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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: Clinical Trial NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical improvement at Day 5 Visit is defined as fulfilling all of the following criteria: 1. Improvement in at least two symptoms present at enrollment or one symptom and at least one vital sign abnormality present at enrollment 2. Absence of deterioration in any qualifying symptom or new vital sign abnormality not present at enrollment 3. Absence of fever in the day preceding or at the D5V 4. No medically attended visit to an ambulatory medical facility or hospitalization for persistent or w
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 |
Why NCT03341273 stopped before completion
NCT03341273 is an interventional study that assigns participants to a tested intervention. The registered 514 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03341273 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03341273's enrollment target sits among peer trials
514 192nd of 2000 higher than 1,809 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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