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NCT00396084 · ClinicalTrials.gov registry record · Phase 1
Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
A Phase 1 study of Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 2
- Study locations
NCT00396084: Completed Phase 1 study of Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00396084 is a Phase 1 study of Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 70 participants, below the 932-participant average among 29 other Tuberculosis trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00396084, a Phase 1 study of Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin, and moxifloxacin. All are approved by the Brazilian health authorities to treat infections caused by germs other than TB. Seventy human immunodeficiency virus (HIV)-negative adults, aged 18-65 years, who have been newly diagnosed with pulmonary (lung) TB, will participate in this study. Study volunteers will be given one of the 4 study drugs or a comparison antibiotic, Isoniazid, which has been used around the world as a standard of care treatment for TB. Volunteers will stay in the hospital for 10 days and be given a study antibiotic 7 of those days. Blood and saliva samples will be taken. Six weeks later, volunteers will return for a final health check. All volunteers will receive 6 months of standard tuberculosis treatment.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG Isoniazid
- DRUG Levofloxacin
- DRUG Linezolid
- DRUG Gatifloxacin
Study Locations (2)
California
- San Francisco General Hospital - Pulmonary and Critical Care Medicine - San Francisco
Espírito Santo
- Universidade Federal do Espirito Santo - Duke Hubert-Yeargan Center - Vitória
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2004-02-10 |
| Est. Completion | 2007-12-28 |
| Phase | Phase 1 |
What the finished NCT00396084 record still lists
NCT00396084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 932-participant average among 29 other Tuberculosis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Tuberculosis appearing as the primary indexed condition, and to 5 interventions - of which Moxifloxacin is the first listed.
NCT00396084 reports a single indexed study location in California, Espírito Santo.
Frequently Asked Questions
What is clinical trial NCT00396084 about?
NCT00396084 is a clinical study titled "Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis". This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin, and moxifloxacin. All are approved by the Brazilian health authorities to treat infections caused by germs other than TB. ...
What is the current status of trial NCT00396084?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2004-02-10. Estimated completion is 2007-12-28.
What conditions does trial NCT00396084 study?
This clinical trial studies the following conditions: Tuberculosis.
What interventions are being tested in trial NCT00396084?
The interventions under investigation include: Moxifloxacin (DRUG), Isoniazid (DRUG), Levofloxacin (DRUG), Linezolid (DRUG), Gatifloxacin (DRUG).
Who is sponsoring clinical trial NCT00396084?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00396084 being conducted?
This trial has 2 study locations across California, Espírito Santo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00396084's enrollment target sits among peer trials
70 20th of 29 higher than 10 of 29 other Tuberculosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberculosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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