Trial · NCT00396084
Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
NCT00396084, Phase 1, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2009-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis. Trials, record NCT00396084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00396084
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
- NCT number
- NCT00396084
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Tuberculosis
- Interventions
- Gatifloxacin, Isoniazid, Levofloxacin, Linezolid, Moxifloxacin
- First posted
- 2006-11-06
- Last updated
- 2018-11-08
- Results first posted
- 2009-06-25
- 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.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Study drug administration duration - 7 days monotherapy | The adjusted area under the curve (aAUC) for sputum colony forming units (cfu) for each day on treatment was calculated. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration. |
| Primary | Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Fluoroquinolones/Isoniazid (INH) Comparison | Day 0 to Day 2 Monotherapy | Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum colony forming units (cfu) (expressed in log10 units) during the first 2 days of monotherapy. |
| Primary | Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Fluoroquinolones/Isoniazid (INH) Comparison | Day 2 to Day 7 Monotherapy | The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7. |
| Primary | Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Study drug administration duration - 7 days monotherapy | The adjusted area under the curve (aAUC) for sputum colony forming unit (cfu) for each day on treatment was calculated for patients in the INH arm and those in the Linezolid once daily and Linezolid twice daily arms. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration. |
| Primary | Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Linezolid Once Daily/Linezolid Twice Daily/Isoniazid (INH) Comparison | Day 0 to Day 2 Monotherapy | Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum cfu (expressed in log10 units) during the first 2 days of monotherapy. Mean values for the 3 treatment groups were compared. |
| Primary | Difference in Sputum Bacillary Loads: Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Linezolid Once Daily/Linezolid Twice Daily/INH Comparison | Day 2 to Day 7 Monotherapy | The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7. |
| Secondary | Sputum mRNA Clearance Rate - Results Are Pending. | Study drug administration duration | |
| Secondary | Sputum Cytokine Proteins - Results Are Pending. | Study drug administration duration | |
| Secondary | Maximum Plasma Drug Concentration (Cmax) | Day 5 (7 time points) | Maximum plasma concentration, given sampling scheme |
| Secondary | Time to Maximum Plasma Drug Concentration (Tmax) and Half-life | Day 5 (7 time points) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Study drug administration duration - 7 days monotherapy | The aAUC was calculated for 10 subjects per treatment arm (n=40). | Percentage | MEAN |
| SECONDARY | Sputum mRNA Clearance Rate - Results Are Pending. | Study drug administration duration | |||
| SECONDARY | Sputum Cytokine Proteins - Results Are Pending. | Study drug administration duration | |||
| SECONDARY | Maximum Plasma Drug Concentration (Cmax) | Day 5 (7 time points) | Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling. | ug/ml | MEDIAN |
| PRIMARY | Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Fluoroquinolones/Isoniazid (INH) Comparison | Day 0 to Day 2 Monotherapy | Early bactericidal activity (EBA 0-2) was calculated for 10 subjects per treatment arm (n=40). | log10 cfu/ml/day | MEAN |
| PRIMARY | Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Fluoroquinolones/Isoniazid (INH) Comparison | Day 2 to Day 7 Monotherapy | A total of 38 patients were analyzed for Early Bactericidal Activity (EBA) Days 2-7. One patient in the moxifloxacin arm discontinued the study drug after 4 days. One patient in the INH arm discontinued the study drug after 6 days. | log10 cfu/ml/day | MEAN |
| PRIMARY | Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Study drug administration duration - 7 days monotherapy | The aAUC was calculated for 29 patients. One patient in the linezolid twice daily arm withdrew after randomization before receiving any doses of study drug. | Percentage | MEAN |
| PRIMARY | Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Linezolid Once Daily/Linezolid Twice Daily/Isoniazid (INH) Comparison | Day 0 to Day 2 Monotherapy | EBA 0-2 comparisons across groups were done for 29 patients. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug. | log10 cfu/ml/day | MEAN |
| SECONDARY | Time to Maximum Plasma Drug Concentration (Tmax) and Half-life | Day 5 (7 time points) | Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling. | hours | MEDIAN |
| SECONDARY | Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC) | Day 5 (7 time points) | Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling. | ug/ml | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Gatifloxacin 400 mg/Day | Day 1 | 0.98 | Standard Deviation 0.03 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Levofloxacin 1000 mg/Day | Day 1 | 0.98 | Standard Deviation 0.03 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Moxifloxacin 400 mg/Day | Day 1 | 0.96 | Standard Deviation 0.04 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Isoniazid (INH) 300 mg/Day | Day 1 | 0.95 | Standard Deviation 0.03 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Gatifloxacin 400 mg/Day | Day 2 | 0.96 | Standard Deviation 0.03 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Levofloxacin 1000 mg/Day | Day 2 | 0.95 | Standard Deviation 0.05 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Moxifloxacin 400 mg/Day | Day 2 | 0.94 | Standard Deviation 0.06 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Isoniazid (INH) 300 mg/Day | Day 2 | 0.90 | Standard Deviation 0.04 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Gatifloxacin 400 mg/Day | Day 3 | 0.92 | Standard Deviation 0.05 | Percentage |
| Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC) | Levofloxacin 1000 mg/Day | Day 3 | 0.91 | Standard Deviation 0.07 | Percentage |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gatifloxacin 400 mg/Day | 10 | |
| Overall Study | STARTED | Levofloxacin 1000 mg/Day | 10 | |
| Overall Study | STARTED | Linezolid 600 mg / Once Daily | 10 | |
| Overall Study | STARTED | Linezolid 600 mg / Twice Daily | 10 | |
| Overall Study | STARTED | Moxifloxacin 400 mg/Day | 10 | |
| Overall Study | STARTED | Isoniazid (INH) 300 mg/Day | 20 | |
| Overall Study | COMPLETED | Gatifloxacin 400 mg/Day | 10 | |
| Overall Study | COMPLETED | Levofloxacin 1000 mg/Day | 10 | |
| Overall Study | COMPLETED | Linezolid 600 mg / Once Daily | 10 | |
| Overall Study | COMPLETED | Linezolid 600 mg / Twice Daily | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acne | Skin and subcutaneous tissue disorders | Gatifloxacin 400 mg/Day | 3 | 10 | 3 |
| other | Acne | Skin and subcutaneous tissue disorders | Levofloxacin 1000 mg/Day | 0 | 10 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Linezolid 600 mg / Once Daily | 0 | 10 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Linezolid 600 mg / Twice Daily | 0 | 10 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Moxifloxacin 400 mg/Day | 0 | 10 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Isoniazid (INH) 300 mg/Day | 0 | 20 | 0 |
| other | Chest Pain | Respiratory, thoracic and mediastinal disorders | Gatifloxacin 400 mg/Day | 2 | 10 | 2 |
| other | Chest Pain | Respiratory, thoracic and mediastinal disorders | Levofloxacin 1000 mg/Day | 0 | 10 | 0 |
| other | Chest Pain | Respiratory, thoracic and mediastinal disorders | Linezolid 600 mg / Once Daily | 0 | 10 | 0 |
| other | Chest Pain | Respiratory, thoracic and mediastinal disorders | Linezolid 600 mg / Twice Daily | 0 | 10 | 0 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gatifloxacin 400 mg/Day | ||
| Total, all-cause mortality | Levofloxacin 1000 mg/Day | ||
| Total, all-cause mortality | Linezolid 600 mg / Once Daily | ||
| Total, all-cause mortality | Linezolid 600 mg / Twice Daily | ||
| Total, all-cause mortality | Moxifloxacin 400 mg/Day | ||
| Total, all-cause mortality | Isoniazid (INH) 300 mg/Day | ||
| Total, other adverse events | Gatifloxacin 400 mg/Day | 8 | 10 |
| Total, other adverse events | Levofloxacin 1000 mg/Day | 7 | 10 |
| Total, other adverse events | Linezolid 600 mg / Once Daily | 8 | 10 |
| Total, other adverse events | Linezolid 600 mg / Twice Daily | 5 | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00396084
GET https://conductscience.org/api/trials/v1/NCT00396084/outcomes?page=2