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

NCT07258225 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 1.2025
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Once daily tigecycline; High dose tigecycline; Tigecycline safety; Tigecycline efficacy

Outcome Measures

Primary Outcomes (2)

• Compare treatment outcomes (clinical response) of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). composite endpoint

  Composite clinical response, defined as improvement of inflammatory markers (CRP, Procalcitonin), clinical improvement permitting ICU discharge, and absence of need to modify tigecycline therapy (no escalation or addition of other antibiotics), will be assessed at different time points during the study period. The response is classified as 1- Treatment success (Cure) by improvement of the SOFA score, improvement of infection markers ( CRP, Procalcitonin), and by the need for ICU stay ( ICU length of stay) 2- Treatment failure by an increase of SOFA score, an increase of infection markers ( CRP, Procalcitonin), need to change tigecycline to another antibiotic, or to add on another antibiotic, and death 3) Indeterminate response for drop-out patients and incomplete minimal duration of therapy

  28 days

• Compare the safety of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen).

  1\. Tigecycline-induced hyperbilirubinemia will be assessed by comparing the baseline bilirubin level to the follow-up level at determined intervals (3 days, 5 days), allowing for comparison of the incidence of hyperbilirubinemia between the two study groups. .

  28 days

Secondary Outcomes (4)

• - Intensive care unit (ICU) and in-hospital mortality between the two groups.

  28 days

• Infection markers change between the two groups (C-reactive protein (CRP)

  28 days

• Vasopressor needs (only in septic shock patients).

  28 days

• Compare the incidence of tigecycline-induced vomiting between the two groups

  28 days

Study Arms (2)

Control arm : Usual doses of tigecycline

ACTIVE COMPARATOR

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

Drug: Usual doses of tigecycline

Tigecycline once daily regimen

EXPERIMENTAL

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.

Drug: Tigecycline once daily regimen

Interventions

Tigecycline once daily regimen DRUG

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.

Tigecycline once daily regimen

Usual doses of tigecycline DRUG

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

Control arm : Usual doses of tigecycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Specialized Hospital, Cairo, Egypt: lead

Study Sites (1)

Air force specialized hospital

Cairo, Cairo Governorate, 11765, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 2, 2025
• Study Start: April 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: April 30, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

EG (1)