Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shandong University | OTHER |
| Hopital Universitaire Robert-Debre | OTHER |
| Rennes University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This study is based on the hypothesis that the pharmacokinetics of meropenem and linezolid in severe infectious children are different from mild infectious children and adults. The investigators aim to study the population pharmacokinetics of children receiving the meropenem and linezolid for treatment of severe infectious diseases. In this study, the investigators will detect drug concentration in plasma and cerebrospinal fluid by using residual blood samples of blood and cerebrospinal fluid gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, the investigators also want to correlate use of meropenem and linezolid with treatment effectiveness and incidence of adverse effects in children. This novel knowledge will allow better and more rational approaches to the treatment of severe infectious diseases in children. It will also set the foundation for further studies to improve anti- infective drug therapies for severe infectious children.
1.Establish population pharmacokinetic (PPK) models of meropenem and linezolid in severe infectious children by nonlinear mixed effect modeling (NONMEM).
2. Evaluation of the clinical feasibility and safety of individualized dosing.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with the usage of anti-infective drugs | Children received meropenem or linezolid monotherapy in the treatment of seven infectious diseases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-infective drugs | Drug | According to the models of population pharmacokinetics, the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentration (Cmax) | Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| time to achieve maximum concentration (Tmax) | Tmax is the term used in pharmacokinetics to describe the time at which the Cmax is observed | up to 4 weeks |
| absorption rate constant (ka) | Ka is the rate constant of drug absorption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Severe infectious children with anti-infectious therapies
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shen A-Dong, Master | Contact | 010-59616898 | shenad16@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shen A-Dong, Master | Beijing Children's Hospital of Capital Medical University | Principal Investigator |
| Qi Yu-Jie, Master | Beijing Children's Hospital of Capital Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital of Capital Medical University | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26289222 | Result | Jacqz-Aigrain E, Leroux S, Zhao W, van den Anker JN, Sharland M. How to use vancomycin optimally in neonates: remaining questions. Expert Rev Clin Pharmacol. 2015;8(5):635-48. doi: 10.1586/17512433.2015.1060124. Epub 2015 Aug 4. | |
| 26755499 | Result | Ramos-Martin V, Johnson A, Livermore J, McEntee L, Goodwin J, Whalley S, Docobo-Perez F, Felton TW, Zhao W, Jacqz-Aigrain E, Sharland M, Turner MA, Hope WW. Pharmacodynamics of vancomycin for CoNS infection: experimental basis for optimal use of vancomycin in neonates. J Antimicrob Chemother. 2016 Apr;71(4):992-1002. doi: 10.1093/jac/dkv451. Epub 2016 Jan 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D000077731 | Meropenem |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013845 | Thienamycins |
Not provided
Not provided
Not provided
Not provided
Not provided
whole blood and plasma and cerebrospinal fluid
|
| up to 4 weeks |
| elimination rate constant (kel) | The elimination rate constant is a value used in pharmacokinetics to describe the rate at which a drug is removed from the system | up to 4 weeks |
| half-life (t1/2) | Half-life is the time required for a quantity to reduce to half its initial value | up to 4 weeks |
| Zhao Wei, Doctor | Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital | Study Director |
| 25155587 | Result | Zhao W, Hill H, Le Guellec C, Neal T, Mahoney S, Paulus S, Castellan C, Kassai B, van den Anker JN, Kearns GL, Turner MA, Jacqz-Aigrain E; TINN Consortium. Population pharmacokinetics of ciprofloxacin in neonates and young infants less than three months of age. Antimicrob Agents Chemother. 2014 Nov;58(11):6572-80. doi: 10.1128/AAC.03568-14. Epub 2014 Aug 25. |
| 36278190 | Derived | Wang Z, Bi J, You D, Tang Y, Liu G, Yu J, Jin Z, Jiang T, Tian X, Qi H, Dong L, Dong L, Zhang Q, Zhao W, Shen A. Improving the efficacy for meropenem therapy requires a high probability of target attainment in critically ill infants and children. Front Pharmacol. 2022 Oct 5;13:961863. doi: 10.3389/fphar.2022.961863. eCollection 2022. |
| 32513801 | Derived | Wang ZM, Chen XY, Bi J, Wang MY, Xu BP, Tang BH, Li C, Zhao W, Shen AD. Reappraisal of the Optimal Dose of Meropenem in Critically Ill Infants and Children: a Developmental Pharmacokinetic-Pharmacodynamic Analysis. Antimicrob Agents Chemother. 2020 Jul 22;64(8):e00760-20. doi: 10.1128/AAC.00760-20. Print 2020 Jul 22. |
| D015780 |
| Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |