Sungai Petani

Researchers are evaluating an early switch from intravenous (IV) to oral antibiotic treatment for patients with uncomplicated Staphylococcus aureus bloodstream infection (bacteraemia). This phase 3, multicenter, randomized, open-label trial compares the safety and effectiveness of early oral antibiotic therapy against the standard minimum 14-day course of IV antibiotics in patients considered low-risk for complications. The study involves 290 patients from 12 Malaysian tertiary hospitals who have received 3 to 7 days of IV antibiotics. Participants are randomly assigned to either continue standard IV antibiotic treatment or switch early to oral antibiotics, including options like trimethoprim-sulfamethoxazole, clindamycin, cephalexin, or linezolid. The choice of antibiotic depends on bacterial susceptibility and patient factors. The treatment phase lasts 7 to 11 days, followed by a 90-day follow-up period with scheduled phone or inpatient visits. During the approximately 12-week study, patients undergo screening and enrollment, receive open-label antibiotic treatment, and are monitored at days 7-11, 30, and 90 after randomization. Researchers assess outcomes such as the rate of relapse of Staphylococcus aureus bacteraemia within 90 days. Patient condition reviews and standard clinical assessments are conducted to ensure safety and measure treatment effectiveness.

Researchers are evaluating the safety and effectiveness of palazestrant (OP-1250) compared to standard treatments fulvestrant or an aromatase inhibitor in adults with ER-positive, HER2-negative advanced or metastatic breast cancer. Participants have previously received endocrine therapy combined with a CDK4/6 inhibitor, and their cancer has progressed despite this treatment. This phase 3, international, randomized, open-label trial aims to provide new information on treatment options for this population. Participants will be assigned to receive either palazestrant daily in a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or standard endocrine therapy with fulvestrant or one of three aromatase inhibitors (anastrozole, letrozole, or exemestane), given according to their approved schedules. After selecting the optimal palazestrant dose, more participants will be randomized to receive either that dose or standard care. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for adverse events, dose reductions, or treatment discontinuation for up to 16 weeks after randomization. The main outcome is progression-free survival, measured until disease progression or death, with an estimated follow-up of up to 2 years. Assessments will include physical exams, lab tests, and regular evaluations of cancer status and side effects to ensure safety and track the effectiveness of the treatments.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.