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