Bangkok Noi, Thailand
A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
Phase
2Span
312 weeksSponsor
GlaxoSmithKlineBangkok
Recruiting
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations. Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.
Phase
3Span
238 weeksSponsor
Daiichi SankyoBangkok
Recruiting
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
Phase
3Span
258 weeksSponsor
Bristol-Myers SquibbBangkok, Krung Thep Maha Nakhon
Recruiting
Bangkok
Recruiting
Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity
Phase
N/ASpan
160 weeksSponsor
Mahidol UniversityBangkok
Recruiting
Efficacy of Combination Therapy With Minocycline for Treatment of Stenotrophomonas Maltophilia Infections
- Investigator inform patient or their relatives about all topics in project, eligible criteria, method, material and monitoring treatment. - After patient or their relatives are appreciated to join this project, patients will be randomly allocated to either levofloxacin or cotrimoxazole plus placebo (monotherapy plus placebo) or levofloxacin or cotrimoxazole plus minocycline (combination therapy). - Duration of treatment is determined by site and severity of infection, approximately 7-28 days. - Sample size calculation, by two independent proportions formula, the investigators estimate the mortality rate about 54 % in monotherapy group and mortality rate about 27 % in combination therapy with minocycline group, with 2-sided 95% Confidence interval; therefore,51 persons are needed each group. - The investigators estimate gather data about 112 persons. (56 participants with monotherapy and 56 participants with combination therapy (minocycline plus another antibiotic drug from intervention trial)) - The categorical variables are reported as frequencies and percentages, while continuous variables are reported as means ± standard deviations for normally distributed data and median ± range for non-normally distributed data. The data collected from patients are compared using Chi-square tests or Fisher's exact tests for categorical variables and using t-tests or Mann-Whitney U-tests for continuous variables. - During the study is performing, all unexpected adverse event definitely report to Siriraj institutional Review Board immediately, in addition to subjects or their relatives.
Phase
4Span
102 weeksSponsor
Mahidol UniversityBangkok
Recruiting
Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Carbapenem-Resistant A. Baumannii Infection
The purpose of this double-blind, randomized, parallel, placebo-controlled clinical trial is to assess whether the association of colistin and minocycline reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone. The trial will enroll 94 patients from internal medicine ward and intensive care units (ICU) of an university care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin plus placebo (control arm) or colistin plus minocycline (experimental arm). Primary end point is overall mortality, defined as death occurring within 28 days from randomisation.
Phase
4Span
77 weeksSponsor
Mahidol UniversityBangkok
Recruiting
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Phase
3Span
209 weeksSponsor
Hoffmann-La RocheBangkok
Recruiting
Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
The investigators will randomize patients colonized by CRE (diagnosed by rectal swab) to Neomycin by stratified randomization according to type of CRE species (E.coli or non-E.coli). Then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and will be collected, up to 14 days after Neomycin.
Phase
4Span
71 weeksSponsor
Mahidol UniversityBangkok
Recruiting