Understanding how anti-infective drugs work in children with infections
Population Pharmacokinetics of Anti-infective Drugs in Children in Anti-infectious Therapies
Beijing Children's Hospital · NCT03113344
This study is trying to see how children's bodies process anti-infective drugs differently than adults to improve treatment for infections in kids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Beijing Children's Hospital (other) |
| Locations | 1 site (Beijing) |
| Trial ID | NCT03113344 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the pharmacokinetics of anti-infective drugs in children, hypothesizing that their drug metabolism differs from adults. By collecting plasma samples from children receiving these medications, researchers will establish population pharmacokinetic models using advanced modeling techniques. The study will also evaluate the effectiveness and safety of individualized dosing compared to conventional therapies. This research seeks to enhance treatment strategies for infectious diseases in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates include children aged 0-18 years who are undergoing anti-infective therapy for infectious diseases.
Not a fit: Patients who are allergic to anti-infective drugs or those whose conditions do not allow for participation in the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer treatment protocols for children with infectious diseases.
How similar studies have performed: Other studies have shown promise in understanding pharmacokinetics in pediatric populations, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Beijing Children's Hospital of Capital Medical University — Beijing, China (RECRUITING)
Study contacts
- Principal investigator: A-Dong Shen, Master — Beijing Children's Hospital of Capital Medical University
- Study coordinator: A-Dong Shen, Master
- Email: shenad16@hotmail.com
- Phone: +86-010-59616898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Children, Infection