Late-Onset Neonatal SepsisPhase 4PIP/TAZONCT05981079
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
A Phase 4 study testing Piperacillin/tazobactam in people with Late-Onset Neonatal Sepsis, run by Shandong University at 10 sites in China.
Trial summary
This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen. Read more about this study
- Who is it for?
- Ages 72 hours and older
- Conditions the study is for
- Late-Onset Neonatal Sepsis
- What is being tested?
- Piperacillin/tazobactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 10 sitesChina
- Study dates
- 31 Jul 2023to 31 May 2025
- Phase
- Phase 4
- 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 72 hours and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm neonates: gestational age <34 weeks;
- Postnatal age > 72h;
- Postmenstrual age <36 weeks;
- Newly diagnosed as late-onset sepsis;
- Parental written consent.
Who cannot join
- Patient with bacterial meningitis, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery.
- High suspicion of/confirmed fungal infection.
- Severe congenital malformations and/or severe organ failure.
- Administration of any systemic antibiotic regimen 24 h before screening.
- Administration of other systemic trial drug therapy.
- Other factors that the researcher considers unsuitable for inclusion.
- Post-randomization Exclusion: ①Patients with a positive baseline blood culture and the pathogen resistant to PIP/TAZO. ②Patients with bacterial meningitis, fungal infection, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery after randomization.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Shengli Oilfield Hospital
Dongying
Zhihua Liu
- Not yet recruiting
Jinan Maternity and Child Care Hospital
Jinan
Wenwen Zhang
- Not yet recruiting
Qianfoshan Hospital
Jinan
Dejuan Yang
- Not yet recruiting
Shandong Provincial Hospital
Jinan
Yonghui Yu
- Not yet recruiting
Jining Medical University
Jining
Ru Yang
- Not yet recruiting
Hebei Petro China Center Hospital
Langfang
Huan Li
- Not yet recruiting
Liaocheng People's Hospital
Liaocheng
Lili Zhao
- Not yet recruiting
Taian City Central Hospital
Tai’an
Guo Yao
- Not yet recruiting
W.F. Maternal and Child Health Hospital
Weifang
Ying Zhou
- Recruiting
Yantai Yuhuangding Hospital
Yantai
Shanshan Hou
About this study
Official title: Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in the Treatment of Late-onset Sepsis in Preterm Neonates: a Multicentre, Randomised, Open-label, Non-inferiority Study.
This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen.
- Conditions
- Late-Onset Neonatal Sepsis
- Being tested
- Piperacillin/tazobactam
- Keywords
- late-onset sepsis, piperacillin/tazobactam, model-based dose, empirical dose
- 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/tazobactamDrug
Piperacillin Sodium and Tazobactam Sodium for Injection
| Study group | Role | What they receive |
|---|---|---|
| Model-based dosing regimen | Experimental | Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: GA<28 weeks: 30 mg/kg, Q8H; 28 weeks ≤GA<34 weeks: 50 mg/kg，Q8H. Receives: Drug: Piperacillin/tazobactam |
| Empirical dosing regimen | Active comparator | Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: 90 mg/kg，Q8H. Receives: Drug: Piperacillin/tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful outcome
Successful outcome is defined as:
- Participant is alive.
- No need for replacing the antibiotic or adding new antibiotics.
- At the end of actual piperacillin/tazobactam therapy, ①there is a significant improvement in the participant's overall clinical status, ②there is microbiological resolution or presumed eradication of bacteria and ③no new piperacillin/tazobactam-susceptible pathogens potentially associated with sepsis have been identified.
- Participant does not have a clinically or microbiologically significant relapse or new infection within 10 days after the end of actual piperacillin/tazobactam therapy.
Measured: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Secondary outcomes (6)
Length of NICU stay
Duration of hospital admission (days)
Measured: From the date of randomization until date of discharge, assessed up to 2 months
All cause in-hospital mortality
Death before discharge from NICU
Measured: From the date of randomization until date of discharge, assessed up to 2 months
Proportion of patients switching to or adding another antibiotics.
Proportion of patients switching to or adding another antibiotics by any reason.
Measured: Through study completion, an average of 20 days.
Relapsed or new infection rate
Proportion of patients with clinically or microbiologically significant relapsed or new infection.
Measured: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
PD target attainment
70%fT>MIC
Measured: Through study completion, an average of 20 days.
Adverse events
Drug-related adverse events and serious adverse events
Measured: Through study completion, an average of 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start31 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late-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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qianfoshan Hospital, Jinan Maternity and Child Care Hospital, Yantai Yuhuangding Hospital, Hebei Petro China Center Hospital, Shengli Oilfield Hospital, Liaocheng People's Hospital, Jining Medical University, W.F. Maternal and Child Health Hospital, Taian City Central Hospital
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Ph.D, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981079
- Sponsor's protocol ID
- SDU-2023-NeoPIP-002
- Acronym
- PIP/TAZO
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in the Treatment of Late-onset Sepsis in Preterm Neonates: a Multicentre, Randomised, Open-label, Non-inferiority Study.
- ClinicalTrials.gov ID
- NCT05981079
- Acronym / sponsor ID
- PIP/TAZO / SDU-2023-NeoPIP-002
- Conditions
- Late-Onset Neonatal Sepsis
- Keywords
- late-onset sepsis, piperacillin/tazobactam, model-based dose, empirical dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qianfoshan Hospital, Jinan Maternity and Child Care Hospital, Yantai Yuhuangding Hospital, Hebei Petro China Center Hospital, Shengli Oilfield Hospital, Liaocheng People's Hospital, Jining Medical University, W.F. Maternal and Child Health Hospital, Taian City Central Hospital
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 8 Aug 2023 (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.
This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model-based dosing regimen | Experimental | Drug: Piperacillin/tazobactamDrug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: GA<28 weeks: 30 mg/kg, Q8H; 28 weeks ≤GA<34 weeks: 50 mg/kg，Q8H. |
| Empirical dosing regimen | Active comparator | Drug: Piperacillin/tazobactamDrug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: 90 mg/kg，Q8H. |
Who may qualify
- Ages
- 72 hours and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Preterm neonates: gestational age <34 weeks;
- Postnatal age > 72h;
- Postmenstrual age <36 weeks;
- Newly diagnosed as late-onset sepsis;
- Parental written consent.
Key exclusion criteria (7 listed)
- Patient with bacterial meningitis, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery.
- High suspicion of/confirmed fungal infection.
- Severe congenital malformations and/or severe organ failure.
- Administration of any systemic antibiotic regimen 24 h before screening.
- Administration of other systemic trial drug therapy.
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/tazobactamPiperacillin Sodium and Tazobactam Sodium for Injection | Drug | Empirical dosing regimen, Model-based dosing regimen |
Primary outcome
Successful outcome
Time frame: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Successful outcome is defined as: 1. Participant is alive. 2. No need for replacing the antibiotic or adding new antibiotics. 3. At the end of actual piperacillin/tazobactam therapy, ①there is a significant improvement in the participant's overall clinical status, ②there is microbiological resolution or presumed eradication of bacteria and ③no new piperacillin/tazobactam-susceptible pathogens potentially associated with sepsis have been identified. 4. Participant does not have a clinically or microbiologically significant relapse or new infection within 10 days after the end of actual piperacillin/tazobactam therapy.
6 secondary outcomes
Length of NICU stay
Time frame: From the date of randomization until date of discharge, assessed up to 2 months
All cause in-hospital mortality
Time frame: From the date of randomization until date of discharge, assessed up to 2 months
Proportion of patients switching to or adding another antibiotics.
Time frame: Through study completion, an average of 20 days.
Relapsed or new infection rate
Time frame: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
PD target attainment
Time frame: Through study completion, an average of 20 days.
Adverse events
Time frame: Through study completion, an average of 20 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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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.
Wei Zhao, Ph.D principal investigator
Shandong University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Piperacillin/tazobactam in people with Late-Onset Neonatal Sepsis, run by Shandong University at 10 sites 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 5 inclusion and 7 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+8653188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful outcome (time frame: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.