Clinical trial NCT06990126: The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
Official title: A Real World Study on the Clinical Efficacy and Adverse Reactions of Neotetracycline Drugs in the Treatment of Gram-negative Bacterial Infections
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Infections With Drug-resistant Gram-negative Bacteria
Keywords: resistant Lung infection gram-negative
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with infections clinically caused by drug-resistant gram-negative bacteria (other than CRPA) and treated with eravacycline and tigecycline

Brief summary: A multicenter, retrospective, real-world stduy . Subjects with composite criteria were teated with eravacycline ,and 100 cases ,Tigecycline and 300 cases were to be enrolled.

Detailed description: The study is a multicenter, retrospective, real-world study, through retrospective collection of cases of gram-negative bacterial infections in the First Affiliated Hospital of Nanjing Medical University, Nanjing Drum Tower Hospital, Nanjing First Hospital, Shaw Hospital Affiliated to Nanjing Medical University, Affiliated Hospital of Xuzhou Medical University, and Xuzhou Central Hospital, and 100 cases of eravacycline,300 cases of tigecycline are planned to be enrolled.

Inclusion Criteria:

Meet the clinical criteria for the diagnosis and treatment of drug-resistant gram-negative bacterial infection; Acute Physiology and Chronic Health Score (APACHEII) \< 25 points; The treatment time of eravacycline or tigecycline ≥ 72 hours; Adults aged 18 and above.

Exclusion Criteria:

Allergy to tetracycline antimicrobial drugs; pregnant and lactating females; Patients with advanced tumors/malignant tumors, chemoradiotherapy, severe immunodeficiency or psychiatric diseases; Patients with severe hepatic and renal insufficiency (Child-Pugh class C); Other patients who are considered by the investigator to be unsuitable for enrollment.

Rejection Criteria: None

Data acquisition:

General condition: age, gender, acute physiology and chronic health status score (APACHEII), endotracheal intubation/tracheostomy, site of infection, course of treatment, presence of other pathogens, concomitant use of other antibiotics, and ICU admission; Specimen source: blood/respiratory/other; Drug-resistant pathogens: Acinetobacter baumannii/Klebsiella pneumoniae/Escherichia coli; Evaluation of clinical efficacy and bacterial efficacy during treatment with eravacycline and tigecycline; Common adverse reactions in eravacycline or tigecycline therapy; Treatment options Recommended dose of eravacycline : calculated according to the patient's weight, intravenous infusion at 1mg/kg, q12h, the infusion duration is not less than 60 minutes, and the recommended course of treatment is 4-14 days. The investigator can adjust the specific medication regimen according to the severity and location of the patient's infection and the patient's clinical response.

Recommended dose of tigecycline is 100 mg as a loading dose and 50 mg every 12 hours as a maintenance dose, and for multidrug-resistant infections, a high-dose tigecycline 200 mg as an initial dose and a maintenance dose up to 100 mg every 12 hours.

Eligibility criteria: Inclusion Criteria:

Meet the clinical criteria for the diagnosis and treatment of drug-resistant gram-negative bacterial infection; Acute Physiology and Chronic Health Score (APACHEII) \< 25 points; The treatment time of eravacycline or tigecycline ≥ 72 hours; Adults aged 18 and above.

Exclusion Criteria:

Allergy to tetracycline antimicrobial drugs; pregnant and lactating females; Patients with advanced tumors/malignant tumors, chemoradiotherapy, severe immunodeficiency or psychiatric diseases; Patients with severe hepatic and renal insufficiency (Child-Pugh class C); Other patients who are considered by the investigator to be unsuitable for enrollment.

Primary outcomes:
measure: Clinical efficacy
timeFrame: 14 days
Secondary outcomes:
measure: Microbiological efficacy and safety
timeFrame: 14 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: