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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Multi Drug Resistant Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

Group Type ACTIVE_COMPARATOR

Usual doses of tigecycline

Intervention Type 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

Tigecycline once daily regimen

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.

Group Type EXPERIMENTAL

Tigecycline once daily regimen

Intervention Type 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.

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No