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Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen
Sponsor: Air Force Specialized Hospital, Cairo, Egypt
Summary
To compare the clinical response (efficacy) and the safety of the tigecycline once daily regimen versus the standard regimen (twice daily regimen). Clinical response was categorized as a cure, failure of treatment, or indeterminate outcome.24 Treatment success (Cure): defined as resolution of signs/symptoms of infection, microbiological cure (negative cultures after tigecycline use), improvement of infection markers (leukocytic count, C reactive protein, and procalcitonin). Treatment failure: defined as persistence of signs/symptoms of infection despite antimicrobial therapy, deterioration of infection markers (leukocytic count, C reactive protein, and Procalcitonin). Indeterminate response: subjects who do not have an outcome determination for reasons unrelated to the study drug or infection (e.g., loss to follow-up, withdrawal of consent, etc.) Safety will be assessed by the incidence of adverse events especially which leads to treatment discontinuation.36
Official title: Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen in Critically Ill Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2024-04-01
Completion Date
2026-04-30
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
Tigecycline once daily regimen
Tigecycline once-daily regimen (100 mg once daily) or (200 mg once daily). For hepatic patients with a Child-Pugh score (C), the loading dose is 100 mg, then 50 mg every 24 hours.
Usual doses of tigecycline
Tigecycline standard dose (100 mg loading dose then 50 mg every 12 hours) or (200 mg loading dose then 100 mg every 12 hours). For hepatic patients with Child-Pugh score (C), the loading dose is 100 mg then 25 mg every 12 hours
Locations (1)
Air force specialized hospital
Cairo, Cairo Governorate, Egypt