ClinicalTrials.gov record NCT05988177

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.The registry record was last updated on Aug 14, 2023, about 3 years ago, so the status shown may be out of date. The study team or the registry can confirm.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age18 years old and older

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study investigates the efficacy and safety of oral Carrimycin in adults with HLH who have carbapenem-resistant infections. Participants receive 400 mg of Carrimycin once daily by mouth for 7 days. The study is single-group and open-label, and it records infection cure, HLH response, survival, and side effects.

What it is studying. The study is testing whether oral Carrimycin tablets are effective and safe for treating carbapenem-resistant bacterial infections in people with hemophagocytic lymphohistiocytosis (HLH). Key measures are infection cure rates at 1 and 2 weeks, overall HLH response at 2 weeks (complete or partial remission), overall survival up to 1 year, and incidence/severity of treatment-related adverse events (assessed up to 28 days).

What the researchers hope to learn. To collect data on the efficacy (infection cure rates and HLH response) and safety (type and severity of adverse events) of Carrimycin in HLH patients with carbapenem-resistant infections, and to measure overall survival over one year.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Carrimycin tablets

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take Carrimycin tablets orally, 400 mg once daily for 7 days. They will attend follow-up visits to assess infection cure (at 1 and 2 weeks) and HLH response (at 2 weeks), have clinical assessments and safety monitoring, and have adverse events recorded for 28 days. Overall survival will be tracked up to 1 year.

How the study is structured. All participants receive the same treatment (Carrimycin tablets 400 mg daily for 7 days). The study is single-group and not masked (open-label). Researchers assess infection status and HLH response at 1–2 weeks, record side effects for about 28 days, and follow survival for up to 1 year.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on hemophagocytic lymphohistiocytosis

Clinical trials34 trials listed for hemophagocytic lymphohistiocytosisEvery trial the registry lists for hemophagocytic lymphohistiocytosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hemophagocytic lymphohistiocytosis researchLatest monthly update: September 2026. Includes: Multiple test results. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Aug 30, 2023 (estimated)
Primary completion: Aug 30, 2026 (estimated)
Study completion: Dec 30, 2026 (estimated)
Target enrollment: 20 participants (estimated)
Last updated on registry: Aug 14, 2023
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Beijing Friendship Hospital
Principal investigator: Zhao Wang, Professor and Head of hematology
Beijing Friendship Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Zhao Wang, MD 📞 63138303 ✉ wangzhao@ccmu.edu.cn

Participating sites (1)

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

Terms used on this page · explanations by MedicalUpdates.ai

contraindications: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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