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ACTIVE NOT RECRUITING
NCT07258225
PHASE4

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

Sponsor: Air Force Specialized Hospital, Cairo, Egypt

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Air force specialized hospital

Cairo, Cairo Governorate, Egypt