Back to resultsEfficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections
Primary Purpose
Carbapenem Resistant Bacterial Infection, Hemophagocytic Lymphohistiocytoses
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Carrimycin tablets
Sponsored by
About this trial
This is an interventional treatment trial for Carbapenem Resistant Bacterial Infection
Eligibility Criteria
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.
Sites / Locations
- Beijing Friendship Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Carrimycin tablets
Arm Description
Carrimycin tablets
Outcomes
Primary Outcome Measures
Cure rates of infections
The percentage of participants having clinical cure
Overall response rate of HLH
Overall response rate includes complete remission (CR) and partial remission (PR)
Secondary Outcome Measures
Overall Survival
OS will be assessed from initiation of treatment to death from any cause
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)
Full Information
NCT ID
NCT05988177
First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05988177
Brief Title
Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections
Official Title
Clinical Study on the Efficacy and Safety of Carrimycin Tablets in Hemophagocytic Lymphohistiocytosis Patients With Carbapenem-resistant Infections
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
August 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbapenem Resistant Bacterial Infection, Hemophagocytic Lymphohistiocytoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carrimycin tablets
Arm Type
Experimental
Arm Description
Carrimycin tablets
Intervention Type
Drug
Intervention Name(s)
Carrimycin tablets
Other Intervention Name(s)
Carrimycin
Intervention Description
Carrimycin tablets are administered 400mg a day orally for 7 days.
Primary Outcome Measure Information:
Title
Cure rates of infections
Description
The percentage of participants having clinical cure
Time Frame
1 week and 2 weeks after initiation of treatment
Title
Overall response rate of HLH
Description
Overall response rate includes complete remission (CR) and partial remission (PR)
Time Frame
2 weeks after treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Description
OS will be assessed from initiation of treatment to death from any cause
Time Frame
1 years
Title
Incidence and Severity of Adverse Events
Description
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)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Wang, MD
Phone
63138303
Email
wangzhao@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Wang, MD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Wang, MD
Phone
63138303
Email
wangzhao@ccmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections
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