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

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

Detailed Description
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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.

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

Conditions
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Carbapenem Resistant Bacterial Infection, Hemophagocytic Lymphohistiocytoses

Intervention / Treatment
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* Drug: Carrimycin tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carrimycin tablets<br>Carrimycin tablets | Drug: Carrimycin tablets<br>* Carrimycin tablets are administered 400mg a day orally for 7 days.<br>* Other names: Carrimycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rates of infections | The percentage of participants having clinical cure | 1 week and 2 weeks after initiation of treatment | 
| Overall response rate of HLH | Overall response rate includes complete remission (CR) and partial remission (PR) | 2 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | OS will be assessed from initiation of treatment to death from any cause | 1 years | 
| 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 |