Galle

Researchers are evaluating the effects of the SGLT2 inhibitor dapagliflozin compared to metformin on the annual decline in kidney function, measured by eGFR, in people with Type 2 Diabetes. This Phase 3, randomized, double-blind trial is conducted in primary care and community sites in Australia and tertiary care centers in Sri Lanka. The purpose is to understand which first-line therapy may better prevent kidney decline in this population. After a 4-week active run-in period, participants will be randomly assigned to one of two groups one group will take dapagliflozin 10 mg once daily with placebo metformin tablets, and the other group will take metformin XR 2000 mg once daily with placebo dapagliflozin tablets. Treatment will continue for 2 years under quadruple masking to maintain study integrity. During the study, participants will undergo assessments including kidney function tests eGFR, serum creatinine, urine albumin creatinine ratio, blood sugar measurements HbA1C, fasting glucose, blood pressure monitoring, body weight check, and quality of life evaluations using the EQ-5D-5L. Mental health symptoms such as anxiety and depression will also be measured with the HADS questionnaire. The primary outcome is the rate of eGFR decline over 24 months, with safety and other health indicators monitored throughout the study period.

Researchers are evaluating an electronic clinical decision support tool eCDST designed to help diagnose and treat lower respiratory tract infections LRTI in patients aged 14 years and older at three hospitals in Southern Sri Lanka. This open-label, stepped-wedge, cluster-randomized trial aims to compare clinical outcomes and antibacterial prescribing between patients managed with the eCDST and those receiving usual care. The study will enroll 765 patients and monitor them over 30 days to assess the impact of the tool on treatment decisions and patient health. Participants are grouped by hospital wards that switch from usual care to the eCDST at intervals of 3 to 6 months until all wards use the intervention. Clinicians in the intervention arm use the eCDST on mobile phones to receive diagnostic plans and treatment recommendations, including point-of-care testing conducted by clinical or trained research staff. Usual care participants receive standard diagnostic testing and treatment at clinician discretion. Final decisions on antimicrobial prescriptions remain with the treating doctors. During the study, participants are followed for 30 days after enrollment to record clinical outcomes and antibacterial use, with a maximum antibacterial prescription duration of 14 days. Researchers will monitor various outcomes including adverse events related to withholding antibacterials, duration of antibacterial use, hospital readmissions, ventilator use, ICU admissions, oxygen supplementation, and physician adherence to eCDST recommendations. Assessments include clinical monitoring and routine diagnostic tests according to each treatment arm.