Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Yu-Jie Qi | Other Identifier | Beijing Children's Hospital | |
| Wei Zhao | Other Identifier | Children's Hospital of Hebei Provinceï¼›Shandong Provincial Qianfoshan Hospital | |
| Hui Qi | Other Identifier | Beijing Children's Hospital | |
| Fei Jin | Other Identifier | Beijing Children's Hospital | |
| Evelyne Jacqz-Aigrain | Other Identifier | Robert Debre Hospital,Paris France | |
| Stephanie Leroux | Other Identifier | Centre Hospitalier Universitaire de Rennes, France |
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
Not provided
This study is based on the hypothesis that the pharmacokinetics of anti-infective drugs in children are different from adults. We aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious diseases. In this study, we will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, we also want to correlate use of anti-infective drugs with treatment effectiveness and incidence of adverse effects in children. This novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in children. It will also set the foundation for further studies to improve anti-infective drug therapies for children.
1.Establish population pharmacokinetic (PPK) models of each anti-infective drug in 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cephalosporins,penicillins,macrolides,carbapenems and antiviral 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
Children with anti-infectious therapies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A-Dong Shen, Master | Contact | +86-010-59616898 | shenad16@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| A-Dong Shen, Master | Beijing Children's Hospital of Capital Medical University | Principal Investigator |
| Yu-Jie Qi, 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 |
|---|---|---|---|
| 23254142 | Result | Zhao W, Lopez E, Biran V, Durrmeyer X, Fakhoury M, Jacqz-Aigrain E. Vancomycin continuous infusion in neonates: dosing optimisation and therapeutic drug monitoring. Arch Dis Child. 2013 Jun;98(6):449-53. doi: 10.1136/archdischild-2012-302765. Epub 2012 Dec 19. | |
| 25628457 | Result | Leroux S, Zhao W, Betremieux P, Pladys P, Saliba E, Jacqz-Aigrain E; French Society of Neonatology. Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national survey. Arch Dis Child. 2015 Apr;100(4):394-8. doi: 10.1136/archdischild-2014-306873. Epub 2015 Jan 27. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D000998 | Antiviral Agents |
| D009070 | Moxalactam |
| D002443 | Ceftriaxone |
| D002442 | Ceftazidime |
| D000667 | Ampicillin |
| D010406 | Penicillins |
| D000658 | Amoxicillin |
| D004917 | Erythromycin |
| D017963 | Azithromycin |
| D000077731 | Meropenem |
| D015378 | Imipenem |
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 |
Not provided
Not provided
Not provided
Not provided
Not provided
whole blood and plasma
|
| 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 |
| Wei Zhao, Doctor | Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital | Study Director |
| 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. |
| 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. |
| 33020163 | Derived | Kan M, Shi HY, Han B, Wu YE, Li Q, Guo ZX, Li X, Hao GX, Zheng Y, Su LQ, Huang X, Sui ZG, Zhao W. Prediction of Unbound Ceftriaxone Concentration in Children: Simple Bioanalysis Method and Basic Mathematical Equation. Antimicrob Agents Chemother. 2020 Dec 16;65(1):e00779-20. doi: 10.1128/AAC.00779-20. Print 2020 Dec 16. |
| 32129861 | Derived | Shi HY, Wang K, Wang RH, Wu YE, Tang BH, Li X, Du B, Kan M, Zheng Y, Xu BP, Shen AD, Su LQ, Jacqz-Aigrain E, Huang X, Zhao W. Developmental population pharmacokinetics-pharmacodynamics and dosing optimization of cefoperazone in children. J Antimicrob Chemother. 2020 Jul 1;75(7):1917-1924. doi: 10.1093/jac/dkaa071. |
| 30962334 | Derived | Dong L, Zhai XY, Yang YL, Wang L, Zhou Y, Shi HY, Tang BH, Wu YE, Yang F, Wen L, Kong HX, Zhi LJ, Jacqz-Aigrain E, Zhao W. Population Pharmacokinetics and Dosing Optimization of Imipenem in Children with Hematological Malignancies. Antimicrob Agents Chemother. 2019 May 24;63(6):e00006-19. doi: 10.1128/AAC.00006-19. Print 2019 Jun. |
| 29507070 | Derived | Dong Q, Leroux S, Shi HY, Xu HY, Kou C, Khan MW, Jacqz-Aigrain E, Zhao W. Pilot Study of Model-Based Dosage Individualization of Ganciclovir in Neonates and Young Infants with Congenital Cytomegalovirus Infection. Antimicrob Agents Chemother. 2018 Apr 26;62(5):e00075-18. doi: 10.1128/AAC.00075-18. Print 2018 May. |
| Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013440 | Sulfides |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002509 | Cephaloridine |
| D010400 | Penicillin G |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |