Immune Dysregulation DisorderNCT06223100
Efficacy and Safety of the Combination Therapy Based on Eravacycline in Immunocompromised Hosts With MDROS Infection
An observational study of Immune Dysregulation Disorder, run by Sichuan Provincial People's Hospital.
Trial summary
The goal of this observational study is to explore the treatment mode and clinical outcome of patients with immunocompromised who received the combined regimen of eraracycline in the treatment of multidrug-resistant bacterial infections, to evaluate the efficacy and safety of the combined regimen of eravacycline in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Dysregulation Disorder
- What is being tested?
- Eravacycline
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: People with low immune function are at high risk of multidrug-resistant bacterial infections, especially those who need long-term immunosuppressive therapy, such as patients with hematological malignancies, solid organ transplant recipients, etc.
Who may be able to join
- ≥ 18 years old.
- Voluntary to participate in this study and signed informed consent. If the subject is unable to read and / or sign the informed consent due to incapacity or other reasons, the guardian of the subject is required to act as the agent of the informed process and sign the informed consent.
- In a state of low immune function:
- In this study, if the patient meets any of the following criteria, the patient 's immune function is considered to be low : 1 patients who have previously received solid organ transplantation ( liver, kidney, lung, heart ) ; 2 hematological malignancies ( leukemia, lymphoma ) ; 3 Patients received long-term immunosuppressive therapy, or used steroids that reached immunosuppressive doses within 21 months before screening ( ≥ 10 mg prednisone or > 15 mg / kg / d hydrocortisone or d > 3 mg / kg / d methylprednisolone, continuous d > 5 days ) [ 4,13 ]. 4 Severe infections occurred recently, leading to extremely low immune function.
- Infections caused by known or highly suspected multidrug-resistant pathogens (MDR), or gram-negative bacteria that are sensitive to eravacycline in adult patients with limited treatment options. The high-risk factors and standards of MDR met the definition of " Chinese expert consensus on prevention and control of nosocomial infection of multidrug-resistant bacteria "; multidrug-resistant bacteria (MDR) refer to bacteria that are resistant to three or more types of commonly used antibiotics that are usually sensitive. Multidrug resistance also includes pan-drug resistance (XDR) and pan-drug resistance (PDR).
- Patients treated with elastin ≥ 3 days.
Who cannot join
- Urinary tract infection.
- Clear culture results showed that microbial pathogens were not sensitive to test drugs (such as Pseudomonas aeruginosa, etc.).
- Patients whose expected survival time cannot exceed the study period.
- The researchers believe that there is any medical history, current condition, treatment, abnormal laboratory examination or other conditions that may affect the test results, interrupt the test process (or the subject cannot complete all the operations and visits required by the test) or accept the test drugs that will increase the risk of the subject. Patients with end-stage diseases have immediate life-threatening disease evidence.
- Patients with a history of allergic reactions to tetracyclines or any adjuvant contained in the study drug formula.
- Vulnerable groups other than critically ill patients, including people with mental illness, cognitive impairment, pregnant women, etc.
About this study
Official title: An Observational Study on the Efficacy and Safety of the Combination Regimen Based on Eravacycline in the Treatment of Multidrug-resistant Bacterial Infections in Immunocompromised Host Populations.
The goal of this observational study is to explore the treatment mode and clinical outcome of patients with immunocompromised who received the combined regimen of eraracycline in the treatment of multidrug-resistant bacterial infections, to evaluate the efficacy and safety of the combined regimen of eravacycline in the treatment of multidrug-resistant bacterial infections in immunocompromised host populations, and to provide data reference for the treatment of immunocompromised populations.
Read the detailed description
The goal of this observational study is to explore the treatment mode and clinical outcome of patients with immunocompromised who received the combined regimen of eraracycline in the treatment of multidrug-resistant bacterial infections, to evaluate the efficacy and safety of the combined regimen of eravacycline in the treatment of multidrug-resistant bacterial infections in immunocompromised host populations, and to provide data reference for the treatment of immunocompromised populations. The main questions it aims to answer are:
- The 30-day all-cause mortality of multi-drug resistant bacterial infections in immunocompromised host populations treated with the combined regimen of eravacycline ;
- Evaluate the clinical cure rate and symptom improvement rate of eravacycline treatment.
According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of eravacycline, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.
- Conditions
- Immune Dysregulation Disorder
- Being tested
- Eravacycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EravacyclineDrug
Also called XERAVA
There is no other intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
Evaluate the 30-day all-cause mortality of multi-drug resistant bacterial infections in immunocompromised host populations treated with the combined regimen of eravacycline.
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Clinical cure rate
Evaluate the clinical cure rate of eravacycline treatment.
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Symptom improvement rate
Evaluate the symptom improvement rate of eravacycline treatment.
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Secondary outcomes (6)
Safety and tolerance of eravacycline
Safety evaluation was mainly based on the incidence of adverse events / adverse reactions in the two groups of patients.
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Microbial clearance rate
In patients who met all clinical evaluation criteria and had positive bacterial culture before treatment, the microbiological efficacy was evaluated at the end of treatment and after treatment (discharge). The results of follow-up (discharge) after treatment were the main evaluation endpoints, and the bacterial clearance rate was calculated. The microbiological efficacy was determined according to the following criteria: clearance, assumed clearance, non-clearance, assumed non-clearance, partial clearance, and others.
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Impact of different treatment timing on eravacycline outcomes as assessed by 30-day all-cause mortality.
