NCT03080012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

March 7, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

February 9, 2017

Last Update Submit

November 20, 2018

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Saliva-plasma ratio or saliva-serum ratio

    Ratio of salivary versus blood concentration calculated with salivary and plasma/serum values of area under the time-concentration curve (AUC)

    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

Secondary Outcomes (9)

  • Salivary drug concentration

    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

  • Plasma/serum drug concentration

    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

  • Area under the time-concentration curve (AUC) in saliva and plasma/serum

    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

  • Peak concentration (Cmax) in saliva and plasma/serum

    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

  • Time of peak concentration (Tmax) in saliva and plasma/serum

    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

  • +4 more secondary outcomes

Interventions

Saliva samplingOTHER

Stimulated saliva samples are taken using cotton rolls.

Plasma/serum samplingOTHER

Simultaneously with saliva sampling.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tuberculosis patients of University Medical Center Groningen Beatrixoord, Haren, The Netherlands.

You may qualify if:

  • Tuberculosis is confirmed by culture or molecular test
  • Patient is treated with anti-tuberculosis drugs included in study
  • Patient receives Therapeutic Drug Monitoring (TDM) in routine care
  • Patient signed informed consent

You may not qualify if:

  • Patient with severe problems in the oral cavity, making saliva sampling painful

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen (UMCG) Beatrixoord

Haren, Provincie Groningen, 9751ND, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 32398308DERIVED

  • 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.

    PMID: 31980497DERIVED

  • 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.

    PMID: 29326320DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Jan-Willem Alffenaar, PhD, PharmD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, PharmD

Study Record Dates

First Submitted

February 9, 2017

First Posted

March 15, 2017

Study Start

March 7, 2017

Primary Completion

May 2, 2018

Study Completion

May 2, 2018

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations

NL(1)