The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bronchoscope.
- Who it may be relevant to
- Registry conditions: Clinical Efficacy and Safety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Real World Study on the Clinical Efficacy and Adverse Reactions of Neotetracycline Drugs in the Treatment of Gram-negative Bacterial Infections
Overview
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:
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.
Interventions
- Drug bronchoscope
We will perform bronchoscopy and collect bronchoalveolar lavage fluid(BALF)
Primary outcome measures
- Clinical efficacy [Time frame: 14 days]
Secondary outcome measures (1)
- Microbiological efficacy and safety [Time frame: 14 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06990126 · 2025-SR-268