Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

NCT03625739 | Recruiting

• 1 other identifier: BCH_PPK003
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• maximum concentration (Cmax)

  Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum

  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

Interventions

anti-tuberculosis drug DRUG

The intervention drugs are prescribed by treating caregiver

Also known as: Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, Levofloxacin, Moxifloxacin, Gatifloxacin, Amikacin, Capreomycin, Kanamycin (Streptomycin), Ethionamide, Cycloserine, terizidone, Clofazimine, Bedaquiline, Delamanid, p-aminosalicylic acid, Imipenem-cilastatind, Amoxicillin-clavulanate, Thioacetazone

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with anti-tuberculosis therapies.

You may qualify if:

• 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.

You may not qualify if:

• 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.

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 (3)

• 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 BACKGROUND

• 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.

  PMID: 19961873 BACKGROUND

• 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. doi: 10.1056/NEJMra035092. No abstract available.

  PMID: 13679531 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and plasma

MeSH Terms

Conditions

Tuberculosis

Interventions

Antitubercular Agents; Isoniazid; Rifampin; Pyrazinamide; Ethambutol; Levofloxacin; Moxifloxacin; Gatifloxacin; Amikacin; Capreomycin; Kanamycin; Streptomycin; Ethionamide; Cycloserine; terizidone; Clofazimine; bedaquiline; OPC-67683; Aminosalicylic Acid; Amoxicillin-Potassium Clavulanate Combination; Thioacetazone

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Pyrazines; Ethylenediamines; Diamines; Polyamines; Amines; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Aminoglycosides; Glycosides; Carbohydrates; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Isoxazoles; Azoles; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Phenazines; Heterocyclic Compounds, 3-Ring; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations; Thiosemicarbazones; Semicarbazones; Semicarbazides

Study Officials

• A-Dong Shen, Master

  Beijing Children's Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

• Yu-Jie Qi, Master

  Beijing Children's Hospital of Capital Medical University

  STUDY DIRECTOR

• Wei Zhao, Doctor

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

  STUDY DIRECTOR

Central Study Contacts

A-Dong Shen, Master

CONTACT

+86-010-59616898; 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 8, 2018
• First Posted: August 10, 2018
• Study Start: July 1, 2018
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)