Pharmacokinetics and safety of moxifloxacin; a dose escalation in patients with tuberculosis
- Conditions
- tuberculosis10028440
- Registration Number
- NL-OMON36271
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1) Patients with TB, with Mycobacterium tuberculosis (or M. africanum) by culture
2) Starting treatment with MFX in a dose of 400 mg as part of their TB treatment
1) Contra-indication for moxifloxacin; baseline QTc-interval > 450 msec
2) History of resuscitation
3) History of ventricular tachycardia (including Torsades de Pointes)
4) Family history of sudden cardiac death or Torsades de Pointes
5) Additional risk factors for Torsades de Pointes (including known heart failure, Left ventricular hypertrophy)
6) Use of concomitant treatment with QT/QTc prolonging drugs (including anti-dysrhythmics class IA and III, antipsychotics, tricyclic antidepressants or the antihistaminic drug terfenadine)
7) Abnormal electrolytes (K, Mg, Na, Ca)
8) Abnormal cardiac repolarisation on screening/baseline ECG
9) History of adverse events to fluoroquinolones
10) HIV co-infection
11) RIF treatment during last 3 weeks before start of the study. After a washout period of 3 weeks the patient can be included.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method