Browsing by Author "Charuluxananan S."

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    Early treatment with fluvoxamine, bromhexine, cyproheptadine, and niclosamide to prevent clinical deterioration in patients with symptomatic COVID-19: a randomized clinical trial
    (2024-04-01) Wannigama D.L.; Hurst C.; Phattharapornjaroen P.; Hongsing P.; Sirichumroonwit N.; Chanpiwat K.; Ali A.H.; Storer R.J.; Ounjai P.; Kanthawee P.; Ngamwongsatit N.; Kupwiwat R.; Kupwiwat C.; Brimson J.M.; Devanga Ragupathi N.K.; Charuluxananan S.; Leelahavanichkul A.; Kanjanabuch T.; Higgins P.G.; Badavath V.N.; Amarasiri M.; Verhasselt V.; Kicic A.; Chatsuwan T.; Pirzada K.; Jalali F.; Reiersen A.M.; Abe S.; Ishikawa H.; Tanasatitchai C.; Amphol S.; Nantawong L.; Sangchan P.; Sinkajarern V.; Phoonakh T.; Utenpattanun P.; Sithu Shein A.M.; Vitoonpong T.; Chongthavonsatit N.; Mankong Y.; Chaichana P.; Yaithet J.; Pongprajak D.; Traimuangpak S.; Saksirisampant G.; Lamloeskittinon P.; Hamdy A.A.; Kosasih S.S.; Luk-in S.S.; Wannigama D.L.; Mahidol University
    Background: Repurposed drugs with host-directed antiviral and immunomodulatory properties have shown promise in the treatment of COVID-19, but few trials have studied combinations of these agents. The aim of this trial was to assess the effectiveness of affordable, widely available, repurposed drugs used in combination for treatment of COVID-19, which may be particularly relevant to low-resource countries. Methods: We conducted an open-label, randomized, outpatient, controlled trial in Thailand from October 1, 2021, to June 21, 2022, to assess whether early treatment within 48-h of symptoms onset with combinations of fluvoxamine, bromhexine, cyproheptadine, and niclosamide, given to adults with confirmed mild SARS-CoV-2 infection, can prevent 28-day clinical deterioration compared to standard care. Participants were randomly assigned to receive treatment with fluvoxamine alone, fluvoxamine + bromhexine, fluvoxamine + cyproheptadine, niclosamide + bromhexine, or standard care. The primary outcome measured was clinical deterioration within 9, 14, or 28 days using a 6-point ordinal scale. This trial is registered with ClinicalTrials.gov (NCT05087381). Findings: Among 1900 recruited, a total of 995 participants completed the trial. No participants had clinical deterioration by day 9, 14, or 28 days among those treated with fluvoxamine plus bromhexine (0%), fluvoxamine plus cyproheptadine (0%), or niclosamide plus bromhexine (0%). Nine participants (5.6%) in the fluvoxamine arm had clinical deterioration by day 28, requiring low-flow oxygen. In contrast, most standard care arm participants had clinical deterioration by 9, 14, and 28 days. By day 9, 32.7% (110) of patients in the standard care arm had been hospitalized without requiring supplemental oxygen but needing ongoing medical care. By day 28, this percentage increased to 37.5% (21). Additionally, 20.8% (70) of patients in the standard care arm required low-flow oxygen by day 9, and 12.5% (16) needed non-invasive or mechanical ventilation by day 28. All treated groups significantly differed from the standard care group by days 9, 14, and 28 (p < 0.0001). Also, by day 28, the three 2-drug treatments were significantly better than the fluvoxamine arm (p < 0.0001). No deaths occurred in any study group. Compared to standard care, participants treated with the combination agents had significantly decreased viral loads as early as day 3 of treatment (p < 0.0001), decreased levels of serum cytokines interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1 beta (IL-1β) as early as day 5 of treatment, and interleukin-8 (IL-8) by day 7 of treatment (p < 0.0001) and lower incidence of post-acute sequelae of COVID-19 (PASC) symptoms (p < 0.0001). 23 serious adverse events occurred in the standard care arm, while only 1 serious adverse event was reported in the fluvoxamine arm, and zero serious adverse events occurred in the other arms. Interpretation: Early treatment with these combinations among outpatients diagnosed with COVID-19 was associated with lower likelihood of clinical deterioration, and with significant and rapid reduction in the viral load and serum cytokines, and with lower burden of PASC symptoms. When started very soon after symptom onset, these repurposed drugs have high potential to prevent clinical deterioration and death in vaccinated and unvaccinated COVID-19 patients. Funding: Ped Thai Su Phai (Thai Ducks Fighting Danger) social giver group.
