Pharmacokinetics and Safety of Moxifloxacin

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose (600 mg; 800 mg) of moxifloxacin (MFX). This clinical trial will provide important safety information on MFX in a higher dosage in TB patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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

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.