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

NCT06990126 | Enrolling By Invitation FDA Drug

• 1 other identifier: 2025-SR-268
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Efficacy and Safety

Keywords

Eravacycline; Tigecycline; Gram-negative bacteria; adverse drug reactions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbiological efficacy and safety

  14 days

Interventions

bronchoscope DRUG

We will perform bronchoscopy and collect bronchoalveolar lavage fluid(BALF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Bronchoscopes

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 25, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-05

Locations

CN (1)