Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis
ConditionTuberculosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorBeijing Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Children with anti-tuberculosis therapies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
anti-tuberculosis drug
DrugThe intervention drugs are prescribed by treating caregiver
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
maximum concentration (Cmax)
Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum
Time frame
up to 4 weeksSecondary outcomes
1
time to achieve maximum concentration (Tmax)
Tmax is the term used in pharmacokinetics to describe the time at which the Cmax
Time frame
up to 4 weeks2
absorption rate constant (ka)
Ka is the rate constant of drug absorption.
Time frame
up to 4 weeks3
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.
Time frame
up to 4 weeks4
half-life (t1/2)
Half-life is the time required for a quantity to reduce to half its initial value.
Time frame
up to 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Children's Hospital
Lead sponsor
Shandong University
Collaborator
Hopital Universitaire Robert-Debre
Collaborator
Rennes University Hospital
Collaborator
Source ClinicalTrials.gov