[{"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":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100631662","phase-3-the-effect-of-adjunctive-melatonin-with-colistin-in-patients-with-multidrug-resistant-gram-negative-bacterial-infections-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":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Multidrug-Resistant Gram-Negative Bacterial Infections","Antimicrobial Resistance",[29,30,31,32],"Gram-Negative Infections","multidrug resistance","colistin","gram negative infections","NOT_YET_RECRUITING","2026-03-26",{"date":36,"type":37},"2026-03-31","ACTUAL",{"date":34,"type":20},{"date":40,"type":20},"2026-08-26",{"name":42,"class":43},"Ain Shams University","OTHER","Multidrug Resistant Gram Negative Bacterial Infections"]