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    Perioperative Death within 24 Hours: An Analysis of 2,000 Incident Reports of the Perioperative and Anesthetic Adverse Events in Thailand (PAAd Thai) Study
    (2023-09-01) Indrambarya T.; Pongraweewan O.; Prapongsena P.; Ittichaikulthol W.; Charuluxananan S.; Pipanmekaporn T.; Lawthaweesawat C.; Chernsirikasem N.; Ratanasuwan P.; Chanchayanon T.; Sintavanuruk K.; Mahidol University
    Background: Perioperative death is one of the indicators of anesthetic patient safety. The perioperative death rate has dramatically declined with the modern anesthetic techniques and perioperative medicine. Objective: To study contributing factors, factors minimizing incidents, and suggested corrective strategies. Materials and Methods: The present study was part of the Perioperative and Anesthetic Adverse Events in Thailand (PAAd Thai) Study, focusing on the incidents of perioperative death within 24 hours. The perioperative incidents from 22 tertiary hospitals across Thailand were gathered monthly. Two senior anesthesiologists reviewed the reports. Any discrepancy was solved by discussion for a consensus. Results: Of the first 2,000 incident reports in the PAAd Thai Study, there were 404 (20.2%) incident reports of 24 hours perioperative death. Extreme age of less than one year in 6.2% and more than 80 years in 8.2%, with ASA physical status of 3 or more in 97% while 51.2% occurred in the age group between 20 to 64 years. General anesthesia was the main anesthetic technique among fatal cases in 94.1% of the cases. Ninety-one cases (22.5%) occurred in the operating theatre with anesthesiology team witness. The high-risk surgeries with fatal outcomes were general surgery in 46.2%, cardiac surgery in 12.5%, neurological surgery in 11.6%, and endoscopic procedure in 3.2%. Exsanguination in 52.7%, particularly after traffic accident was the major cause of death followed by cardiac factors in 27.2%, and sepsis in 23%. Intraoperative death had higher proportion of exsanguination at 72.5% than postoperative death at 43% (p<0.001). Postoperative death had higher proportion of sepsis-related death and brain death than intraoperative death at 27.5% versus 7.7% (p<0.001), and 20.8% versus 5.5% (p=0.001), respectively. The factor-related death included Patient in 97.8%, Surgical in 42.3%, Anesthetic in 19.3%, and Systematic factors in 31.4%. Fatal causes were considered as preventable in 28.7%, particularly by surgical safety checklist in 18.1%. Conclusion: The multicenter study revealed a high proportion of 24 hours. perioperative death was commonly caused by exsanguination. Postoperative death was related to patient condition. Suggested corrective strategies were quality assurance activity, improved supervision, additional training, ICU availability, and more guidelines and compliance to guidelines including surgical safety checklists.
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    tesG expression as a potential clinical biomarker for chronic Pseudomonas aeruginosa pulmonary biofilm infections
    (2025-12-01) Wannigama D.L.; Hurst C.; Monk P.N.; Hartel G.; Ditcham W.G.F.; Hongsing P.; Phattharapornjaroen P.; Ounjai P.; Torvorapanit P.; Jutivorakool K.; Luk-in S.; Nilgate S.; Rirerm U.; Tanasatitchai C.; Miyanaga K.; Cui L.; Ragupathi N.K.D.; Rad S.M.A.H.; Khatib A.; Storer R.J.; Ishikawa H.; Amarasiri M.; Charuluxananan S.; Leelahavanichkul A.; Kanjanabuch T.; Higgins P.G.; Davies J.C.; Stick S.M.; Kicic A.; Chatsuwan T.; Shibuya K.; Abe S.; Wannigama D.L.; Mahidol University
    Background: Pseudomonas aeruginosa infections in the lungs affect millions of children and adults worldwide. To our knowledge, no clinically validated prognostic biomarkers for chronic pulmonary P. aeruginosa infections exist. Therefore, this study aims to identify potential prognostic markers for chronic P. aeruginosa biofilm lung infections. Methods: Here, we screened the expression of 11 P. aeruginosa regulatory genes (tesG, algD, lasR, lasA, lasB, pelB, phzF, rhlA, rsmY, rsmZ, and sagS) to identify associations between clinical status and chronic biofilm infection. Results: RNA was extracted from 210 sputum samples from patients (n = 70) with chronic P. aeruginosa lung infections (mean age; 29.3–56.2 years; 33 female). Strong biofilm formation was correlated with prolonged hospital stays (212.2 days vs. 44.4 days) and increased mortality (46.2% (18)). Strong biofilm formation is associated with increased tesG expression (P = 0.001), influencing extended intensive care unit (P = 0.002) or hospitalisation stays (P = 0.001), pneumonia risk (P = 0.006), and mortality (P = 0.001). Notably, tesG expression is linked to the modulation of systemic and sputum inflammatory responses and predicts biofilm biomass. Conclusions: This study provides the first clinical dataset of tesG expression levels as a predictive biomarker for chronic P. aeruginosa pulmonary infections.