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Not yet recruiting NCT05988177

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

No phase Interventional Carbapenem Resistant Bacterial Infection Hemophagocytic Lymphohistiocytoses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carrimycin tablets.
Who it may be relevant to
Registry conditions: Carbapenem Resistant Bacterial Infection, Hemophagocytic Lymphohistiocytoses. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Primary outcome measures

  • Cure rates of infections [Time frame: 1 week and 2 weeks after initiation of treatment]
  • Overall response rate of HLH [Time frame: 2 weeks after treatment]
Secondary outcome measures (2)
  • Overall Survival [Time frame: 1 years]
  • Incidence and Severity of Adverse Events [Time frame: 28 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Friendship Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT05988177 · BFH20230522002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