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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hemophagocytic Lymphohistiocytoses; Carbapenem Resistant Bacterial Infection
• Intervention / Treatment: Drug: Carrimycin tablets

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhao Wang, MD; Phone Number: 63138303; Email: wangzhao@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Zhao Wang, MD; Phone Number: 63138303; Email: wangzhao@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carrimycin tablets	Drug: Carrimycin tablets; Carrimycin tablets are administered 400mg a day orally for 7 days.; Other Names: Carrimycin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Zhao Wang, MD, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Disease Attributes; Bacterial Infections and Mycoses; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Infections; Communicable Diseases; Bacterial Infections; Lymphohistiocytosis, Hemophagocytic; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Spiramycin
• Other Study ID Numbers: BFH20230522002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No