Pharmacokinetics and safety of moxifloxacin; a dose escalation in patients with tuberculosis - Pharmacokinetics and safety of moxifloxaci

• Conditions: Tuberculosis; MedDRA version: 12.1Level: LLTClassification code 10044755Term: Tuberculosis

• Registration Number: EUCTR2010-023491-25-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

*Patients with TB, with Mycobacterium tuberculosis (or M. africanum) by culture
*Starting treatment with MFX in a dose of 400 mg as part of their TB treatment

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Contra-indication for MFX; Baseline QTc-interval > 450 msec
* History of resuscitation
* History of ventricular tachycardia (including Torsades de Pointes)
* Family history of sudden cardiac death or Torsades de Pointes
* Additional risk factors for Torsades de Pointes (including known heart failure, Left ventricular hypertrophy)
* Use of concomitant treatment with QT/QTc prolonging drugs (including anti-dysrhythmics class IA and III, antipsychotics, tricyclic antidepressants or the antihistaminic drug terfenadine)
* Abnormal electrolytes (K, Mg, Na, Ca)
* Abnormal cardiac repolarisation on screening/baseline ECG
* History of adverse events to fluoroquinolones
* HIV co-infection
* 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 clinical trial of medicinal product
• Study Design: Not specified