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NCT01375049 · ClinicalTrials.gov registry record · Phase 2
Aztreonam Lysine for Pseudomonas Infection Eradication Study
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT01375049 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 105 participants.
The verdict
NCT01375049, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA. The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).
Interventions
- DRUG Aztreonam for Inhalation Solution (AZLI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01375049
The ClinicalTrials.gov registry entry for NCT01375049 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aztreonam for Inhalation Solution (AZLI) is the first listed.
NCT01375049 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01375049 about?
NCT01375049 is a clinical study titled "Aztreonam Lysine for Pseudomonas Infection Eradication Study". This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Sol...
What is the current status of trial NCT01375049?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2011-08. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01375049?
The interventions under investigation include: Aztreonam for Inhalation Solution (AZLI) (DRUG).
Who is sponsoring clinical trial NCT01375049?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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