[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631662":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":25,"responsibleParty":34,"collaborators":25,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":25,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":25,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":62,"whyStopped":25,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":25},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"melatonin","EXPERIMENTAL","Patients will receive oral melatonin 60 mg once daily, initiated concurrently with the administration of the colistin loading dose",[13],"Drug: Melatonin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients will receive matching placebo capsules following the same dosing schedule.",[19],"Other: Placebo",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Melatonin",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Aalaa Kamal Shata, MD","CONTACT","+201129214940","aalaashata@yahoo.com",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Eman Mohamed El Mokadem","Lecturer of Pharmacy Practice and Clinical Pharmacy","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":48,"type":49},70,"ESTIMATED","INTERVENTIONAL",[52],"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.",[55,56],"Multidrug-Resistant Gram-Negative Bacterial Infections","Antimicrobial Resistance",[58,59,60,61],"Gram-Negative Infections","multidrug resistance","colistin","gram negative infections","NOT_YET_RECRUITING","2026-03-26",{"date":65,"type":66},"2026-03-31","ACTUAL",{"date":63,"type":49},{"date":69,"type":49},"2026-08-26",{"name":5,"class":6}]