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

- Drug: Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin
Efficacy and safety of antibiotics
- 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.
- Treatment duration [ Time Frame: Through study completion, an average of 3 days ]Duration of initial antibiotic therapy
- Duration of hospitalization [ Time Frame: In the first month of patients' life ]Duration of hospitalization of patients
- 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)
- White blood cell count [ Time Frame: Through study completion, an average of 3 days ]White blood cell count in ×10^9/L
- Procalcitonin [ Time Frame: Through study completion, an average of 3 days ]Procalcitonin in ng/mL
- C-reactive protein [ Time Frame: Through study completion, an average of 3 days ]C-reactive protein in mg/L
- Death [ Time Frame: In the first month of patients' life ]Death in the first month of life
- Adverse events [ Time Frame: Through study completion, an average of 3 days ]Drug-related adverse events and serious adverse events

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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 |
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.

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
Contact: Wei Zhao, Ph.D | 86053188383308 | zhao4wei2@hotmail.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |