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NCT01863719 · ClinicalTrials.gov registry record · Phase 1
Aerosolized and Intravenous Colistin in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01863719 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants.
The verdict
NCT01863719, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Colistin is amphipathic, cannot be absorbed from the gastrointestinal tract and is administered intramuscularly, intravenously (IV) or via inhalation. In the case of pneumonia, aerosolized route of administration is favorable as it presumably delivers a high concentration of drug directly to the infection site. Colistimethate sodium is an FDA approved drug, however, its aerosolized use represents a new method of administration not currently FDA-approved in the United States. In this proposal, the inactive prodrug colistimethate sodium has been selected to use for aerosolization as it is better tolerated than colistin sulphate. It is a randomized, open-labeled Phase 1 trial of aerosolized and/or IV formulations of colistin as multiple doses over seven days. The primary objective of this trial is to evaluate the safety and tolerability of multiple doses of aerosolized and intravenous colistimethate sodium separately or in combination in healthy adult subjects.
Interventions
- DRUG Colistimethate sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2013-08-06 |
| Est. Completion | 2017-05-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01863719
The ClinicalTrials.gov registry entry for NCT01863719 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Colistimethate sodium is the first listed.
NCT01863719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01863719 about?
NCT01863719 is a clinical study titled "Aerosolized and Intravenous Colistin in Healthy Adults". Colistin is amphipathic, cannot be absorbed from the gastrointestinal tract and is administered intramuscularly, intravenously (IV) or via inhalation. In the case of pneumonia, aerosolized route of administration is favorable as it presumably delivers a high concentration of drug directly to the inf...
What is the current status of trial NCT01863719?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2013-08-06. Estimated completion is 2017-05-04.
What interventions are being tested in trial NCT01863719?
The interventions under investigation include: Colistimethate sodium (DRUG).
Who is sponsoring clinical trial NCT01863719?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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