CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 290 enrolled
Drug / intervention
POC-PCRother
Likely dose
Not stated in record
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Search/NCT04651712
NCT04651712N/ACompleted

The Effect of a Point-of-care Sputum Specimen Assay on Antibiotic Treatment of Patients Admitted Acutely With Suspected Pneumonia: A Multicenter Randomized Controlled Trial

University of Southern Denmark·interventional·Posted Dec 3, 2020·Updated Sep 14, 2022

In Brief

A clinical study evaluating POC-PCR for Pneumonia, Bacterial. Completed, enrolled 290 participants across 1 site.

Detailed Summary

Antibiotic resistance has been identified by the WHO as one of the biggest threats to the health of the world population. In Denmark, there has been an increasing focus on optimizing antibiotic consumption in recent years, but despite significant efforts, total consumption has increased in the hospital sector, especially regarding consumption and in the use of broad-spectrum antibiotics. Currently, a pneumonia diagnosis is primarily based on clinical symptoms such as cough, shortness of breath, chest pain, fever and sputum production, combined with X-ray of the lungs, relevant blood tests and microbiological analysis of sputum samples. X-ray is however an imprecise diagnostic tool, and sputum assays responses are available after 2 days. Sputum can be cultivated to determine the bacterial agent. However, the sputum samples are often of poor quality and many patients cannot deliver a sample. A recently published Danish study shows, that only half of the patients at the ED have sputum samples collected for culturing and none of them had the antibiotic treatment adjusted based on the microbiological results of the sputum. This study's hypothesis is that point-of-care-polymerase chain reaction (POC-PCR) is superior to standard care on the prescription of targeted pneumonia treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 3, 2020
Enrollment StartMar 1, 2021
Primary CompletionFeb 28, 2022
Study CompletionJun 1, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.6 years ago

Interventions

POC-PCRother

The result of the POC-PCR will be presented by the study assistant to the treating physician within four hours upon admission. The treating physician will along with the result receive a recommended action list, developed by microbiologists.