Children; Infection Clinical Trial
Official title:
Population Pharmacokinetics of Anti-infective Drugs in Children in Anti-infectious Therapies
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.
| Status | Recruiting |
| Enrollment | 800 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | October 1, 2025 |
| 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 infectious diseases. - The anti-infective therapy includes drugs commonly used in children infectious diseases, for example, cephalosporins (such as latamoxef, ceftazidime, ceftriaxone and so on), penicillins (such as penicillin, amoxicillin, ampicillin and so on), macrolides (such as erythromycin, azithromycin and so on), carbapenems (sucn as meropenem, imipenem and so on) and antiviral drugs (such as ganciclovir, acyclovir and so on). - Children infectious diseases include pneumonia, sepsis, purulent meningitis and other diseases with 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 anti-infective drugs. - 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,
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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
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 De — 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 |