Tuberculosis
Conditions
Interventions
Trade Name: Co-trimoxazole
Pharmaceutical Form: Tablet
Sponsors
UMCG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: TB patients with normal susceptible Mycobacterium tuberculosis (or mycobacterium africanum) by culture admissioned at the tuberculosis center Beatrixoord (UMCG). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients younger than 18 years or older than 64 years. - Pregnancy and breast feeding. - Patients with hypersensitivity to sulfonamide or TMP. - Concomitant treatment with vitamin K antagonist (acenocoumarol). - Patients with preexisting renal dysfunction or concomitant treatment of angiotensin converting enzyme inhibitors and potassium –sparing diuretics) that may exacerbate the hyperkalemic effect of SXT. - Patients treated with methotrexate, phenytoin, sulfonylureas (glibenclamide, gliclazide, glimepiride en tolbutamide) or procainamide hydrochloride. - Patients that have gastrointestinal complaints like diarrhea and vomiting (observed) - Patients that have experienced an adverse effect to SXT or similar antibiotic drugs. - Patients with HIV or AIDS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this prospective clinical trial is to determine the pharmacokinetic variability of co-trimoxazole (960 mg) in patients receiving TB treatment. With these pharmacokinetic parameters, a population model and limited sampling model can be developed retrospectively.;Secondary Objective: The second objective is to calculate the AUC/MIC ratio and T>MIC and to validate drug concentration measurement using DBS by comparing the results of blood samples routinely withdrawn from venous blood versus withdrawn by finger prick and transferred to filter paper to make dried blood spots.;Primary end point(s): Determination of pharmacokinetic parameters of co-trimoxazole and the calculation of the bound and unbound AUC0-24h after administration of co-trimoxazole;Timepoint(s) of evaluation of this end point: On the 4th, 5th or 6th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Calculation of the AUC0-24h/MIC and T>MIC and validation of drug concentration measurement using dried blood spot analysis.;Timepoint(s) of evaluation of this end point: On the 4th, 5th or 6th day. | — |
Countries
Netherlands
Contacts
Public ContactKF&A
UMCG
Outcome results
None listed