[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570107":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":10,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":10,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":10,"studyType":45,"phases":10,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":10},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria",null,[12,13],"Drug: Tigecycline (Tygacil)","Drug: Colistimethate sodium (CMS)",[15,20],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Tigecycline (Tygacil)","tigecycline-based regimen administered both intravenously (IV) and intraventricularly (IVT) for 14-21 days",[9],{"type":16,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Colistimethate sodium (CMS)","Colistimethate sodium-based regimen (standard therapy for MDR infections) administered both IV and IVT for 14-21 days.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Abdelwahab, MSc","CONTACT","+20-1224959630","Nouran_elsherazy@yahoo.com",{"type":31,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100570107","comparing-tigecycline-vs-colistimethate-in-cns-infections-100570107",false,"NCT06702943","Comparing Tigecycline Vs. Colistimethate in CNS Infections","Comparative Study of the Efficacy and Safety of Tigecycline Based Regimen Versus Colistimethate Sodium-based Regimen in Patients with Central Nervous System Bacterial Infections","Inclusion Criteria:\n\n* Pediatric patients aged 1 month to 18 years.\n* Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.\n* EVD placement for managing CNS infections.\n\nExclusion Criteria:\n\n* Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.\n\nNeonates (less than 1 month old).","ALL","28 Days","18 Years",{"count":43,"type":44},70,"ESTIMATED","OBSERVATIONAL","This observational study compares the efficacy and safety of tigecycline, an alternative antibiotic with broad-spectrum activity, versus the standard colistimethate sodium-based regimen in managing these infections in pediatric patients.\n\nInclusion Criteria:\n\nPediatric patients aged 1 month to 18 years. Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings.\n\nEVD placement for managing CNS infections.\n\nExclusion Criteria:\n\nKnown allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.\n\nNeonates (less than 1 month old), pregnant, or breastfeeding patients.\n\nOutcome Measures:\n\nPrimary Outcomes: Clinical cure (resolution of infection symptoms) and microbiological cure (sterilization of CSF cultures).\n\nSecondary Outcomes: Mortality rates and adverse drug events, such as nephrotoxicity, hepatotoxicity, chemical meningitis, or seizures.",[48],"Central Nervous System Infections",[50,51],"Central nervous system infections","MDR bacteria","NOT_YET_RECRUITING","2024-11-22",{"date":55,"type":56},"2024-11-25","ACTUAL",{"date":58,"type":44},"2024-12-01",{"date":60,"type":44},"2027-06",{"name":5,"class":6}]