The timing of treatment refers to the time when the patients with positive previous culture results start the treatment with eravacycline, one of which assessed the 30-day all-cause mortality of multi-drug resistant bacterial infections in immunocompromised host populations treated with the combined regimen of eravacycline.
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Impact of different treatment timing on eravacycline outcomes as assessed by clinical cure rates.
The timing of treatment refers to the time when the patients with positive previous culture results start the treatment with eravacycline, one of which assessed the clinical cure rate of eravacycline treatment.
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Impact of different treatment timing on eravacycline outcomes as assessed by clinical improvement rates.
The timing of treatment refers to the time when the patients with positive previous culture results start the treatment with eravacycline, one of which assessed the symptom improvement rate of eravacycline treatment.
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
The 30-day infection recurrence rate
The 30-day infection recurrence rate
Measured: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Dysregulation DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223100
- Sponsor's protocol ID
- LPan20230578
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Efficacy and Safety of the Combination Regimen Based on Eravacycline in the Treatment of Multidrug-resistant Bacterial Infections in Immunocompromised Host Populations.
- ClinicalTrials.gov ID
- NCT06223100
- Acronym / sponsor ID
- LPan20230578
- Conditions
- Immune Dysregulation Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 2024 (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.
The goal of this observational study is to explore the treatment mode and clinical outcome of patients with immunocompromised who received the combined regimen of eraracycline in the treatment of multidrug-resistant bacterial infections, to evaluate the efficacy and safety of the combined regimen of eravacycline in the treatment of multidrug-resistant bacterial infections in immunocompromised host populations, and to provide data reference for the treatment of immunocompromised populations.
Detailed description
The goal of this observational study is to explore the treatment mode and clinical outcome of patients with immunocompromised who received the combined regimen of eraracycline in the treatment of multidrug-resistant bacterial infections, to evaluate the efficacy and safety of the combined regimen of eravacycline in the treatment of multidrug-resistant bacterial infections in immunocompromised host populations, and to provide data reference for the treatment of immunocompromised populations. The main questions it aims to answer are:
- The 30-day all-cause mortality of multi-drug resistant bacterial infections in immunocompromised host populations treated with the combined regimen of eravacycline ;
- Evaluate the clinical cure rate and symptom improvement rate of eravacycline treatment.
According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of eravacycline, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with low immune function are at high risk of multidrug-resistant bacterial infections, especially those who need long-term immunosuppressive therapy, such as patients with hematological malignancies, solid organ transplant recipients, etc.
Key inclusion criteria (6 listed)
- ≥ 18 years old.
- Voluntary to participate in this study and signed informed consent. If the subject is unable to read and / or sign the informed consent due to incapacity or other reasons, the guardian of the subject is required to act as the agent of the informed process and sign the informed consent.
- In a state of low immune function:
- In this study, if the patient meets any of the following criteria, the patient 's immune function is considered to be low : 1 patients who have previously received solid organ transplantation ( liver, kidney, lung, heart ) ; 2 hematological malignancies ( leukemia, lymphoma ) ; 3 Patients received long-term immunosuppressive therapy, or used steroids that reached immunosuppressive doses within 21 months before screening ( ≥ 10 mg prednisone or > 15 mg / kg / d hydrocortisone or d > 3 mg / kg / d methylprednisolone, continuous d > 5 days ) [ 4,13 ]. 4 Severe infections occurred recently, leading to extremely low immune function.
- Infections caused by known or highly suspected multidrug-resistant pathogens (MDR), or gram-negative bacteria that are sensitive to eravacycline in adult patients with limited treatment options. The high-risk factors and standards of MDR met the definition of " Chinese expert consensus on prevention and control of nosocomial infection of multidrug-resistant bacteria "; multidrug-resistant bacteria (MDR) refer to bacteria that are resistant to three or more types of commonly used antibiotics that are usually sensitive. Multidrug resistance also includes pan-drug resistance (XDR) and pan-drug resistance (PDR).
Key exclusion criteria (6 listed)
- Urinary tract infection.
- Clear culture results showed that microbial pathogens were not sensitive to test drugs (such as Pseudomonas aeruginosa, etc.).
- Patients whose expected survival time cannot exceed the study period.
- The researchers believe that there is any medical history, current condition, treatment, abnormal laboratory examination or other conditions that may affect the test results, interrupt the test process (or the subject cannot complete all the operations and visits required by the test) or accept the test drugs that will increase the risk of the subject. Patients with end-stage diseases have immediate life-threatening disease evidence.
- Patients with a history of allergic reactions to tetracyclines or any adjuvant contained in the study drug formula.
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 |
|---|---|---|
| EravacyclineAlso: XERAVAThere is no other intervention. | Drug | – |
Primary outcome
30-day all-cause mortality
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Evaluate the 30-day all-cause mortality of multi-drug resistant bacterial infections in immunocompromised host populations treated with the combined regimen of eravacycline.
Clinical cure rate
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Evaluate the clinical cure rate of eravacycline treatment.
Symptom improvement rate
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Evaluate the symptom improvement rate of eravacycline treatment.
6 secondary outcomes
Safety and tolerance of eravacycline
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Microbial clearance rate
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Impact of different treatment timing on eravacycline outcomes as assessed by 30-day all-cause mortality.
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Impact of different treatment timing on eravacycline outcomes as assessed by clinical cure rates.
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Impact of different treatment timing on eravacycline outcomes as assessed by clinical improvement rates.
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
The 30-day infection recurrence rate
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Dysregulation Disorder, run by Sichuan Provincial People's Hospital.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose). The study lists 3 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 25 Jan 2024.