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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03625739
Other study ID # BCH_PPK003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date December 31, 2026

Study information

Verified date August 2018
Source Beijing Children's Hospital
Contact A-Dong Shen, Master
Phone +86-010-59616898
Email shenad16@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study is based on the hypothesis that the pharmacokinetics of anti-tuberculosis drugs in TB children are different from adults. The investigators aim to study the population pharmacokinetics of children receiving the anti-tuberculsis drugs for treatment of TB. In this study, the investigators 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, the investigators also want to correlate use of anti-tuberculsis 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 TB in children. It will also set the foundation for further studies to improve anti-tuberculosis drug therapies for children.


Description:

1.Establish population pharmacokinetic (PPK) models of each anti-tuberculsis drug in children by nonlinear mixed effect modeling (NONMEM).

1. At different timepoint after anti-tuberculsis drug administration, plasma samples of 100 children will be collected from neonatal intensive care unit (NICU) and pneumology department for each drug. The clinical information includes demography, medication, concentration data, blood biochemical parameters and so on .

2. Plasma samples will be tested by high performance liquid chromatography (HPLC).

3. PPK models of anti-tuberculsis drug will be established by NONMEM program.

4. The reliability and stability of the PPK model will be evaluated by 1000 times of Bootstrap procedure and normalized predictive distribution error (NPDE).

2.Evaluation of the clinical feasibility and safety of individualized dosing.

1. According the results of PPK models, the investigators will use dosages recommended in models to cure TB children in prospective studies. For anti-tuberculsis drug, 50 children will be collected.

2. The investigators will compare the therapeutic effects and safety between children with conventional therapies and children with individualized therapies, including proportions of children with effective drug concentration, improvement speed of of children, liver and kidney functions of of children, adverse reactions of drugs and so on.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 31, 2026
Est. primary completion date October 1, 2026
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Children (0-18 years old) with anti-tuberculosis therapy against TB.

- The anti-tuberculsis therapy includes drugs commonly used in children infectious diseases

- Informed consent signed by the parents and/or guardians.

Exclusion Criteria:

- Anti-tuberculosis 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-tuberculsis drugs.

- Parents and/or guardians do not agree to participate in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
anti-tuberculosis drug
The intervention drugs are prescribed by treating caregiver

Locations

Country Name City State
China Beijing Children's Hospital of Capital Medical University Beijing

Sponsors (4)

Lead Sponsor Collaborator
Beijing Children's Hospital Centre Hospitalier Universitaire de Rennes, Robert Debré Hospital, Shandong University

Country where clinical trial is conducted

China, 

References & Publications (3)

Ho PL, Lo PY, Chow KH, Lau EH, Lai EL, Cheng VC, Kao RY. Vancomycin MIC creep in MRSA isolates from 1997 to 2008 in a healthcare region in Hong Kong. J Infect. 2010 Feb;60(2):140-5. doi: 10.1016/j.jinf.2009.11.011. Epub 2009 Dec 2. — View Citation

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

Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 Sep 18;349(12):1157-67. Review. — View Citation

Outcome

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 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 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
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