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

Air Force Specialized Hospital, Cairo, Egypt

Status and phase: Active, not recruiting; Phase 4

Conditions: Multi Drug Resistant Infections

Treatments: Drug: Tigecycline once daily regimen; Drug: Usual doses of tigecycline

Study type: Interventional

Funder types: Other

Identifiers

NCT07258225

1.2025

Details and patient eligibility

About

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

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older.
• Both males and females.
• Diagnosis of infection has been established and tigecycline use is indicated (intra-abdominal, community-acquired pneumonia, skin Infections) or based on genetic testing and microbiological cultures (MDR Acinetobacter, MDR Stenotrophomonas, MDR Enterobacteriaceae, etc.)

Exclusion criteria

• Pregnancy and lactation.
• Bloodstream infections (BSI) and urinary tract infections (UTIs).
• Refusal of attending staff or patient, or family.
• Contraindications to tigecycline, such as hypersensitivity and allergy.
• Patients receiving ≤ 1 day of tigecycline (insufficient length of therapy).
• Patients who have acute physiology and chronic health evaluation (APACHE 2) score of more than 35 (high risk of mortality).
• Do not resuscitate/do not intubate (DNR, DNI) patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Control arm : Usual doses of tigecycline

Active Comparator group

Description:

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 a Child-Pugh score (C), the loading dose is 100 mg, then 25 mg every 12 hours

Treatment:

Drug: Usual doses of tigecycline

Tigecycline once daily regimen

Experimental group

Description:

Tigecycline once-daily regimen (100 mg once daily) or (200 mg once daily). For hepatic patients with Child-Pugh score (C), the loading dose is 100 mg then 50 mg every 24 hours.

Treatment:

Drug: Tigecycline once daily regimen