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Study on the Safety and Effectiveness of Contezoleam in Treating Elderly Patients with Lung Tuberculosis

Efficacy and Safety of Treatment Regimens Containing Contezoleam in Patients Aged 60 and Above with Drug-Sensitive Pulmonary Tuberculosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106183
Enrollment
Unknown
Registered
2025-07-18
Start date
2025-07-30
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Pulmonary tuberculosis

Interventions

Experimental Group (Contezoleam Group):HREC (Isoniazid, Rifampicin, Ethambutol, Contezoleam)
Control Group (Pyrazinamide Group):HREZ (Isoniazid, Rifampicin, Ethambutol, Pyrazinamide)

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age between 60 and 85 years, regardless of gender; 2.Diagnosed with pulmonary tuberculosis confirmed by WHO bacteriological criteria, with no evidence of resistance to first-line anti-tuberculosis drugs (at least confirmed sensitivity to rifampicin); 3.No prior anti-tuberculosis treatment before enrollment, or exposure to anti-tuberculosis drugs for less than one week; 4.Able to understand and sign the informed consent form, comply with medication, testing, and follow-up during the study, and promptly report adverse events.

Exclusion criteria

Exclusion criteria: 1.Allergy to any of the anti-tuberculosis drugs used in the study regimen or a history of allergy to such drugs; 2.Participation in any other clinical trial (in vivo) within the past three months; 3.Co-infection with non-tuberculous mycobacteria; 4.Other conditions deemed by the investigator as unsuitable for participation in this trial (including any situation where first-line treatment is not appropriate).

Design outcomes

Primary

MeasureTime frame
Treatment Success Rate;

Secondary

MeasureTime frame
Microbiological conversion rate, incidence of adverse events, and rate of acquired drug resistance;Adverse events;

Countries

China

Contacts

Public ContactXia Lu

Shanghai Public Health Clinical Center

xialu@shphc.org.cn+86 18121155957

Outcome results

None listed

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