We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00082173
First Posted: May 4, 2004
Last Update Posted: May 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johns Hopkins University
Results First Submitted: March 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tuberculosis
Intervention: Drug: Moxifloxacin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects with respiratory symptoms suggestive of TB were recruited from the HUCFF outpatient TB clinic as well as other local TB clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who did not meet enrollment criteria or who did not want to participate in the study were excluded.

Reporting Groups
  Description
Experimental Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
Control Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks

Participant Flow:   Overall Study
    Experimental Arm   Control Arm
STARTED   74   72 
COMPLETED   64   61 
NOT COMPLETED   10   11 
Withdrawal by Subject                3                5 
Lost to Follow-up                1                0 
Adverse Event                1                0 
Culture negative or resistant at baselin                5                6 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Patients With Sterile Sputum Cultures   [ Time Frame: 8 weeks ]

2.  Secondary:   Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information