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Clinical trial

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

ID
Name
BFH20230522002
Description
This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.
Trial arms
Trial start
2023-08-30
Estimated PCD
2026-08-30
Trial end
2026-12-30
Status
Not yet recruiting
Treatment
Carrimycin tablets
Carrimycin tablets are administered 400mg a day orally for 7 days.
Arms:
Carrimycin tablets
Other names:
Carrimycin
Size
20
Primary endpoint
Cure rates of infections
1 week and 2 weeks after initiation of treatment
Overall response rate of HLH
2 weeks after treatment
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-08-14

1 organization

1 product

2 indications

Organization
Beijing Friendship Hospital
Product
Carrimycin
Indication
Carbapenem Resistant Bacterial Infection
Indication
Hemophagocytic Lymphohistiocytoses