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

NCT06331364 | Recruiting DMC

• 2 other identifiers: Pro00114347R01AI168420
• Study Type: interventional
• Target: 765
• Locations: 1 country
• Sites: 3

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

Keywords

eCDST

Outcome Measures

Primary Outcomes (2)

• 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

• 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 14 days

Secondary Outcomes (25)

• Proportion of participants using non-invasive ventilation

  Day 30

• Proportion of participants using mechanical ventilation

  Day 30

• Proportion of participants readmitted to the hospital

  Day 30

• Proportion of deaths

  Day 30

• Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription

  Day 30

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Other: electronic clinical decision support tool (eCDST) diagnostic plan

Usual Care Arm

NO INTERVENTION

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.

Interventions

electronic clinical decision support tool (eCDST) diagnostic plan 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.

Intervention Arm

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted within prior 48 hours
• Have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following:
• New cough or sputum production
• Chest pain
• Dyspnea or tachypnea (respiratory rate \>20 breaths/minute)
• Abnormal lung examination
• Have evidence of acute infection, as indicated by at least one of the following:
• Self-reported fever or chills
• Documented fever ≥38 ̊ C (100.4 ̊ F)
• Documented hypothermia \<35.5 ̊ C (95.9 ̊ F)
• Leukocytosis (white blood cell count \>10,000/mm3)
• Leukopenia (white blood cell count \<3000/mm3)
• New altered mental status
• Ability and willingness of patient, parent or legally authorized representative (LAR) to give informed consent
• Ability of children 14-17 years of age to provide assent

You may not qualify if:

• 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
• If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital)
• If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials:
• Vasopressor therapy
• Cystic fibrosis
• 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)
• Have an accompanying non-respiratory infection
• Have evidence of a lung abscess or empyema
• Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

Base Hospital Balapitiya

Balapitiya, Sri Lanka

RECRUITING

Galle National Hospital

Karapitiya, Sri Lanka

RECRUITING

District General Hospital Matara

Matara, Sri Lanka

RECRUITING

Related Publications (1)

• De Zoysa PDWD, Weerasinghe SA, Gamage J, Iglesias-Ussel MD, Olague S, Obale A, Gallis JA, Palangasinghe D, Senadheera B, Vasana S, Nix C, Bodinayake CK, Nagahawatte ADS, Wijayaratne WMDGB, Kurukulasooriya MRP, Premamali M, Dilshan UHBY, Ngocho J, Ostbye T, Laber EB, Watt MH, Myers E, Woods CW, Naggie S, Kenny A, Chakraborty H, Tillekeratne LG. TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): study protocol for a stepped-wedge, cluster-randomized clinical trial. Trials. 2026 Mar 18. doi: 10.1186/s13063-026-09628-0. Online ahead of print.

  PMID: 41851897 DERIVED

Study Officials

• Gayani Tillekeratne, MD, MSc

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gayani Tillekeratne, MD, MSc

CONTACT

(919) 681-7760; gayani.tillekeratne@duke.edu

Stefany Olague, MPH

CONTACT

(919)668-8131; stefany.olague@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge, cluster randomized, two-arm, open label This design combines elements of a cluster randomized trial (intervention is applied in clusters) and a before-after design (each cluster switches to intervention). All 9 pairs of wards (clusters) will start with an initial period of usual care. At intervals of 3-6 months (steps), a set of 3 pairs of wards (clusters) will switch in a randomized order to use the intervention, until all pairs of wards have crossed over. We will use the stepped-wedge design since 1) this design may provide higher statistical power, since clusters act as their own controls, 2) to reduce contamination bias, and 3) to reduce the risk of a cluster dropping out of the study if assigned to the control group.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 26, 2024
• Study Start: February 27, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SR (3)