Children;Infection Clinical Trial
Official title:
Population Pharmacokinetics of Meropenem and Linezolid in Children With Severe Infectious Diseases
| NCT number | NCT03643497 |
| Other study ID # | BCH_PPK004 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 1, 2018 |
| Est. completion date | December 31, 2021 |
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.
| Status | Recruiting |
| Enrollment | 800 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | September 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
Inclusion Criteria: - Children (0-18 years old) with anti-infective therapy against severe infectious diseases. - The anti-infective therapy includes meropenem and linezolid commonly used in children with infectious diseases, - Children severe infectious diseases include severe pneumonia, sepsis, purulent meningitis and other diseases with severe infection. - Informed consent signed by the parents and/or guardians Exclusion Criteria: - Anti-infective drugs aren't involved in the therapies of children. - It is unable to provide complete medical records or the current condition cannot accept the study process. - Patients are allergic to meropenem or linezolid. - Parents and/or guardians do not agree to participate in this study. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Children's Hospital of Capital Medical University | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Children's Hospital | Centre Hospitalier Universitaire de Rennes, Robert Debré Hospital, Shandong University |
China,
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. Review. — View Citation
Ramos-Martín V, Johnson A, Livermore J, McEntee L, Goodwin J, Whalley S, Docobo-Pérez 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 vancomyci — View Citation
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 o — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | absorption rate constant (ka) | Ka is the rate constant of drug absorption | up to 4 weeks | |
| Secondary | 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 | |
| Secondary | half-life (t1/2) | Half-life is the time required for a quantity to reduce to half its initial value | up to 4 weeks |