UnknownNot Applicable

Efficacy and Safety of the Combination Therapy Based on Eravacycline in Immunocompromised Hosts With MDROS Infection

100 participantsStarted 2024-02-01

Plain-language 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 the treatment of multidrug-resistant bacterial infections in immunocompromised host populations, and to provide data reference for the treatment of immunocompromised populations.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥ 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 antibi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

30-day all-cause mortality

Timeframe: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose

Clinical cure rate

Timeframe: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose

Symptom improvement rate

Timeframe: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose

Trial details

NCT IDNCT06223100

SponsorSichuan Provincial People's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Immune Dysregulation Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

30-day all-cause mortality

Timeframe: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose

Clinical cure rate

Timeframe: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose

Symptom improvement rate

Timeframe: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose