The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections

• Conditions: Infections With Drug-resistant Gram-negative Bacteria

• Registration Number: NCT06990126
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2025-04-17
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical efficacy	14 days	The main outcome is the clinical results of assessed by clinical physicians, where clinical outcomes are recorded as successful or unsuccessful, defined by the relief of clinical symptoms, which is defined as imaging improvement determined by the clinician, normalization or significant reduction of white blood cell counts and related inflammatory indicators including CRP, PCT, IL-6, etc.

Secondary Outcome Measures

Name	Time	Method
Microbiological efficacy and safety	14 days	The secondary outcome is the microbiological efficacy, namely the control of bacterial infections during hospitalization (including the clearance and partial clearance of bacteria) and safety, which is assessed by evaluating the incidence of adverse events and changes in clinical laboratory test results (including liver and kidney functions, coagulation function, etc.) for all study subjects.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China