Multi Drug Resistant Infections
Conditions
Keywords
Once daily tigecycline, High dose tigecycline, Tigecycline safety, Tigecycline efficacy
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
Interventions
DRUGTigecycline 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.
DRUGUsual 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
Sponsors
Air Force Specialized Hospital, Cairo, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare treatment outcomes (clinical response) of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). composite endpoint | 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 |
| Compare the safety of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). | 28 days | 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. . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - Intensive care unit (ICU) and in-hospital mortality between the two groups. | 28 days | Calculate the percentage of dead patients in the two groups |
| Infection markers change between the two groups (C-reactive protein (CRP) | 28 days | Comparing the increase or decrease in CRP level (mg/L) |
| Vasopressor needs (only in septic shock patients). | 28 days | Comparing the duration of vasopressor need between the two groups |
| Compare the incidence of tigecycline-induced vomiting between the two groups | 28 days | — |
Countries
Egypt
Outcome results
None listed