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| Name | Class |
|---|---|
| Shandong University | OTHER |
| Hopital Universitaire Robert-Debre | OTHER |
| Rennes University Hospital | OTHER |
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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.
1.Establish population pharmacokinetic (PPK) models of each anti-tuberculsis drug in children by nonlinear mixed effect modeling (NONMEM).
2.Evaluation of the clinical feasibility and safety of individualized dosing.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-tuberculosis drug | Drug | The intervention drugs are prescribed by treating caregiver |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentration (Cmax) | Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| absorption rate constant (ka) | Ka is the rate constant of drug absorption. |
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Inclusion Criteria:
Exclusion Criteria:
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Children with anti-tuberculosis therapies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A-Dong Shen, Master | Contact | +86-010-59616898 | shenad16@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital of Capital Medical University | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26289222 | Background | 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. | |
| 19961873 | 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. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D000995 | Antitubercular Agents |
| D007538 | Isoniazid |
| D012293 | Rifampin |
| D011718 | Pyrazinamide |
| D004977 | Ethambutol |
| D064704 | Levofloxacin |
| D000077266 | Moxifloxacin |
| D000077734 | Gatifloxacin |
| D000583 | Amikacin |
| D002207 | Capreomycin |
| D007612 | Kanamycin |
| D013307 | Streptomycin |
| D005000 | Ethionamide |
| D003523 | Cycloserine |
| C100142 | terizidone |
| D002991 | Clofazimine |
| C493870 | bedaquiline |
| C516022 | OPC-67683 |
| D010131 | Aminosalicylic Acid |
| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
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whole blood and plasma
| up to 4 weeks |
| 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 |
| half-life (t1/2) | Half-life is the time required for a quantity to reduce to half its initial value. | up to 4 weeks |
| Wei Zhao, Doctor | Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital | Study Director |
| 13679531 | 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. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D013828 | Thioacetazone |
| D020164 |
| Chemical Actions and Uses |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011719 | Pyrazines |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D010619 | Phenazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013882 | Thiosemicarbazones |
| D012664 | Semicarbazones |
| D012663 | Semicarbazides |