Population Pharmacokinetics of Meropenem and Linezolid in Children With Severe Infectious Diseases

NCT03643497 | Unknown

• 1 other identifier: BCH_PPK004
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children；Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• time to achieve maximum concentration (Tmax)

  up to 4 weeks

• absorption rate constant (ka)

  up to 4 weeks

• elimination rate constant (kel)

  up to 4 weeks

• half-life (t1/2)

  up to 4 weeks

Study Arms (1)

Children with the usage of anti-infective drugs

Children received meropenem or linezolid monotherapy in the treatment of seven infectious diseases

Drug: anti-infective drugs

Interventions

anti-infective 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

Also known as: meropenem, linezolid

Children with the usage of anti-infective drugs

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Severe infectious children with anti-infectious therapies

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Children's Hospital: lead
• Shandong University: collaborator
• Hopital Universitaire Robert-Debre: collaborator
• Rennes University Hospital: collaborator

Study Sites (1)

Beijing Children's Hospital of Capital Medical University

Beijing, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 26289222 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.

  PMID: 26755499 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.

  PMID: 25155587 RESULT

• Wang Z, Bi J, You D, Tang Y, Liu G, Yu J, Jin Z, Jiang T, Tian X, Qi H, Dong L, Dong L, Zhang Q, Zhao W, Shen A. Improving the efficacy for meropenem therapy requires a high probability of target attainment in critically ill infants and children. Front Pharmacol. 2022 Oct 5;13:961863. doi: 10.3389/fphar.2022.961863. eCollection 2022.

  PMID: 36278190 DERIVED

• Wang ZM, Chen XY, Bi J, Wang MY, Xu BP, Tang BH, Li C, Zhao W, Shen AD. Reappraisal of the Optimal Dose of Meropenem in Critically Ill Infants and Children: a Developmental Pharmacokinetic-Pharmacodynamic Analysis. Antimicrob Agents Chemother. 2020 Jul 22;64(8):e00760-20. doi: 10.1128/AAC.00760-20. Print 2020 Jul 22.

  PMID: 32513801 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and plasma and cerebrospinal fluid

MeSH Terms

Interventions

Anti-Infective Agents; Meropenem; Linezolid

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetamides; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Shen A-Dong, Master

  Beijing Children's Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

• Qi Yu-Jie, Master

  Beijing Children's Hospital of Capital Medical University

  STUDY DIRECTOR

• Zhao Wei, Doctor

  Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Shen A-Dong, Master

CONTACT

010-59616898; shenad16@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of China National Clinical Research Center for Respiratory Diseases

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: July 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)