Antibiotic Therapy for Early Onset Neonatal Sepsis

NCT03932123 | Unknown FDA Drug

• 1 other identifier: 2019_EOS_001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.

Conditions

Early Onset Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  * requiring additional courses of antibiotic therapy within 72 hours after ending initial antibiotic therapy and/or * progression of the illness, necessitating a change of antibiotic and/or * blood culture isolate reported resistant to the antibiotic.

  72 hours after ending initial antibiotic therapy

Secondary Outcomes (8)

• Treatment duration

  Through study completion, an average of 3 days

• Duration of hospitalization

  In the first month of patients' life

• PD target

  Through study completion, an average of 3 days

• White blood cell count

  Through study completion, an average of 3 days

• Procalcitonin

  Through study completion, an average of 3 days

Interventions

Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime DRUG

Efficacy and safety of antibiotics

Eligibility Criteria

• Age: 0 Days - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates suffered from early onset neonatal sepsis

You may qualify if:

• Age: postnatal age ≤ 72h;
• Meets NICE guidelines for using antibiotics to treat EONS;
• Azlocillin used as part of antimicrobial treatment;
• Parental written consent.

You may not qualify if:

• Expected survival time less than the treatment cycle;
• Major congenital malformations;
• Undergoing surgery within the first week of life;
• Receiving other systemic trial drug therapy;

Sponsors & Collaborators

• Shandong University: lead
• Tianjin Central Hospital of Gynecology Obstetrics: collaborator
• Shandong Provincial Hospital: collaborator
• Qianfoshan Hospital: collaborator

Study Sites (1)

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, Tianjin Municipality, 30000, China

RECRUITING

Related Publications (1)

• Wu YE, Wang T, Yang HL, Tang BH, Kong L, Li X, Gao Q, Li X, Yao BF, Shi HY, Huang X, Wang WQ, Jacqz-Aigrain E, Allegaert K, van den Anker J, Tian XY, Zhao W. Population pharmacokinetics and dosing optimization of azlocillin in neonates with early-onset sepsis: a real-world study. J Antimicrob Chemother. 2021 Feb 11;76(3):699-709. doi: 10.1093/jac/dkaa468.

  PMID: 33188385 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Piperacillin; Tazobactam; Azlocillin; Moxalactam; Meropenem

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones; Sulfides; Thienamycins; Carbapenems

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

86053188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 30, 2019
• Study Start: May 5, 2019
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

CN (1)