NCT03932123|UnknownFDA Drug
Antibiotic Therapy for Early Onset Neonatal Sepsis
Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis
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Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis
Sponsor study identifier
observational
500
1 country
1
Study Start
May 5, 2019
Actual (reported)Primary Completion
October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 24, 2019
Actual (reported)April 30, 2019
Actual (reported)May 5, 2019
Actual (reported)October 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Efficacy and safety of antibiotics
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordNeonates suffered from early onset neonatal sepsis
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, 30000, China
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.
First Submitted
April 24, 2019
First Posted
April 30, 2019
Study Start
May 5, 2019
Actual (reported)Primary Completion
October 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 20, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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