Tuberculosis Clinical Trial
Official title:
An Observational Study of Salivary Versus Blood Concentrations of Various Anti-Tuberculosis Drugs in Tuberculosis Patients
In tuberculosis patients, salivary concentrations will be compared to plasma/serum concentrations of several anti-tuberculosis drugs. If salivary concentrations correctly represent blood concentrations, this non-invasive sampling of saliva could be used for TDM of the tested drugs.
TDM (Therapeutic Drug Monitoring) with blood samples is already part of the treatment of some
tuberculosis (TB) patients to reduce development of drug resistance and toxic drug
concentrations. Performing TDM with saliva instead of plasma or serum could reduce the burden
of blood sampling. This study examines if this non-invasive sampling of saliva could be used
for TDM of several anti-TB drugs.
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.
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