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

NCT ID: NCT05988177

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-12-30

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.

Conditions

Carbapenem Resistant Bacterial Infection; Hemophagocytic Lymphohistiocytoses

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carrimycin tablets

Carrimycin tablets

Group Type: EXPERIMENTAL

Carrimycin tablets

Intervention Type: DRUG

Carrimycin tablets are administered 400mg a day orally for 7 days.

Interventions

Carrimycin tablets

Carrimycin tablets are administered 400mg a day orally for 7 days.

Intervention Type: DRUG

Other Intervention Names

Carrimycin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Professor and Head of hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhao Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Zhao Wang, MD

Role: CONTACT

wangzhao@ccmu.edu.cn

63138303

Facility Contacts

Zhao Wang, MD

Role: primary

wangzhao@ccmu.edu.cn

63138303

Other Identifiers

BFH20230522002

Identifier Type: -

Identifier Source: org_study_id