Salivary Therapeutic Drug Monitoring of Anti-Tuberculosis Drugs
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ClinicalTrials.gov Identifier: NCT03080012 |
Recruitment Status :
Completed
First Posted : March 15, 2017
Last Update Posted : November 21, 2018
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Tracking Information | |||||
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First Submitted Date | February 9, 2017 | ||||
First Posted Date | March 15, 2017 | ||||
Last Update Posted Date | November 21, 2018 | ||||
Actual Study Start Date | March 7, 2017 | ||||
Actual Primary Completion Date | May 2, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Saliva-plasma ratio or saliva-serum ratio [ Time Frame: 0, 0.5, 1, 2, 3, 4, 7 hours post-dose for isoniazid, rifampicin, ethambutol and pyrazinamide or 0, 1, 2, 3, 4, 8 hours post-dose for all other drugs ] Ratio of salivary versus blood concentration calculated with salivary and plasma/serum values of area under the time-concentration curve (AUC)
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Salivary Therapeutic Drug Monitoring of Anti-Tuberculosis Drugs | ||||
Official Title | An Observational Study of Salivary Versus Blood Concentrations of Various Anti-Tuberculosis Drugs in Tuberculosis Patients | ||||
Brief Summary | 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. | ||||
Detailed Description | 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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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Tuberculosis patients of University Medical Center Groningen Beatrixoord, Haren, The Netherlands. | ||||
Condition | Tuberculosis | ||||
Intervention |
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Study Groups/Cohorts | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
24 | ||||
Original Estimated Enrollment |
25 | ||||
Actual Study Completion Date | May 2, 2018 | ||||
Actual Primary Completion Date | May 2, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03080012 | ||||
Other Study ID Numbers | SALIV-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Jan-Willem C Alffenaar, University Medical Center Groningen | ||||
Study Sponsor | University Medical Center Groningen | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University Medical Center Groningen | ||||
Verification Date | November 2018 |