Evaluation of a New Molecular Point-of-Care-Testing (POCT) System to Shorten Antibiotic Treatment Duration in Hospitalized Patients with Lower Respiratory Tract Infections: A Randomized Clinical Trial

Background: Many unnecessary antibiotics are prescribed to patients with viral lower respiratory tract infections (LRTIs). The FilmArray® Respiratory Panel is a new molecular point-of-care testing (POCT) procedure, which provides faster and comprehensive identification of viruses and atypical pathogens. But whether POCT could potentially help optimize antibiotics use for LRTIs remains a controversial topic. Methods: In this single-center, open-label, randomized controlled study, hospitalized adult patients diagnosed with community-acquired pneumonia, acute exacerbation of chronic obstructive pulmonary disease, or acute exacerbation of bronchiectasis were enrolled in the study. Patients were randomly assigned to the POCT group or the routine real-time PCR assays (control) group. The primary outcome was the duration of intravenous antibiotics used during hospitalization. The secondary outcomes included the length of hospital stay and the total cost of hospitalization. We also evaluated the effects of a combination of viral testing with serum procalcitonin (PCT) levels on the duration of antibiotic use. Findings: Between October 2017 and July 2018, 761 eligible patients were enrolled (383 in the POCT group and 378 in the control group). The positive rates of virus and atypical pathogens in the POCT group was 31·7% (121/383) compared with 17·2% (32/378) in the control group (difference 14·5%, 95% CI 7·3% to 21·6%; P = 0·0003). The median duration of intravenous antibiotics in the POCT group was significantly shorter than that in the control group (7·0 days [IQR, 5·0, 9·0] in the POCT group vs 8·0 [IQR, 6·0, 11·0] days in the control group; mean difference -1·6 days, 95% CI -2·2 to -1·0 days; P < 0·0001). The median length of hospital stay of patients in the POCT group was significantly shorter than that in the control group (8·0 days [IQR, 6·0, 10·0] in the POCT group vs 9·0 days [IQR, 7·0, 12·0] in the control group; mean difference -1·1 days, 95% CI -1·7 to -0·5 days; P < 0·0001). The median cost of hospitalization was significantly lower in the POCT group ($1,761·1 [IQR, 1,261·1, 2581·3] in the POCT group vs $2,017·3 [IQR, 1,442·9, 2,894·3] in the control group). Furthermore, the median duration of intravenous antibiotic treatment was significantly shorter and the median cost of hospitalization was significantly lower in patients with a positive FilmArray Respiratory Panel test result and PCT < 0·25 ng/mL compared with a negative FilmArray test result and PCT ≥ 0·25 ng/mL (6·0 days [IQR, 4·5, 7·5] vs 7·0 days [IQR, 6·0, 10·5]; mean difference 2·3 days, 95% CI 0·6 to 4·0 days; P = 0·0079 and $1,374·6 [IQR, 1,034·2, 1991·7] vs $1,939·6 [IQR, 1,307·6, 2,955·7]). Interpretation: The use of POCT testing for respiratory viruses and atypical pathogens could help to optimize antibiotic use and improve clinical outcomes in hospitalized LRTI patients. Clinical Trial Number: clinicaltrials.gov Identifier: NCT03391076. Funding Statement: National Science Grant for Distinguished Young Scholars (81425001/H0104) Declaration of Interests: We declare that we have no competing interests. Ethics Approval Statement: The study was approved by the Ethics Committee of CJFH. Written informed consent was obtained from each participant before data collection.