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Antibiotic Therapy for Early Onset Neonatal Sepsis

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ClinicalTrials.gov Identifier: NCT03932123
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
Tianjin Central Hospital of Gynecology Obstetrics
Shandong Provincial Hospital
Qianfoshan Hospital
Information provided by (Responsible Party):
Wei Zhao, Shandong University

Study Description
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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.

Condition or disease Intervention/treatment
Early Onset Neonatal Sepsis Drug: Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Groups and Cohorts
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Intervention Details:
  • Drug: Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin
    Efficacy and safety of antibiotics

Outcome Measures
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Primary Outcome Measures :
  1. Treatment failure [ Time Frame: 72 hours after ending initial antibiotic therapy ]
    • 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.


Secondary Outcome Measures :
  1. Treatment duration [ Time Frame: Through study completion, an average of 3 days ]
    Duration of initial antibiotic therapy

  2. Duration of hospitalization [ Time Frame: In the first month of patients' life ]
    Duration of hospitalization of patients

  3. PD target [ Time Frame: Through study completion, an average of 3 days ]
    The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)

  4. White blood cell count [ Time Frame: Through study completion, an average of 3 days ]
    White blood cell count in ×10^9/L

  5. Procalcitonin [ Time Frame: Through study completion, an average of 3 days ]
    Procalcitonin in ng/mL

  6. C-reactive protein [ Time Frame: Through study completion, an average of 3 days ]
    C-reactive protein in mg/L

  7. Death [ Time Frame: In the first month of patients' life ]
    Death in the first month of life

  8. Adverse events [ Time Frame: Through study completion, an average of 3 days ]
    Drug-related adverse events and serious adverse events


Eligibility Criteria
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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates suffered from early onset neonatal sepsis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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;
  • Other factors that the researcher considers unsuitable for inclusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932123


Contacts
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Contact: Wei Zhao, Ph.D 86053188383308 zhao4wei2@hotmail.com

Locations
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China, Tianjin
Tianjin Central Hospital of Gynecology Obstetrics Recruiting
Tianjin, Tianjin, China, 30000
Contact: Xiuying Tian, bachelor    022-58287230    txyjk2008@163.com   
Sub-Investigator: Xiuying Tian, bachelor         
Sponsors and Collaborators
Shandong University
Tianjin Central Hospital of Gynecology Obstetrics
Shandong Provincial Hospital
Qianfoshan Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wei Zhao, Head of department of clinical pharmacy and pharmacology, Shandong University
ClinicalTrials.gov Identifier: NCT03932123    
Other Study ID Numbers: 2019_EOS_001
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Sepsis
Toxemia
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
 Infant, Newborn, Diseases
Vancomycin
Meropenem
Tazobactam
Piperacillin
Azlocillin
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action