Status:
COMPLETED
Pharmacokinetic Parameters of Co-trimoxazole
Lead Sponsor:
University Medical Center Groningen
Conditions:
Tuberculosis
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
Rationale: Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real challenge as failure in response to treatment and serious side-effects are frequently encountered. ...
Eligibility Criteria
Inclusion
- TB Patients with normal susceptible Mycobacterium tuberculosis
- Patients older than 17 and younger than 64 years.
Exclusion
- Pregnancy or breast feeding
- Patients with hypersensitivity to sulfonamide or trimethoprim
- Concomitant treatment with vitamin K antagonists (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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01832987
Start Date
October 1 2013
End Date
August 1 2014
Last Update
September 16 2014
Active Locations (1)
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1
UMCG - Tuberculosis Center
Groningen, Netherlands