Individualized treatment of high-risk drug-resistant population based on whole genome sequencing

Efficacy and safety of individualized treatment for drug-resistant high-risk populations based on whole genome sequencing: prospective, randomized, cohort study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037423

Enrollment

Unknown

Registered

2020-08-28

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Multidrug resistant tuberculosis

Interventions

Case series:individualized treatment based on whole-genome sequencing

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: A tuberculosis patient with a definite diagnosis who meets the following criteria: (1) recurrence; (2) Irregular anti-tuberculosis treatment for more than 1 month; (3) Anti-tb treatment in late February sputum smear positive; (4) The first administration fails; (5) Repeated anti-tuberculosis treatment; (6) Smear positive patients in drug-resistant TB endemic areas; (7) Clear exposure history of mDR-resistant patients.

Exclusion criteria

Exclusion criteria: (1) Unable to sign informed consent; (2) Prior to the program of anti-tuberculosis drug allergy history can not constitute an effective anti-tuberculosis program; (3) samples cannot be obtained for culture; (4) treatment compliance can not be poor collaborators; (5) Participants in other clinical trials in the last three months; (6) Severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases; (7) Pregnant or lactating women or women of childbearing age who are preparing for conception.

Design outcomes

Primary

Measure	Time frame
effect and safety;	—

Contacts

Public ContactXiaohui Hao

Shanghai Pulmonary Hospital

xh-h@163.com+86 18964521445

Outcome results

None listed

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