Impact of an electronic clinical decision support tool on duration of antibacterial use and clinical improvement in patients hospitalized with lower respiratory tract infection compared to standard treatment in southern Sri Lanka: A stepped-wedge cluster randomized trial

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1.Admitted within prior 48 hours of admission to the hospital
2.Have evidence of new acute respiratory illness (<14 days of any symptoms), as indicated by at least one of the following:
a.New cough or sputum production (New cough will be the initiation of an acute cough or worsening in frequency and intensity of a chronic cough.)
b.Chest pain
c.Dyspnea or tachypnea (respiratory rate >20 breaths/minute)
d.Abnormal lung examination
3.Have evidence of acute infection, as indicated by at least one of the following:
a.Self-reported fever or chills
b.Documented fever ?38 ?C (100.4 ?F)
c.Documented hypothermia <35.5 ?C (95.9 ?F)
d.Leukocytosis (white blood cell count >10,000/mm3)
e.Leukopenia (white blood cell count <3000/mm3)
f.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

An individual who meets any of the following criteria will be excluded from participation in this study:
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:
a.Vasopressor therapy
b.Cystic fibrosis
c.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);
d.Have an accompanying non-respiratory infection
e.Have evidence of a lung abscess or empyema 7,48
f.Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation