Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen
Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2026-04-30
Target enrollment:
Participant gender:
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