Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen (NCT07258225) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen
Egypt86 participantsStarted 2024-04-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare treatment outcomes (clinical response) of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen). composite endpoint
Timeframe: 28 days
2
Compare the safety of the tigecycline once-daily regimen and the standard regimen (twice-daily regimen).
Timeframe: 28 days
Trial details
NCT IDNCT07258225
SponsorAir Force Specialized Hospital, Cairo, Egypt