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

NCT05988177 | Not Yet Recruiting

• 1 other identifier: BFH20230522002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Cure rates of infections

  The percentage of participants having clinical cure

  1 week and 2 weeks after initiation of treatment

• Overall response rate of HLH

  Overall response rate includes complete remission (CR) and partial remission (PR)

  2 weeks after treatment

Secondary Outcomes (2)

• Overall Survival

  1 years

• Incidence and Severity of Adverse Events

  28 days

Study Arms (1)

Carrimycin tablets

EXPERIMENTAL

Carrimycin tablets

Drug: Carrimycin tablets

Interventions

Carrimycin tablets DRUG

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

Also known as: Carrimycin

Carrimycin tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

carrimycin

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zhao Wang, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhao Wang, MD

CONTACT

63138303; wangzhao@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of hematology

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)