Early Onset Neonatal SepsisNCT03932123
Antibiotic Therapy for Early Onset Neonatal Sepsis
An observational study of Early Onset Neonatal Sepsis, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 3 days
- Conditions the study is for
- Early Onset Neonatal Sepsis
- What is being tested?
- Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2019to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates suffered from early onset neonatal sepsis
Who may be able to join
- Age: postnatal age ≤ 72h;
- Meets NICE guidelines for using antibiotics to treat EONS;
- Azlocillin used as part of antimicrobial treatment;
- Parental written consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin Municipality, 30000
Xiuying Tian, bachelor, 022-58287230, txyjk2008@163.com
Xiuying Tian, bachelor
About this study
Official title: Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis
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
- Being tested
- Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaximeDrug
Efficacy and safety of antibiotics
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours after ending initial antibiotic therapy
Secondary outcomes (8)
Treatment duration
Duration of initial antibiotic therapy
Measured: Through study completion, an average of 3 days
Duration of hospitalization
Duration of hospitalization of patients
Measured: In the first month of patients' life
PD target
The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)
Measured: Through study completion, an average of 3 days
White blood cell count
White blood cell count in ×10^9/L
Measured: Through study completion, an average of 3 days
Procalcitonin
Procalcitonin in ng/mL
Measured: Through study completion, an average of 3 days
C-reactive protein
C-reactive protein in mg/L
Measured: Through study completion, an average of 3 days
Death
Death in the first month of life
Measured: In the first month of patients' life
Adverse events
Drug-related adverse events and serious adverse events
Measured: Through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start5 May 2019
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Onset Neonatal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Central Hospital of Gynecology Obstetrics, Shandong Provincial Hospital, Qianfoshan Hospital
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932123
- Sponsor's protocol ID
- 2019_EOS_001
- Status last verified
- Apr 2021
- First submitted
- 24 Apr 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33188385
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT03932123
- Acronym / sponsor ID
- 2019_EOS_001
- Conditions
- Early Onset Neonatal Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Tianjin Central Hospital of Gynecology Obstetrics, Shandong Provincial Hospital, Qianfoshan Hospital
- Study start
- 5 May 2019 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates suffered from early onset neonatal sepsis
Key inclusion criteria (4 listed)
- Age: postnatal age ≤ 72h;
- Meets NICE guidelines for using antibiotics to treat EONS;
- Azlocillin used as part of antimicrobial treatment;
- Parental written consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaximeEfficacy and safety of antibiotics | Drug | – |
Primary outcome
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.
8 secondary outcomes
Treatment duration
Time frame: Through study completion, an average of 3 days
Duration of hospitalization
Time frame: In the first month of patients' life
PD target
Time frame: Through study completion, an average of 3 days
White blood cell count
Time frame: Through study completion, an average of 3 days
Procalcitonin
Time frame: Through study completion, an average of 3 days
C-reactive protein
Time frame: Through study completion, an average of 3 days
Death
Time frame: In the first month of patients' life
Adverse events
Time frame: Through study completion, an average of 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 33188385Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Onset Neonatal Sepsis, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 72 hours after ending initial antibiotic therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.