Status:
NOT_YET_RECRUITING
Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Carbapenem Resistant Bacterial Infection
Hemophagocytic Lymphohistiocytoses
Eligibility:
All Genders
18+ years
Phase:
NA
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 secreti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05988177
Start Date
August 30 2023
End Date
December 30 2026
Last Update
August 14 2023
Active Locations (1)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050