Lower Resp Tract InfectionTREAT-SLNCT06331364
TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial
A study testing electronic clinical decision support tool (eCDST) diagnostic plan in people with Lower Resp Tract Infection, run by Duke University at 3 sites in Sri Lanka.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Lower Resp Tract Infection
- What is being tested?
- electronic clinical decision support tool (eCDST) diagnostic plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 765 participants
- Where
- 3 sitesSri Lanka
- Study dates
- 27 Feb 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
- Ability to complete follow-up encounter at 30 days in person or by telephone
Who cannot join
- 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:
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sri Lanka3 sites, 3 recruiting
- Recruiting
Base Hospital Balapitiya
Balapitiya
Warsha De Zoysa, MBBS, +94912234801 ext. 429, duke.ruhuna@gmail.com
- Recruiting
Galle National Hospital
Karapitiya
Warsha De Zoysa, MBBS, +94912234801 ext. 429, duke.ruhuna@gmail.com
Warsha De Zoysa, MBBS
- Recruiting
District General Hospital Matara
Matara
Warsha De Zoysa, MBBS, +94912234801 ext. 429, duke.ruhuna@gmail.com
Warsha De Zoysa, MBBS
About this study
Official title: TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): A Stepped-wedge Cluster Randomized Trial of an Electronic Clinical Decision Support Tool (eCDST) for the Diagnosis and Treatment of Lower Respiratory Tract Infection (LRTI) in Selected Hospitals in Southern Sri Lanka
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
- Being tested
- electronic clinical decision support tool (eCDST) diagnostic plan
- Keywords
- eCDST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic clinical decision support tool (eCDST) diagnostic planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Index hospitalization, up to approximately 14 days
Secondary outcomes (25)
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 )
Measured: Day 30
Proportion of participants using mechanical ventilation
Use of mechanical ventilation (via endotracheal tube)
Measured: Day 30
Proportion of participants readmitted to the hospital
Proportion of participants readmitted to the hospital
Measured: Day 30
Proportion of deaths
Proportion of deaths
Measured: Day 30
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
Measured: Day 30
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
Measured: Index hospitalization, up to approximately 30 days
Duration of admission to the intensive care unit (ICU) during index hospitalization
Duration of admission to the intensive care unit (ICU) during index hospitalization
Measured: Index hospitalization, up to approximately 30 days
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
Measured: Index hospitalization, up to approximately 30 days
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
Measured: Index hospitalization, up to approximately 30 days
Duration of non-invasive ventilation during index hospitalization
Duration of non-invasive ventilation during index hospitalization
Measured: Index hospitalization, up to approximately 30 days
Duration of mechanical ventilation during index hospitalization
Duration of mechanical ventilation during index hospitalization
Measured: Index hospitalization, up to approximately 30 days
Duration of index hospitalization
Duration of index hospitalization
Measured: Index hospitalization, up to approximately 30 days
Proportion prescribed antibacterials- cumulative
Any prescription of antibacterials from enrollment to the point of assessment will be considered prescription of antibacterials.
Measured: Day 1, Day 2, Day 3, by discharge, and by Day 30
Proportion prescribed antibacterials- at time of assessment
Prescription of antibacterials will only be assessed at the specific time of assessment
Measured: Day 1, Day 2, Day 3, by discharge, and by Day 30
Total antibacterial exposure per patient during hospitalization
This is defined as the total number of days prescribed an antibacterial
Measured: Day 30
Proportion prescribed oseltamivir- cumulative
Any prescription of oseltamivir from enrollment to the point of assessment will be considered prescription of oseltamivir
Measured: Day 1, Day 2, Day 3, at discharge, and by Day 30
Proportion prescribed oseltamivir- at time of assessment
Prescription of oseltamivir will only be assessed at the specific time of assessment
Measured: Day 1, Day 2, Day 3, at discharge, and by Day 30
Total oseltamivir exposure per patient during hospitalization
This is defined as the total number of days prescribed oseltamivir
Measured: Day 30
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
Measured: Day 1, Day 2, Day 3, at discharge, and by Day 30
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
Measured: Day 1, Day 2, Day 3, at discharge, and by Day 30
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.
Measured: 24 hours
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.
Measured: 48 hours
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
Measured: 24 hours and 48 hours
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
Measured: 24 hours and 48 hours
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
Measured: 24 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start27 Feb 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Resp Tract InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 765 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gayani Tillekeratne, MD, MSc, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331364
- Sponsor's protocol ID
- Pro00114347
- Other IDs
- R01AI168420
- Acronym
- TREAT-SL
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;27(1):324. doi: 10.1186/s13063-026-09628-0.
PubMed 41851897