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

Not Applicable

Not yet recruiting

• Conditions: Carbapenem Resistant Bacterial Infection; Hemophagocytic Lymphohistiocytoses
• Interventions: Drug: Carrimycin tablets

• Registration Number: NCT05988177
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-04
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Study Start: 2023-08-30
• Primary Completion: 2026-08-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carrimycin tablets	Carrimycin tablets	Carrimycin tablets

Primary Outcome Measures

Name	Time	Method
Cure rates of infections	1 week and 2 weeks after initiation of treatment	The percentage of participants having clinical cure
Overall response rate of HLH	2 weeks after treatment	Overall response rate includes complete remission (CR) and partial remission (PR)

Secondary Outcome Measures

Name	Time	Method
Overall Survival	1 years	OS will be assessed from initiation of treatment to death from any cause
Incidence and Severity of Adverse Events	28 days	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)

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China