- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Linköping, Sverige, 581 85
- Dept of Infectious Diseases
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Stockholm, Sverige, 17671
- Dept of Infectious Diseases, TB-unit, Karolinska Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Age>18 years, culture verified tuberculosis
Exclusion Criteria:
Other infectious diseases other than HIV or tuberculosis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rifampicin concentration in relationship to MIC over 10
Tidsramme: 2 weeks
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2 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2
Tidsramme: 1 year
|
1 year
|
Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2
Tidsramme: 2 and 8 weeks
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2 and 8 weeks
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TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2
Tidsramme: 8 weeks
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8 weeks
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Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC)
Tidsramme: 2 and 8 weeks
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2 and 8 weeks
|
Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC)
Tidsramme: 2weeks
|
2weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Katarina Niward, MD, Linkoeping University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TB-TDM
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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