Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

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. Identifier: NCT00082173
Recruitment Status : Completed
First Posted : May 4, 2004
Results First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Information provided by:
Johns Hopkins University

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

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
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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
125 had 8-week data (moxifloxacin n=64, ethambutol n=61)

Reporting Groups
Experimental Arm (Moxi) No text entered.
Control Arm (EMB) No text entered.
Total Total of all reporting groups

Baseline Measures
   Experimental Arm (Moxi)   Control Arm (EMB)   Total 
Overall Participants Analyzed 
[Units: Participants]
 74   72   146 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   72   71   143 
>=65 years   2   1   3 
[Units: Years]
Mean (Standard Deviation)
 32.5  (11.7)   35.7  (12.0)   34.1  (11.9) 
[Units: Participants]
Female   34   22   56 
Male   40   50   90 
Region of Enrollment 
[Units: Participants]
Brazil   74   72   146 

  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

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Richard Chaisson
Organization: Johns Hopkins University
phone: 410-955-1755

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Dr. Richard E. Chaisson, Johns Hopkins University Identifier: NCT00082173     History of Changes
Other Study ID Numbers: FD-R-002135-01
First Submitted: April 30, 2004
First Posted: May 4, 2004
Results First Submitted: March 26, 2013
Results First Posted: May 22, 2013
Last Update Posted: May 22, 2013