An observational study in Immune Dysregulation Disorder, sponsored by Sichuan Provincial People's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by Sichuan Provincial People's Hospital · Observational
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 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:
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 100 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Sichuan Provincial People's Hospital is the lead sponsor of 76 studies on the registry; 43 are open to participants now.
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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.
Exclusion Criteria:
There is no other intervention.
Also known as: XERAVA
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.
Time frame: 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.
Time frame: 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.
Time frame: during the treatment (1-14 days); the end of treatment（Day 14）; 28-35 days after first dose
Safety and tolerance of eravacycline
Safety evaluation was mainly based on the incidence of adverse events / adverse reactions in the two groups of patients.
Time frame: 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.
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.
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.
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.
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.
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.
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.
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
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Sichuan Provincial People's Hospital