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NCT Number: NCT07258225

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Multi Drug Resistant Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Air force specialized hospital

Cairo, Cairo Governorate, 11765, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

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

    Time frame: 28 days

    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

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

    Time frame: 28 days

    • 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.

    .

Secondary outcomes

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

    Time frame: 28 days

    Calculate the percentage of dead patients in the two groups

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

    Time frame: 28 days

    Comparing the increase or decrease in CRP level (mg/L)

  3. Vasopressor needs (only in septic shock patients).

    Time frame: 28 days

    Comparing the duration of vasopressor need between the two groups

  4. Compare the incidence of tigecycline-induced vomiting between the two groups

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Air Force Specialized Hospital, Cairo, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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