Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
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ClinicalTrials.gov Identifier: NCT00396084 |
Recruitment Status :
Completed
First Posted : November 6, 2006
Results First Posted : June 25, 2009
Last Update Posted : November 8, 2018
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Tuberculosis |
Interventions |
Drug: Gatifloxacin Drug: Isoniazid Drug: Levofloxacin Drug: Linezolid Drug: Moxifloxacin |
Enrollment | 70 |
Participant Flow
Recruitment Details | Screening for the trial began in February 2004 in Vitória, Brazil. Non-HIV infected adults aged 18-65 years with suspected pulmonary tuberculosis (TB) were recruited at local TB posts and the Hospital Universitario Cassiano Antonio de Moraes of the Universidade Federal do Espírito Santo (UFES) in Vitória. Enrollment was completed in October 2007. |
Pre-assignment Details | A total of 113 adults with suspected pulmonary TB were evaluated for study participation. Forty-three were excluded because they did not meet the eligibility criteria, leaving a total of 70 patients. |
Arm/Group Title | Gatifloxacin 400 mg/Day | Levofloxacin 1000 mg/Day | Linezolid 600 mg / Once Daily | Linezolid 600 mg / Twice Daily | Moxifloxacin 400 mg/Day | Isoniazid (INH) 300 mg/Day |
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Gatifloxacin 400 mg/day x 7 days | Levofloxacin 1000 mg/day x 7days | Linezolid 600 mg/once daily x 7days | Linezolid 600 mg twice daily x 7 days | Moxifloxacin 400 mg/day x 7 days | Isoniazid (INH) 300 mg/day x 7 days |
Period Title: Overall Study | ||||||
Started | 10 | 10 | 10 | 10 | 10 | 20 |
Completed | 10 | 10 | 10 | 9 | 9 | 18 |
Not Completed | 0 | 0 | 0 | 1 | 1 | 2 |
Reason Not Completed | ||||||
Adverse Event | 0 | 0 | 0 | 0 | 1 | 2 |
Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Gatifloxacin 400 mg/Day | Levofloxacin 1000 mg/Day | Linezolid 600 mg / Once Daily | Linezolid 600 mg / Twice Daily | Moxifloxacin 400 mg/Day | Isoniazid (INH) 300 mg/Day | Total | |
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Gatifloxacin 400 mg/day x 7 days | Levofloxacin 1000 mg/day x 7days | Linezolid 600 mg/once daily x 7days | Linezolid 600 mg twice daily x 7 days | Moxifloxacin 400 mg/day x 7 days | Isoniazid (INH) 300 mg/day x 7 days | Total of all reporting groups | |
Overall Number of Baseline Participants | 10 | 10 | 10 | 10 | 10 | 20 | 70 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 20 participants | 70 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
10 100.0%
|
10 100.0%
|
10 100.0%
|
10 100.0%
|
10 100.0%
|
20 100.0%
|
70 100.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
||||||||
Number Analyzed | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 20 participants | 70 participants | |
34.5
(27.0 to 40.0)
|
43.5
(42.0 to 46.0)
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33.5
(23.0 to 42.0)
|
45.0
(39.0 to 48.0)
|
35.0
(25.0 to 37.0)
|
33.0
(23.0 to 43.5)
|
35.0
(26.0 to 44.0)
|
||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 20 participants | 70 participants | |
Female |
1 10.0%
|
2 20.0%
|
2 20.0%
|
2 20.0%
|
1 10.0%
|
3 15.0%
|
11 15.7%
|
|
Male |
9 90.0%
|
8 80.0%
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8 80.0%
|
8 80.0%
|
9 90.0%
|
17 85.0%
|
59 84.3%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Brazil | Number Analyzed | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 20 participants | 70 participants |
10 | 10 | 10 | 10 | 10 | 20 | 70 |
Outcome Measures
Adverse Events
Limitations and Caveats
The small sample size had limited power to detect small differences in EBA between study arms even though we enrolled patients with smear-positive TB and high sputum bacillary burden to improve chances of detecting differences between treatment arms.
More Information
Results Point of Contact
Name/Title: | John L. Johnson, M.D. |
Organization: | Case Western Reserve University, Tuberculosis Research Unit |
Phone: | (216) 368-1949 |
EMail: | jlj@case.edu |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00396084 |
Other Study ID Numbers: |
01-553 |
First Submitted: | November 3, 2006 |
First Posted: | November 6, 2006 |
Results First Submitted: | November 19, 2008 |
Results First Posted: | June 25, 2009 |
Last Update Posted: | November 8, 2018 |