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

Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05988177
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
40
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Carrimycin tablets
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study on the Efficacy and Safety of Carrimycin Tablets in Hemophagocytic Lymphohistiocytosis Patients With Carbapenem-resistant Infections
Anticipated Study Start Date :
Aug 30, 2023
Anticipated Primary Completion Date :
Aug 30, 2026
Anticipated Study Completion Date :
Dec 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carrimycin tablets

Carrimycin tablets

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cure rates of infections [1 week and 2 weeks after initiation of treatment]

      The percentage of participants having clinical cure

    2. Overall response rate of HLH [2 weeks after treatment]

      Overall response rate includes complete remission (CR) and partial remission (PR)

    Secondary Outcome Measures

    1. Overall Survival [1 years]

      OS will be assessed from initiation of treatment to death from any cause

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050

    Sponsors and Collaborators

    • Beijing Friendship Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhao Wang, Professor and Head of hematology, Beijing Friendship Hospital
    ClinicalTrials.gov Identifier:
    NCT05988177
    Other Study ID Numbers:
    • BFH20230522002
    First Posted:
    Aug 14, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Bacterial Infections
    Lymphohistiocytosis, Hemophagocytic
    Spiramycin

    Study Results

    No Results Posted as of Aug 14, 2023