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NCT03341273 · ClinicalTrials.gov registry record · NA
Placebo-Controlled Trial of Antibiotic Therapy in Adults With Suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin Level
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- NA
- Development phase
- 514
- Enrollment target
NCT03341273 is a NA study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 514 participants.
The verdict
NCT03341273, a NA study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- NA
- Development phase
- 514 participants
- Enrollment target
Study Summary
This is a randomized, double-blinded, placebo-controlled, non-inferiority multicenter clinical trial of azithromycin vs. placebo in adults presenting as outpatients with suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin (PCT) level of \< / = 0.25 ng/mL, as a strategy for reducing antibiotic prescriptions. The study is designed to compare the efficacy of azithromycin versus placebo on Day 5 (i.e., after 4 days of treatment) in subjects with suspect LRTI and PCT levels of \< / = 0.25 ng/mL at enrollment using a non-inferiority approach. The study will recruit potential subjects 18 years of age or older who are suspected to have LRTI. The enrollment cap will be 840 participants, for the goal of approximately 674 randomized participants who will be randomized 1:1 to receive oral azithromycin or placebo for five days. Randomized subjects will have efficacy measured from the time of the first dose of study drug (Day 1) through approximately Day 28. The Primary Objective is to compare the efficacy of azithromycin versus placebo on Day 5 (i.e., after 4 days of treatment) in subjects with suspect LRTI and PCT levels of \< / = 0.25 ng/mL at enrollment using a non-inferiority approach.
Interventions
- OTHER Placebo
- DRUG Azithromycin
- DEVICE VIDAS B.R.A.H.M.S Procalcitonin Test (PCT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 514 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2020-08-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03341273
The ClinicalTrials.gov registry entry for NCT03341273 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 514 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 3 interventions - of which Placebo is the first listed.
NCT03341273 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03341273 about?
NCT03341273 is a clinical study titled "Placebo-Controlled Trial of Antibiotic Therapy in Adults With Suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin Level". This is a randomized, double-blinded, placebo-controlled, non-inferiority multicenter clinical trial of azithromycin vs. placebo in adults presenting as outpatients with suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin (PCT) level of \< / = 0.25 ng/mL, as a strategy for reducing ...
What is the current status of trial NCT03341273?
This trial is currently terminated. It is a NA study. The enrollment target is 514 participants. The study started on 2017-12-08. Estimated completion is 2020-08-15.
What interventions are being tested in trial NCT03341273?
The interventions under investigation include: Placebo (OTHER), Azithromycin (DRUG), VIDAS B.R.A.H.M.S Procalcitonin Test (PCT) (DEVICE).
Who is sponsoring clinical trial NCT03341273?
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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