[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multidrug-resistant-gram-negative-bacterial-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multidrug-resistant-gram-negative-bacterial-infections":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100631662",false,"NCT07503600","The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections","Inclusion Criteria:\n\n* • Confirmed diagnosis of infection caused by multidrug-resistant Gram-negative bacteria based on microbiological culture and sensitivity testing\n\n  * Patients receiving intravenous colistin therapy according to institutional protocols\n  * Clinical diagnosis of sepsis or severe infection in accordance with established critical care criteria\n\nExclusion Criteria:\n\n* • Pregnancy or lactation\n\n  * Terminal medical or surgical illness (e.g., advanced malignancy)\n  * Severe chronic liver disease or end-stage renal failure\n  * Impaired cognitive function or active psychiatric illness under treatment\n  * Known hypersensitivity to melatonin\n  * Use of melatonin within 48 hours prior to enrollment","ALL","18 Years","70 Years",{"count":18,"type":19},70,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This study evaluates whether adding melatonin to standard colistin therapy improves outcomes in patients with multidrug-resistant (MDR) Gram-negative bacterial infections. These infections are difficult to treat and are associated with high morbidity and mortality, particularly in critically ill patients.\n\nColistin is often used as a last-line antibiotic for these infections; however, its effectiveness may be limited, and it is associated with side effects such as kidney injury. Melatonin, a naturally occurring hormone, has antioxidant, anti-inflammatory, and immune-modulating properties that may enhance the effectiveness of antibiotics and reduce treatment-related complications.\n\nIn this randomized, double-blind, placebo-controlled study, adult patients receiving colistin will be assigned to receive either melatonin or a placebo in addition to standard care. The study will assess whether melatonin improves oxidative stress, infection control, and clinical outcomes while maintaining safety.",[25,26],"Multidrug-Resistant Gram-Negative Bacterial Infections","Antimicrobial Resistance",[28,29,30,31],"Gram-Negative Infections","multidrug resistance","colistin","gram negative infections","NOT_YET_RECRUITING","2026-03-26",{"date":35,"type":36},"2026-03-31","ACTUAL",{"date":33,"type":19},{"date":39,"type":19},"2026-08-26",{"name":41,"class":42},"Ain Shams University","OTHER",""]