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NCT02918409 · ClinicalTrials.gov registry record · Phase 4
IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy
A Phase 4 study, sponsored by National Jewish Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT02918409 is a Phase 4 study that has completed, run by National Jewish Health. The registered enrollment target is 51 participants.
The verdict
NCT02918409, a Phase 4 study, has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this study is to find the safest and most effective way to administer IV antibiotics to treat acute pulmonary exacerbations (APEs) in patients with cystic fibrosis (CF) that are caused by pathogens, like Pseudomonas aeruginosa. This study will test the safety and effectiveness of two commonly prescribed IV antibiotics: tobramycin and colistin. Though regularly used, not much is known about how these drugs compare with each other in terms of their toxicities, both during short term treatment of an APE and after many treatment courses with these drugs over many years. There are currently no guidelines on the safest and most effective antibiotics to use when treating APEs. We will study kidney function, sputum cultures, and treatment outcomes in patients receiving routine administration of one of these two IV antibiotics. We will also test these outcomes in patients receiving a less frequent dosing schedule for IV colistin. The hope is that this new schedule for IV colistin, which is twice a day and adjusted based on blood and urine tests, will reduce harmful side effects, such as kidney damage, while still being a powerful treatment against CF microbial pathogens.
Interventions
- DRUG Tobramycin
- DRUG Colistin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2016-08-26 |
| Est. Completion | 2021-11-22 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02918409
The ClinicalTrials.gov registry entry for NCT02918409 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Jewish Health, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tobramycin is the first listed.
NCT02918409 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02918409 about?
NCT02918409 is a clinical study titled "IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy". The purpose of this study is to find the safest and most effective way to administer IV antibiotics to treat acute pulmonary exacerbations (APEs) in patients with cystic fibrosis (CF) that are caused by pathogens, like Pseudomonas aeruginosa. This study will test the safety and effectiveness of two ...
What is the current status of trial NCT02918409?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2016-08-26. Estimated completion is 2021-11-22.
What interventions are being tested in trial NCT02918409?
The interventions under investigation include: Tobramycin (DRUG), Colistin (DRUG).
Who is sponsoring clinical trial NCT02918409?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
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