Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT01329250
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01329250
Study Brief:
Protocol Section:
NCT01329250