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

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

Overview

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).

Interventions

• Other 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.

Primary outcome measures

• Composite of adverse outcomes that could be attributed to withholding antibacterials [Time frame: Day 30]
• Total duration of antibacterial prescription for the index visit [Time frame: Index hospitalization, up to approximately 14 days]

Secondary outcome measures (12)

• Proportion of participants using non-invasive ventilation [Time frame: Day 30]
• Proportion of participants using mechanical ventilation [Time frame: Day 30]
• Proportion of participants readmitted to the hospital [Time frame: Day 30]
• Proportion of deaths [Time frame: Day 30]
• Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription [Time frame: Day 30]
• Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization [Time frame: Index hospitalization, up to approximately 30 days]
• Duration of admission to the intensive care unit (ICU) during index hospitalization [Time frame: Index hospitalization, up to approximately 30 days]
• Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization [Time frame: Index hospitalization, up to approximately 30 days]
• Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization [Time frame: Index hospitalization, up to approximately 30 days]
• Duration of non-invasive ventilation during index hospitalization [Time frame: Index hospitalization, up to approximately 30 days]
• Duration of mechanical ventilation during index hospitalization [Time frame: Index hospitalization, up to approximately 30 days]
• Duration of index hospitalization [Time frame: Index hospitalization, up to approximately 30 days]

Eligibility criteria

Inclusion criteria

• 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
• Ability to complete follow-up encounter at 30 days in person or by telephone

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Sri Lanka · 3 centers

• Base Hospital Balapitiya — Balapitiya
• Galle National Hospital — Karapitiya
• District General Hospital Matara — Matara

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 Sele PMID 41851897

Identifiers

NCT: NCT06331364 · Pro00114347 · R01AI168420

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