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Completed

NCT Number: NCT02042261

The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study

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.

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Key information

Conditions

Active Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Infectious Diseases, Linköping, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age>18 years, culture verified tuberculosis

Exclusion criteria

Other infectious diseases other than HIV or tuberculosis

Treatment and study plan

Primary outcomes

  1. Rifampicin concentration in relationship to MIC over 10

    Time frame: 2 weeks

Secondary outcomes

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

    Time frame: 1 year

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

    Time frame: 2 and 8 weeks

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

    Time frame: 8 weeks

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

    Time frame: 2 and 8 weeks

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

    Time frame: 2weeks

Sponsors and collaborators

Lead sponsor

Thomas Schon

Other Gov

Collaborators

  • Karolinska University Hospital
  • University Hospital, Linkoeping

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jan 22, 2014
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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