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Clinical study of contezolid tablets in the treatment of bloodstream infection caused by gram-positive bacteria in patients with febrile neutropenia

Clinical study on the efficacy and safety of contezolid tablets in the treatment of bloodstream infection caused by gram-positive bacteria in patients with febrile neutropenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066186
Enrollment
Unknown
Registered
2022-11-27
Start date
2022-11-30
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

bloodstream infection

Interventions

intervention group:contezolid tablets

Sponsors

Ethics Committee of Blood Diseases Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female aged >= 18 years; 2. Conform to the diagnostic criteria of febrile neutropenia, clinical diagnosis of blood stream infection (BSI) and etiological diagnosis criteria, and confirm the blood stream infection of gram-positive bacteria, and the infection of other parts with or without it (such as pneumonia or skin and soft tissue infection); 3. Subjects (or their legal representatives/guardians) understand the steps and contents of the study, sign the informed consent form, and are willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic tocontezolid tablets or have severe allergic constitution (such as allergic dermatitis and bronchial asthma); 2. Those who cannot be administered orally or are not suitable for administration through nasal feeding/gastrointestinal nutrition tube, or have gastrointestinal diseases that will seriously affect the absorption of oral drugs; 3. Expected survival time3 times, or alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >= 5 times the upper limit of normal value [ULN]; 5. CrCl = 500 msec); 7. In the first month before enrollment, he has received the intervention clinical research of other drugs or medical devices; 8. The investigator believes that it is not suitable to participate in this clinical study or have influence on the endpoint evaluation due to various reasons.

Design outcomes

Primary

MeasureTime frame
efficacy;

Secondary

MeasureTime frame
pharmacokinetic characteristics;safety;

Countries

China

Contacts

Public ContactSizhou Feng

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, China

szfeng@ihcams.ac.cn+86 22 2390 9162

Outcome results

None listed

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