Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05988177

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

This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location contact

Zhao Wang, MD

CONTACT

[email protected]

63138303

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carrimycin tablets

Drug

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

Other names: Carrimycin

Primary outcomes

  1. Cure rates of infections

    Time frame: 1 week and 2 weeks after initiation of treatment

    The percentage of participants having clinical cure

  2. Overall response rate of HLH

    Time frame: 2 weeks after treatment

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

Secondary outcomes

  1. Overall Survival

    Time frame: 1 years

    OS will be assessed from initiation of treatment to death from any cause

  2. Incidence and Severity of Adverse Events

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Zhao Wang, MD

CONTACT

[email protected]

63138303

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.