Skip to content

Based on the pharmacokinetics study of contezolamide in Rifampicin resistant tuberculosis patients

Based on the pharmacokinetics study of contezolamide in Rifampicin resistant tuberculosis patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074234
Enrollment
Unknown
Registered
2023-08-01
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

Drug-resistant tuberculosis

Interventions

Experimental group:Treatment of rifampicin-resistant pulmonary tuberculosis with a regimen containing contezolamide
Linezolid control group:A regimen containing linezolid for the treatment of rifampicin-resistant tuberculosis

Sponsors

Beijing Chest Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: Age of subjects: 18 years old =65 years old, male or female 2: Subject weight: 40kg= 90kg 3: Rifampicin resistance (RR-TB) was diagnosed by molecular biology 4: The sputum smear was positive for acid-fast bacilli (AFB at least 1+) 5: HIV test negative 6: For non-lactating and pregnant women, consent to continue using contraception throughout the treatment 7: Fully understand the purpose and requirements of this experiment, voluntarily sign the written informed consent and agree to abide by the requirements and restrictions set forth in the informed consent and Agreement

Exclusion criteria

Exclusion criteria: 1: Drug sensitivity results show that there is a history of resistance to the drug in the regimen or allergy to any of the ingredients in the regimen, or are taking any drug that is contraindicated with the drug in the regimen 2: Severe renal and liver insufficiency 3: Unable to attend or comply with treatment and follow-up 4: QTcF interval > 500 ms 5: Have a history of or are suffering from cardiovascular diseases such as heart failure, hypertension (poorly controlled blood pressure), arrhythmia or post-myocardial infarction status 6: Pregnant or lactating women 7: HIV positive or AIDS patients.

Design outcomes

Primary

MeasureTime frame
Adverse event;

Secondary

MeasureTime frame
Efficacy index;

Countries

China

Contacts

Public ContactWang Jun/ Chu Naihui

Beijing Chest Hospital affiliated to Capital Medical University

wangjunzt@126.com+86 135 5212 1945

Outcome results

None listed

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