Carbapenem Resistant Bacterial Infection, Hemophagocytic Lymphohistiocytoses
Conditions
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.
Interventions
DRUGCarrimycin tablets
Carrimycin tablets are administered 400mg a day orally for 7 days.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rates of infections | 1 week and 2 weeks after initiation of treatment | The percentage of participants having clinical cure |
| Overall response rate of HLH | 2 weeks after treatment | Overall response rate includes complete remission (CR) and partial remission (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 1 years | OS will be assessed from initiation of treatment to death from any cause |
| 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) |
Countries
China
Contacts
Primary ContactZhao Wang, MD
Outcome results
None listed