Skip to content

Tuberculosis Host Response Xpert-MTB-HR for Predicting Treatment Response: an observational study

Tuberculosis Host Response Xpert-MTB-HR for Predicting Treatment Response: an observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093641
Enrollment
Unknown
Registered
2024-12-09
Start date
2024-09-26
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Tuberculosis

Interventions

Observation group:None

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed untreated symptomatic (cough, weight loss, fever, etc.) patients with pulmonary tuberculosis 2. Be over 18 years of age 3. Able to understand and sign the informed consent form 4. At the same time, one of the adjustments must be met: a) Positive AFB smear - NTM is excluded b) Positive MTB culture, if DST is present, first-line drug resistance is not present c) Xpert MTB/RIF positive with no evidence of rifampicin resistance

Exclusion criteria

Exclusion criteria: 1. Drug susceptibility test (DST) shows resistance to first-line anti-tuberculosis drugs 2. Phenotypic DST does not match Xpert MTB/RIF 3. Anti-TB treatment history in the past year 4. Pregnancy or breastfeeding 5. Tuberculosis combined with extrapulmonary tuberculosis or non-tuberculous mycobacterial lung 6. Combined with hepatic, renal, metabolic, autoimmune diseases, endocrine, hematologic, neurologic diseases, other uncontrolled acute and chronic respiratory diseases. (e.g. AECOPD, asthma), mental illness, malignant tumors, long-term use of immunosuppressive drugs or HIV/AIDS. 7. Alcoholics (>10 years and >2 alcoholic beverages per day). 8. According to the researcher’s judgment, the patient has any diseases that are not suitable for this study or may prevent the patient from participating in the whole study. 9. Concurrent Participants in Other Clinical Studies

Design outcomes

Primary

MeasureTime frame
Treatment success ;Xpert-MTB-HR Value Change Curve;Absorption of lung disease lesions at key time points;

Secondary

MeasureTime frame
Sputum smear conversion status;6m relapse after the end of treatment;12m relapse after the end of treatment;Symptom and Sign Score;

Countries

China

Contacts

Public ContactWei Sha

Shanghai Pulmonary Hospital

850467075@qq.com+86 136 7175 8200

Outcome results

None listed

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