Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06331364
Other study ID # Pro00114347
Secondary ID R01AI168420
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date August 2026

Study information

Verified date May 2024
Source Duke University
Contact Gayani Tillekeratne, MD, MSc
Phone (919) 681-7516
Email gayani.tillekeratne@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka. The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group. The study will enroll 765 patients ≥ 14 years of age. Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 765
Est. completion date August 2026
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: 1. Admitted within prior 48 hours 2. Have evidence of new acute respiratory illness (<14 days of symptoms), as indicated by at least one of the following: 1. New cough or sputum production 2. Chest pain 3. Dyspnea or tachypnea (respiratory rate >20 breaths/minute) 4. Abnormal lung examination 3. Have evidence of acute infection, as indicated by at least one of the following: 1. Self-reported fever or chills 2. Documented fever =38 ° C (100.4 ° F) 3. Documented hypothermia <35.5 ° C (95.9 ° F) 4. Leukocytosis (white blood cell count >10,000/mm3) 5. Leukopenia (white blood cell count <3000/mm3) 6. New altered mental status 4. Ability and willingness of patient, parent or legally authorized representative (LAR) to give informed consent 5. Ability of children 14-17 years of age to provide assent 6. Ability to complete follow-up encounter at 30 days in person or by telephone Exclusion Criteria: 1. Hospitalized recently (within last 28 days) 2. If they have been enrolled into this clinical trial previously 3. Surgery in the past 7 days 4. If they are unable or unwilling to complete the follow-up encounter 5. If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital) 6. If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials: 1. Vasopressor therapy 2. Cystic fibrosis 3. Known severe immunosuppression (i. Cancer or another condition with neutropenia (absolute neutrophil count <1000/ microL; ii. Solid- organ or hematopoietic stem-cell transplant within the previous 90 days; iii. Active graft-versus-host disease or bronchiolitis obliterans; iv. On chronic steroids equivalent to prednisone 20mg daily for = 2 weeks or other targeted cytotoxic or biologic immunosuppressants within the prior 4 weeks; v. Human immunodeficiency virus infection with a CD4 cell count <200/mm3) 4. Have an accompanying non-respiratory infection 5. Have evidence of a lung abscess or empyema 6. Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation

Study Design


Intervention

Other:
electronic clinical decision support tool (eCDST) diagnostic plan
Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials used. Analyses will compare clinical outcomes and antimicrobial use between the intervention arm and usual care.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Duke University National Institute of Allergy and Infectious Diseases (NIAID)

Outcome

Type Measure Description Time frame Safety issue
Primary Total duration of antibacterial prescription for the index visit Total duration of antibacterial prescription for the index visit will include the number of days that antibacterials are prescribed during the index hospitalization, as well as the number of days that antibacterials are prescribed at discharge from the hospital (intended use). Index hospitalization, up to approximately 30 days
Primary Composite of adverse outcomes that could be attributed to withholding antibacterials A binary clinical endpoint consisting of a composite of adverse outcomes that could be attributed to withholding antibacterials. These outcomes would not be present at enrollment, and could occur anytime until Day 30. Day 30
Secondary Proportion of participants using non-invasive ventilation Use of non-invasive ventilation (i.e., continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for treatment of the acute illness ) Day 30
Secondary Proportion of participants using mechanical ventilation Use of mechanical ventilation (via endotracheal tube) Day 30
Secondary Proportion of participants readmitted to the hospital Proportion of participants readmitted to the hospital Day 30
Secondary Proportion of deaths Proportion of deaths Day 30
Secondary Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription Day 30
Secondary Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization Index hospitalization, up to approximately 30 days
Secondary Duration of admission to the intensive care unit (ICU) during index hospitalization Duration of admission to the intensive care unit (ICU) during index hospitalization Index hospitalization, up to approximately 30 days
Secondary Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization Index hospitalization, up to approximately 30 days
Secondary Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization Index hospitalization, up to approximately 30 days
Secondary Duration of non-invasive ventilation during index hospitalization Duration of non-invasive ventilation during index hospitalization Index hospitalization, up to approximately 30 days
Secondary Duration of mechanical ventilation during index hospitalization Duration of mechanical ventilation during index hospitalization Index hospitalization, up to approximately 30 days
Secondary Duration of index hospitalization Duration of index hospitalization Index hospitalization, up to approximately 30 days
Secondary Proportion prescribed antibacterials- cumulative Any prescription of antibacterials from enrollment to the point of assessment will be considered prescription of antibacterials. Day 1, Day 2, Day 3, by discharge, and by Day 30
Secondary Proportion prescribed antibacterials- at time of assessment Prescription of antibacterials will only be assessed at the specific time of assessment Day 1, Day 2, Day 3, by discharge, and by Day 30
Secondary Total antibacterial exposure per patient during hospitalization This is defined as the total number of days prescribed an antibacterial Day 30
Secondary Proportion prescribed oseltamivir- cumulative Any prescription of oseltamivir from enrollment to the point of assessment will be considered prescription of oseltamivir Day 1, Day 2, Day 3, at discharge, and by Day 30
Secondary Proportion prescribed oseltamivir- at time of assessment Prescription of oseltamivir will only be assessed at the specific time of assessment Day 1, Day 2, Day 3, at discharge, and by Day 30
Secondary Total oseltamivir exposure per patient during hospitalization This is defined as the total number of days prescribed oseltamivir Day 30
Secondary Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative Any prescription of SARS-CoV-2 antivirals from enrollment to the point of assessment will be considered prescription of SARS-CoV-2 antivirals Day 1, Day 2, Day 3, at discharge, and by Day 30
Secondary Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment Prescription of SARS-CoV-2 antivirals will only be assessed at the specific time of assessment Day 1, Day 2, Day 3, at discharge, and by Day 30
Secondary Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed Physician adherence to the eCDST diagnostic recommendations within 24 hours of receiving recommendations, in the intervention group. 24 hours
Secondary Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed Physician adherence to the eCDST diagnostic recommendations within 48 hours of receiving recommendations, in the intervention group. 48 hours
Secondary Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed 24 hours and 48 hours
Secondary Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed 24 hours and 48 hours
Secondary Physician adherence, as measured by the proportion in whom all treatment recommendations were followed Physician adherence, as measured by the proportion in whom all treatment recommendations were followed 24 hours and 48 hours
See also
  Status Clinical Trial Phase
Completed NCT03191071 - An Algorithm to Decide on Antibiotic Prescription in Lower Respiratory Tract Infection in Primary Care N/A
Not yet recruiting NCT05534555 - Point of Care Testing Using FebriDx in Primary Care: a Mixed Methods Feasibility Study N/A
Completed NCT03361670 - Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel N/A
Recruiting NCT05423847 - Triage UltraSound in Tb Endemic Regions
Completed NCT04239521 - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Terminated NCT04225897 - A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection. Phase 2
Recruiting NCT04829188 - Comparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia N/A
Active, not recruiting NCT03460171 - Clinical Features, Outcome and Prognosis of Human Metapneumovirus (hMPV) Lower Respiratory Tract Infections in Adult Inpatients
Withdrawn NCT04267822 - Study of RV521 in the Treatment of Adult Subjects Who Have Undergone HCT With an URTI With RSV Phase 2
Completed NCT02979626 - Evaluation of Moderate to Severe Influenza Outcomes in Children
Completed NCT04602234 - Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice N/A
Completed NCT03379779 - Evaluation the Association of Microbiome Between Respiratory Tract Samples and Stool Samples in Pneumonic Patients Accompanied by Respiratory Failure
Completed NCT04320862 - COVID-19 Pandemic Response Network