NCT02042261

Brief Summary

Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance. This concept is defined as therapeutic drug monitoring (TDM). In this pilot study our hypothesis is that the ratio between MIC and drug concentration data is correlated to the bacterial load measured as time to positive liquid culture (TTP). In two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12 weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate samples. Clinical follow up according to WHO criteria will be performed 1 year after completion of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

3.8 years

First QC Date

January 20, 2014

Last Update Submit

March 1, 2016

Conditions

Active Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Rifampicin concentration in relationship to MIC over 10

    2 weeks

Secondary Outcomes (5)

  • Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2

    1 year

  • Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2

    2 and 8 weeks

  • TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2

    8 weeks

  • Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC)

    2 and 8 weeks

  • Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC)

    2weeks

Eligibility Criteria

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

Newly diagnosed patients with culture verified tuberculosis

You may qualify if:

  • Age\>18 years, culture verified tuberculosis

You may not qualify if:

  • Other infectious diseases other than HIV or tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Infectious Diseases

Linköping, Linköping, 581 85, Sweden

Location

Dept of Infectious Diseases, TB-unit, Karolinska Hospital

Stockholm, Stockholm County, 17671, Sweden

Location

Related Publications (1)

  • Niward K, Davies Forsman L, Bruchfeld J, Chryssanthou E, Carlstrom O, Alomari T, Carlsson B, Pohanka A, Mansjo M, Jonsson Nordvall M, Johansson AG, Eliasson E, Werngren J, Paues J, Simonsson USH, Schon T. Distribution of plasma concentrations of first-line anti-TB drugs and individual MICs: a prospective cohort study in a low endemic setting. J Antimicrob Chemother. 2018 Oct 1;73(10):2838-2845. doi: 10.1093/jac/dky268.

    PMID: 30124844DERIVED

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Study Officials

  • Katarina Niward, MD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 22, 2014

Study Start

January 1, 2012

Primary Completion

November 1, 2015

Study Completion

March 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

SE(2)