Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections

Hemophagocytic Lymphohistiocytoses Clinical Trial

Official title:

Clinical Study on the Efficacy and Safety of Carrimycin Tablets in Hemophagocytic Lymphohistiocytosis Patients With Carbapenem-resistant Infections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05988177
• Other study ID #: BFH20230522002
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: August 2023
• Source: Beijing Friendship Hospital
• Contact: Zhao Wang, MD
• Phone: 63138303
• Email: wangzhao[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.

Description:

Hemophagocytic lymphohistiocytosis (HLH) is a critical condition characterized by the undue activation of cytotoxic T lymphocytes, natural killer cells, and macrophages, resulting in excessive secretion of infammatory cytokines. Infection is an important trigger for HLH. This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Met HLH-2004 diagnostic criteria;
• Active infection;
• Empirical treatment with carbapenems did not respond after 72 hours;
• Age >18 years old, no gender limitation;
• Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

• Other antibiotics should be selected according to the results of drug sensitivity;
• Systemic antibiotics other than carbapenems are used with 72 hours;
• Inability to take oral medications due to disease of gastrointestinal tract;
• Severe liver insufficiency;
• Expected survival time < 1 month;
• Pregnant or breasting-feeding women;
• Allergic to Carrimycin tablets;
• Active hepatitis B or hepatitis C infection;
• Patients with HIV infection;
• Patients with other contraindications considered unsuitable for participation in this study.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Hemophagocytic Lymphohistiocytoses
• Infections
• Lymphohistiocytosis, Hemophagocytic

Intervention

Drug:
• Carrimycin tablets
Carrimycin tablets are administered 400mg a day orally for 7 days.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rates of infections	The percentage of participants having clinical cure	1 week and 2 weeks after initiation of treatment
Primary	Overall response rate of HLH	Overall response rate includes complete remission (CR) and partial remission (PR)	2 weeks after treatment
Secondary	Overall Survival	OS will be assessed from initiation of treatment to death from any cause	1 years
Secondary	Incidence and Severity of Adverse Events	Treatment-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)	28 days