Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
9 participants
INTERVENTIONAL
2011-05-31
2016-08-31
Brief Summary
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Detailed Description
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For this purpose, twenty tuberculosis patients will start on a standard dose of MFX 400 mg once daily. After 8 days the dose will be increased to 600 mg once daily and on the 15th day of treatment, the dose of MFX will be escalated to 800 mg. In patients who have been treated with rifampicin (RIF) in the past three weeks prior to start of MFX treatment an additional washout period of 3 weeks to reduce the rifampicin induced enzymatic activity will precede the dose escalation.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Moxifloxacin
Moxifloxacinin escalating dose
Moxifloxacin
Patients will start on a standard dose of MFX 400 mg once daily. After 8 days the dose will be increased to 600 mg once daily and on the 15th day of treatment, the dose of MFX will be escalated to 800 mg. In patients who have been treated with rifampicin (RIF) in the past three weeks prior to start of MFX treatment an additional washout period of 3 weeks to reduce the rifampicin induced enzymatic activity will precede the dose escalation.
Interventions
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Moxifloxacin
Patients will start on a standard dose of MFX 400 mg once daily. After 8 days the dose will be increased to 600 mg once daily and on the 15th day of treatment, the dose of MFX will be escalated to 800 mg. In patients who have been treated with rifampicin (RIF) in the past three weeks prior to start of MFX treatment an additional washout period of 3 weeks to reduce the rifampicin induced enzymatic activity will precede the dose escalation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Starting treatment with MFX in a dose of 400 mg as part of their TB treatment
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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JWC Alffenaar
PharmD, PhD
Principal Investigators
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Jos GW Kosterink, PharmD, PhD
Role: STUDY_CHAIR
Univeristy Medical Center Groningen
Jan-Willem C Alffenaar, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Other Identifiers
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MFX468
Identifier Type: -
Identifier Source: org_study_id