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Trial record 20 of 76 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate"

Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

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ClinicalTrials.gov Identifier: NCT00082173
Recruitment Status : Completed
First Posted : May 4, 2004
Results First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
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
Enrollment 170
Recruitment Details 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 Patients who did not meet enrollment criteria or who did not want to participate in the study were excluded.
Arm/Group Title Experimental Arm Control Arm
Hide Arm/Group Description INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Period Title: Overall Study
Started 74 72
Completed 64 61
Not Completed 10 11
Reason Not Completed
Withdrawal by Subject             3             5
Lost to Follow-up             1             0
Adverse Event             1             0
Culture negative or resistant at baselin             5             6
Arm/Group Title Experimental Arm (Moxi) Control Arm (EMB) Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 74 72 146
Hide Baseline Analysis Population Description
125 had 8-week data (moxifloxacin n=64, ethambutol n=61)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 72 participants 146 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
  97.3%
71
  98.6%
143
  97.9%
>=65 years
2
   2.7%
1
   1.4%
3
   2.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 72 participants 146 participants
32.5  (11.7) 35.7  (12.0) 34.1  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 72 participants 146 participants
Female
34
  45.9%
22
  30.6%
56
  38.4%
Male
40
  54.1%
50
  69.4%
90
  61.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 74 participants 72 participants 146 participants
74 72 146
1.Primary Outcome
Title Proportion of Patients With Sterile Sputum Cultures
Hide Description Proportion of patients with sterile sputum cultures
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Proportion of patients with sterile sputum cultures at week 8
Arm/Group Title Experimental Arm Control Arm
Hide Arm/Group Description:
INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Overall Number of Participants Analyzed 64 61
Measure Type: Number
Unit of Measure: Participants
59 45
2.Secondary Outcome
Title Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications
Hide Description Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
DAIDS Table of Adverse Events
Arm/Group Title Experimental Arm Control Arm
Hide Arm/Group Description:
INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
Overall Number of Participants Analyzed 74 72
Measure Type: Number
Unit of Measure: Participants
0 0
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Arm Control Arm
Hide Arm/Group Description INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
All-Cause Mortality
Experimental Arm Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Arm Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/74 (8.11%)      6/72 (8.33%)    
Cardiac disorders     
Death  1 [1]  3/74 (4.05%)  3 5/72 (6.94%)  5
General disorders     
Hospitalization  1 [2]  3/74 (4.05%)  4 3/72 (4.17%)  3
Renal and urinary disorders     
Grade 4 event  1 [3]  1/74 (1.35%)  1 0/72 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, DAIDS Toxicity Table
[1]
Causes of deaths in the study included: sepsis, gunshots, neoplasm, intracranial hemorrhage, PTB and unknown, none related to study medications
[2]
Hospitalization AEs for this study included:Community acquired pneumonia, abscess, D&C, edema and polyneuropathy, none related to study drugs
[3]
Proteinuria, judged to be not related to study drugs
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental Arm Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/74 (0.00%)      0/72 (0.00%)    
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
Responsible Party: Dr. Richard E. Chaisson, Johns Hopkins University
ClinicalTrials.gov 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