Salivary Therapeutic Drug Monitoring of Anti-Tuberculosis Drugs
NCT ID: NCT03080012
Last Updated: 2018-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2017-03-07
2018-05-02
Brief Summary
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Detailed Description
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The study is an observational cohort study with adult tuberculosis patients as subjects. The drugs that are studied are isoniazid, rifampicin, ethambutol, pyrazinamide, moxifloxacin, amikacin, kanamycin, capreomycin, ethionamide, prothionamide, cycloserine, terizidone, linezolid, clofazimine, bedaquiline, delamanid, p-aminosalicylic acid (PAS), imipenem-cilastatin, meropenem, ertapenem, amoxicillin-clavulanate and thioacetazone.
Saliva samples will be taken simultaneously with blood samples for standard TDM. Serum/plasma and saliva drug concentrations will be determined with a validated LC-MS/MS (liquid chromatography-tandem mass spectrometry) method. The correlation and linearity between saliva and plasma/serum concentrations will be tested. The saliva-plasma or serum ratio based on area under the time-concentration curve (AUC) is calculated for the investigated anti-TB drugs. Also pharmacokinetic parameters in serum/plasma and saliva will be calculated and compared to provide a complete image of pharmacokinetics of the anti-TB drugs in saliva.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Saliva sampling
Stimulated saliva samples are taken using cotton rolls.
Plasma/serum sampling
Simultaneously with saliva sampling.
Eligibility Criteria
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Inclusion Criteria
* Patient is treated with anti-tuberculosis drugs included in study
* Patient receives Therapeutic Drug Monitoring (TDM) in routine care
* Patient signed informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Jan-Willem C Alffenaar
PhD, PharmD
Principal Investigators
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Jan-Willem Alffenaar, PhD, PharmD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen (UMCG) Beatrixoord
Haren, Provincie Groningen, Netherlands
Countries
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References
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van den Elsen SHJ, Akkerman OW, Wessels M, Jongedijk EM, Ghimire S, van der Werf TS, Bolhuis MS, Touw DJ, Alffenaar JC. Dose optimisation of first-line tuberculosis drugs using therapeutic drug monitoring in saliva: feasible for rifampicin, not for isoniazid. Eur Respir J. 2020 Oct 22;56(4):2000803. doi: 10.1183/13993003.00803-2020. Print 2020 Oct. No abstract available.
van den Elsen SHJ, Akkerman OW, Jongedijk EM, Wessels M, Ghimire S, van der Werf TS, Touw DJ, Bolhuis MS, Alffenaar JC. Therapeutic drug monitoring using saliva as matrix: an opportunity for linezolid, but challenge for moxifloxacin. Eur Respir J. 2020 May 7;55(5):1901903. doi: 10.1183/13993003.01903-2019. Print 2020 May. No abstract available.
van den Elsen SHJ, Akkerman OW, Huisman JR, Touw DJ, van der Werf TS, Bolhuis MS, Alffenaar JC. Lack of penetration of amikacin into saliva of tuberculosis patients. Eur Respir J. 2018 Jan 11;51(1):1702024. doi: 10.1183/13993003.02024-2017. Print 2018 Jan. No abstract available.
Other Identifiers
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SALIV-01
Identifier Type: -
Identifier Source: org_study_id
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