This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00082173
First received: April 30, 2004
Last updated: March 26, 2013
Last verified: March 2013
Results First Received: March 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tuberculosis
Intervention: Drug: Moxifloxacin

  Participant Flow


  Baseline Characteristics
  Hide 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
  Description
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 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   72   71   143 
>=65 years   2   1   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.5  (11.7)   35.7  (12.0)   34.1  (11.9) 
Gender 
[Units: Participants]
     
Female   34   22   56 
Male   40   50   90 
Region of Enrollment 
[Units: Participants]
     
Brazil   74   72   146 


  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