Not yet recruitingNCT05988177Updated Aug 14, 2023

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

An interventional study of Carrimycin tablets in Carbapenem Resistant Bacterial Infection and Hemophagocytic Lymphohistiocytoses, sponsored by Beijing Friendship Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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 studied

Carbapenem Resistant Bacterial Infection
Hemophagocytic Lymphohistiocytoses

Browse trials for

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
Carrimycin tablets
Carrimycin tablets
Drug: Carrimycin tablets

Interventions

DrugCarrimycin tablets
Carrimycin tablets are administered 400mg a day orally for 7 days.
Also known as: Carrimycin

What researchers measure

Primary outcomes

Cure rates of infections
The percentage of participants having clinical cure
Time frame: 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)
Time frame: 2 weeks after treatment

Secondary outcomes

Overall Survival
OS will be assessed from initiation of treatment to death from any cause
Time frame: 1 years
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

Study locations

1 site

Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100050, China
- Zhao Wang, MD · Contact · wangzhao@ccmu.edu.cn · 63138303

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05988177
Lead sponsor: Beijing Friendship Hospital
Responsible party: Zhao Wang (Professor and Head of hematology, Beijing Friendship Hospital) — Principal investigator
First posted: Aug 14, 2023
Start date: Aug 30, 2023 (estimated)
Primary completion: Aug 30, 2026 (estimated)
Completion: Dec 30, 2026 (estimated)
Last update: Aug 14, 2023

Study contacts

Zhao Wang, MD

Contact

wangzhao@ccmu.edu.cn

63138303

Zhao Wang, MD

principal investigator · Beijing Friendship Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Beijing Friendship Hospital

Start the discussion