Actively Recruiting
Comparative Analysis of Delirium in Older Patients Treated With Selected Antibiotics: a Prospective Cohort Study
Led by Alexandria University · Updated on 2025-06-18
120
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the use of the antibiotics ceftazidime, cefepime, and ceftriaxone affects the development of delirium in elderly patients aged 65 and older who are being treated for infections. This observational study aims to understand if these antibiotics increase delirium risk, how dose adjustments based on kidney and liver function impact this risk, and the severity and recovery time of delirium in this population. The study involves three groups of hospitalized older adults receiving one of the three antibiotics: ceftazidime, cefepime, or ceftriaxone. Each group will include at least 40 patients treated for infections. Researchers will observe the patients' antibiotic dosing, including any renal and hepatic adjustments, throughout their infection management. Participants will be assessed for delirium using the Confusion Assessment Method (CAM) at days 2, 4, and 6 after starting antibiotic treatment. Their overall health status will be tracked using scores like QSOFA and NEWS. If delirium occurs, its severity will be measured using the Delirium Rating Scale (DRS-R98). The study will also monitor length of hospital stay, mortality rate, and time to delirium onset, with follow-up assessments up to 90 days after hospital admission.
CONDITIONS
Brief Title
Comparative Analysis of Delirium in Older Adults Treated With Ceftazidime, Cefepime, or Ceftriaxone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older adult patients aged 65 years or above
- Hospitalized patients diagnosed with infection and treated with ceftriaxone, ceftazidime, or cefepime
- Patients without a history of delirium prior to hospitalization
You will not qualify if you...
- Patients allergic or with contraindications to cephalosporins
- Patients with septic shock
- Current use of medications known to cause delirium such as anticholinergics, benzodiazepines, or opioid analgesics
- Patients with current or recent substance abuse within the past year or undergoing withdrawal
- Patients who had major surgery requiring general anesthesia within the last 30 days
- Patients with severe electrolyte imbalances such as hypernatremia, hyponatremia, hypercalcemia, or hypocalcemia
- Patients with end-stage renal disease requiring dialysis
- Patients with severe liver disease (e.g., Child-C)
- Patients with severe uncontrolled pain that could affect cognitive function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 days after antibiotic initiation
Participants treated with ceftazidime, cefepime, or ceftriaxone are observed for the onset, severity, and recovery of delirium using specific assessment methods.
Assessments on Days 2, 4, and 6
Duration - Up to 90 days from hospital admission
Participants are followed to assess length of hospital stay and mortality up to 90 days after admission.
Visits as per hospital stay and discharge
Trial Site Locations
Total: 1 location
1
Alexandria Main University Hospitals
Alexandria, Egypt, Egypt, 21519
Actively Recruiting
Research Team
R
Rana Kh Draz, Pharm D.
N
Noha A Hamdy, Ph.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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