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

NCT ID: NCT06331364

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 765 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-01-31

Brief 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 (a maximum of 14 days).

Conditions

Lower Resp Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Clinicians will be asked to use the diagnostic portion of the electronic clinical decision tool (eCDST) on their mobile phones, into which they will enter inputs and receive a diagnostic plan. Point of care (POC) testing as advised by the eCDST will be conducted by either clinical staff or trained research staff. If performed by research staff, results will be delivered on paper within 6 hours of testing to ≥ 2 primary clinicians on the team (including the consultant/ attending-level physician or senior registrar). THK, DGM, and DGH do not have an electronic medical record system. Clinicians will be asked to input the results from diagnostic testing and to follow the treatment recommendations as per the eCDST, but will be advised that the final decision regarding prescription of antimicrobials is entirely at their discretion.

Group Type: EXPERIMENTAL

electronic clinical decision support tool (eCDST) diagnostic plan

Intervention Type: OTHER

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.

Usual Care Arm

Study staff will inform the treating clinicians to diagnose and treat patients according to usual practice. Clinicians will be able to order routine diagnostic testing as per standard practice.

These tests may include complete blood count, chemistries, C-reactive protein (CRP) testing, erythrocyte sedimentation rate (ESR) testing, blood and sputum cultures, and chest x-ray or chest CT imaging.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gayani Tillekeratne, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Duke University

Central Contacts

Gayani Tillekeratne, MD, MSc

Role: CONTACT

gayani.tillekeratne@duke.edu

(919) 681-7516

Stefany Olague, MPH

Role: CONTACT

stefany.olague@duke.edu

(919)668-8131

Other Identifiers

R01AI168420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00114347

Identifier Type: -

Identifier Source: org_study_id