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| Name | Class |
|---|---|
| Tianjin Central Hospital of Gynecology Obstetrics | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Qianfoshan Hospital | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin,cefotaxime | Drug | Efficacy and safety of antibiotics |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure |
| 72 hours after ending initial antibiotic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment duration | Duration of initial antibiotic therapy | Through study completion, an average of 3 days |
| Duration of hospitalization | Duration of hospitalization of patients |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates suffered from early onset neonatal sepsis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao, Ph.D | Contact | 86053188383308 | zhao4wei2@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Central Hospital of Gynecology Obstetrics | Recruiting | Tianjin | Tianjin Municipality | 30000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33188385 | Derived | 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. |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D010878 | Piperacillin |
| D000078142 | Tazobactam |
| D001390 | Azlocillin |
| D009070 | Moxalactam |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| In the first month of patients' life |
| PD target | The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC) | Through study completion, an average of 3 days |
| White blood cell count | White blood cell count in ×10^9/L | Through study completion, an average of 3 days |
| Procalcitonin | Procalcitonin in ng/mL | Through study completion, an average of 3 days |
| C-reactive protein | C-reactive protein in mg/L | Through study completion, an average of 3 days |
| Death | Death in the first month of life | In the first month of patients' life |
| Adverse events | Drug-related adverse events and serious adverse events | Through study completion, an average of 3 days |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010397 | Penicillanic Acid |
| D013450 | Sulfones |
| D013440 | Sulfides |
| D013845 | Thienamycins |
| D015780 | Carbapenems |