NCT07258225

Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen

Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen in Critically Ill Patients

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Air Force Specialized Hospital, Cairo, Egypt · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multi Drug Resistant Infections

Interventions

Type	Name	Description
DRUG	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.
DRUG	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

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-02-01
• Completion: 2026-04-30
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: Egypt