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

A Real World Study on the Clinical Efficacy and Adverse Reactions of Neotetracycline Drugs in the Treatment of Gram-negative Bacterial Infections

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Clinical Efficacy and Safety
• Intervention / Treatment: Drug: bronchoscope

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:

Bacteriological results show drug-resistant Gram-negative bacteria Use of new tetracycline drugs for ≥72 hours Age ≥18 years

Exclusion Criteria:

Advanced tumors Severe immunodeficiency or mental illness Severe liver and kidney dysfunction Pregnant or breastfeeding women 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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

Bacteriological results show drug-resistant Gram-negative bacteria Use of new tetracycline drugs for ≥72 hours Age ≥18 years

Exclusion Criteria:

Advanced tumors Severe immunodeficiency or mental illness Severe liver and kidney dysfunction Pregnant or breastfeeding women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical efficacy	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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological efficacy and safety	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.	14 days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: May 19, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Tigecycline; Gram-negative bacteria; adverse drug reactions; Eravacycline
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Surgical Equipment; Equipment and Supplies; Diagnostic Equipment; Endoscopes; Bronchoscopes
• Other Study ID Numbers: 2025-SR-268

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No