Carbapenem Resistant Bacterial InfectionNCT05988177
Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections
A study testing Carrimycin tablets in people with Carbapenem Resistant Bacterial Infection and Hemophagocytic Lymphohistiocytoses, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenem Resistant Bacterial Infection, Hemophagocytic Lymphohistiocytoses
- What is being tested?
- Carrimycin tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Zhao Wang, MD, 63138303, wangzhao@ccmu.edu.cn
About this study
Official title: Clinical Study on the Efficacy and Safety of Carrimycin Tablets in Hemophagocytic Lymphohistiocytosis 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.
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.
- Being tested
- Carrimycin tablets
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carrimycin tabletsDrug
Also called Carrimycin
Carrimycin tablets are administered 400mg a day orally for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Carrimycin tablets | Experimental | Carrimycin tablets Receives: Drug: Carrimycin tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rates of infections
The percentage of participants having clinical cure
Measured: 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)
Measured: 2 weeks after treatment
Secondary outcomes (2)
Overall Survival
OS will be assessed from initiation of treatment to death from any cause
Measured: 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)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem Resistant Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Wang, Beijing Friendship Hospital
- Investigators
- Zhao Wang, MD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988177
- Sponsor's protocol ID
- BFH20230522002
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Carrimycin Tablets in Hemophagocytic Lymphohistiocytosis Patients With Carbapenem-resistant Infections
- ClinicalTrials.gov ID
- NCT05988177
- Acronym / sponsor ID
- BFH20230522002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carrimycin tablets | Experimental | Drug: Carrimycin tabletsCarrimycin tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carrimycin tabletsAlso: CarrimycinCarrimycin tablets are administered 400mg a day orally for 7 days. | Drug | Carrimycin tablets |
Primary outcome
Cure rates of infections
Time frame: 1 week and 2 weeks after initiation of treatment
The percentage of participants having clinical cure
Overall response rate of HLH
Time frame: 2 weeks after treatment
Overall response rate includes complete remission (CR) and partial remission (PR)
2 secondary outcomes
Overall Survival
Time frame: 1 years
Incidence and Severity of Adverse Events
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhao Wang, MD principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carrimycin tablets in people with Carbapenem Resistant Bacterial Infection and Hemophagocytic Lymphohistiocytoses, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Wang, MD (63138303, wangzhao@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rates of infections (time frame: 1 week and 2 weeks after initiation of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.