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

ConditionsCarbapenem Resistant Bacterial InfectionHemophagocytic Lymphohistiocytoses
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Friendship Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Met HLH-2004 diagnostic criteria;

Active infection；

Empirical treatment with carbapenems did not respond after 72 hours；

Age >18 years old, no gender limitation;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Carrimycin tablets

    Drug

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Carrimycin tabletsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cure rates of infections

The percentage of participants having clinical cure

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

Overall response rate of HLH

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

Time frame
2 weeks after treatment

Secondary outcomes

1

Overall Survival

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

Time frame
1 years
2

Incidence and Severity of Adverse Events

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)

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: