2. recent (6 months or less) have had major liver disease, or severe liver dysfunction; 3. Patients have been identified liver and kidney dysfunction or drug allergy can not tolerate drug treatment; 4. Patients who refuse medication;;Exclusion criteria: Diagnostic group exclusion criteria: 1. the use of fluoroquinolones antibiotics recently (6 months or less); 2. recent (within 6 months) conducted regular anti-TB treatment, and the treatment is effective, or difficult to assess the efficacy, or spinal anti-TB treatment more than 9 days; 3. T-SPOT can not be returned before the group, according to the evidence has been proved to be other diseases. Treatment monitoring group exclusion criteria: 1. recent (within 6 months) anti-tuberculosis treatment, and the treatment is effective, or the effect is difficult to assess; 2. recent (6 months or less) have had major liver disease, or severe liver dysfunction; 3. Patients have been identified liver and kidney dysfunction or drug allergy can not tolerate drug treatment; 4. Patients who refuse medication;;Exclusion criteria: Diagnostic group exclusion criteria: 1. the use of fluoroquinolones antibiotics recently (6 months or less); 2. recent (within 6 months) conducted regular anti-TB treatment, and the treatment is effective, or difficult to assess the efficacy, or spinal anti-TB treatment more than 9 days; 3. T-SPOT can not be returned before the group, according to the evidence has been proved to be other diseases. Treatment monitoring group exclusion criteria: 1. recent (within 6 months) anti-tuberculosis treatment, and the treatment is effective, or the effect is difficult to assess; 2. recent (6 months or less) have had major liver disease, or severe liver dysfunction; 3. Patients have been identified liver and kidney dysfunction or drug allergy can not tolerate drug treatment; 4. Patients who refuse medication;;Exclusion criteria: Diagnostic group exclusion criteria: 1. the use of fluoroquinolones antibiotics recently (6 months or less); 2. recent (within 6 months) conducted regular anti-TB treatment, and the treatment is effective, or difficult to assess the efficacy, or spinal anti-TB treatment more than 9 days; 3. T-SPOT can not be returned before the group, according to the evidence has been proved to be other diseases. Treatment monitoring group exclusion criteria: 1. recent (within 6 months) anti-tuberculosis treatment, and the treatment is effective, or the effect is difficult to assess; 2. recent (6 months or less) have had major liver disease, or severe liver dysfunction; 3. Patients have been identified liver and kidney dysfunction or drug allergy can not tolerate drug treatment; 4. Patients who refuse medication;;Exclusion criteria: Diagnostic group exclusion criteria: 1. the use of fluoroquinolones antibiotics recently (6 months or less); 2. recent (within 6 months) conducted regular anti-TB treatment, and the treatment is effective, or difficult to assess the efficacy, or spinal anti-TB treatment more than 9 days; 3. T-SPOT can not be returned before the group, according to the evidence has been proved to be other diseases. Treatment monitoring group exclusion criteria: 1. recent (within 6 months) anti-tuberculosis treatment, and the treatment is effective, or the effect is difficult to assess; 2. recent (6 months or less) have had major liver disease, or severe liver dysfunction; 3. Patients have been identified liver and kidney dysfunction or drug allergy can not tolerate drug treatment; 4. Patients who refuse medication;

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specitivity;

Countries

China

Contacts

Public ContactSun Ziyong, Li Feng;Sun Ziyong, Li Feng;Sun Ziyong, Li Feng;Sun Ziyong, Li Feng;Sun Ziyong, Li Feng ;;;;

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

tjszyong@163.com;tjszyong@163.com;tjszyong@163.com;tjszyong@163.com;tjszyong@163.com+86 13627223457,027-83665219;+86 13627223457,027-83665219;+86 13627223457,027-83665219;+86 136272234

Outcome results

None listed

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