TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorDuke University

About this trial

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 (a maximum of 14 days).

Eligibility criteria

Qualifiers

Admitted within prior 48 hours

New cough or sputum production

Chest pain

Dyspnea or tachypnea (respiratory rate >20 breaths/minute)

Disqualifiers

Hospitalized recently (within last 28 days)

If they have been enrolled into this clinical trial previously

Surgery in the past 7 days

If they are unable or unwilling to complete the follow-up encounter

Trial design

Treatments tested in this trial

  • electronic clinical decision support tool (eCDST) diagnostic plan

Treatment groups

765 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator