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NCT03643497
Population Pharmacokinetics of Meropenem and Linezolid in Children With Severe Infectious Diseases
trial testing anti-infective drugs in Children;Infection in 800 participants. Status unknown.
30 September 2021
Quick facts
| Lead sponsor | Beijing Children's Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 800 |
| Start date | 1 July 2018 |
| Primary completion | 30 September 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- anti-infective drugs — full drug profile →
Conditions studied
- Children;Infection — all drugs for Children;Infection →
Sponsor
Beijing Children's Hospital
Who can join
Adults 1 Day to 18, any sex, with Children;Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Reappraisal of the Optimal Dose of Meropenem in Critically Ill Infants and Children: a Developmental Pharmacokinetic-Pharmacodynamic Analysis.
Wang ZM, Chen XY, Bi J, Wang MY, et al · · 2020 · cited 21× · PMID 32513801 · DOI 10.1128/aac.00760-20 -
Improving the efficacy for meropenem therapy requires a high probability of target attainment in critically ill infants and children.
Wang Z, Bi J, You D, Tang Y, et al · · 2022 · cited 2× · PMID 36278190 · DOI 10.3389/fphar.2022.961863
Verify or expand the search:
- PubMed search for NCT03643497
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03643497 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Children's Hospital
- Last refreshed: 23 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03643497.
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