Comparative Analysis of Delirium in Older Adults Treated With Ceftazidime, Cefepime, or Ceftriaxone

Recruiting

• Conditions: Delirium

• Registration Number: NCT07026253
• Lead Sponsor: Alexandria University

Brief Summary

The goal of this observational study is to learn if the use of ceftazidime, cefepime, and ceftriaxone impacts the incidence of delirium in elderly patients (aged 65 and older) with infections. The main questions it aims to answer are:

Does the administration of these antibiotics increase the incidence of delirium in elderly patients? How do renal and hepatic dose adjustments affect the likelihood of delirium? Researchers will observe elderly patients receiving either ceftazidime, cefepime, or ceftriaxone for infection management to see if these antibiotics contribute to the onset of delirium, and then assessing the severity of the delirium.

Participants will:

Be assessed for delirium using the CAM (Confusion Assessment Method) at 2, 4, and 6 days after starting treatment.

Have their QSOFA (Quick Sequential Organ Failure Assessment) and NEWS (National Early Warning Score) tracked to evaluate their overall health status.

Undergo dose adjustments based on renal and hepatic function as part of their treatment.

Use the DRS.R89 score to assess delirium if it occurred.

Detailed Description

This observational study aims to assess the incidence, severity, and recovery of delirium in older adult patients treated with ceftazidime, cefepime, or ceftriaxone for infections. Delirium onset and severity will be monitored using the Confusion Assessment Method (CAM) and the Delirium Rating Scale (DRS-R98), alongside the Sequential Organ Failure Assessment (SOFA) scores, and National Early Warning Score (NEWS) for assessing the severity of infection. Key variables include the presence of delirium at Days 2, 4, and 6, and evaluating the severity of delirium and recovery time, as well as the impact of renal and hepatic dose adjustments. By examining these factors, the study seeks to provide insights into safer antibiotic use and dosing strategies in elderly patients, with the goal of reducing delirium risk and improving patient outcomes.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-10-01
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Older adult patients aged 65 years or above.
• Hospitalized patients in Alexandria university hospitals diagnosed with infection and treated with selected cephalosporins (Ceftriaxone, Ceftazidime, or Cefepime).
• Patients without a history of Pre-existing delirium prior to hospitalization.

Exclusion Criteria

• Patients with contraindications or allergies to cephalosporins.
• Patients with septic shock.
• Current use of medications known to cause delirium (anticholinergics, benzodiazepines, or opioid analgesics).
• Current or recent substance abuse (patients with a history of alcohol or drug abuse within the past year, or currently undergoing withdrawal). 5. Recent surgical procedures (patients who have undergone major surgery, particularly those requiring general anesthesia, within the last 30 days).
• Electrolyte imbalance (patients with severe electrolyte disturbances such as hypernatremia, hyponatremia, hypercalcemia or hypocalcemia at the time of study entry).
• Patients with End-stage renal disease requiring dialysis.
• Patients with severe liver disease (e.g., Child-C).
• Pain management issues: Patients with severe, uncontrolled pain that might independently affect cognitive function.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Delirium Diagnosed by Confusion Assessment Method (CAM)	Within 6 days after initiation of antibiotic treatment	: Determine the incidence of delirium in older-adult patients treated with selected cephalosporins, diagnosed using the Confusion Assessment Method (CAM).; Units of Measure: Number of participants with CAM-positive delirium Details: The CAM is a validated diagnostic tool for delirium based on four features: (1) acute onset and fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. Delirium is diagnosed when both features 1 and 2 are present, and either feature 3 or 4.; Incidence will be calculated as the number of patients who meet the CAM criteria divided by the total number of patients in each treatment arm.

Secondary Outcome Measures

Name	Time	Method
Delirium severity	On the day of delirium diagnosis	Description: Severity of delirium measured using the Delirium Rating Scale-Revised-98 (DRS-R-98).; Units of Measure: DRS-R-98 score (0-39 for severity scale) Delirium Rating Scale-Revised-98 (DRS-R-98) is a standardized tool used to assess the severity and presence of delirium. It includes 16 items - 13 severity items and 3 diagnostic items - and is rated based on clinical observation and patient interaction.; Scoring Overview: 13 severity items are scored from 0 to 3 (maximum score = 39) 3 diagnostic items are scored from 0 to 3 (maximum score = 9) Total maximum score = 46
Length of hospital stay	From hospital admission until discharge, assessed up to 90 days.	Total number of days the patient remained hospitalized during the study period.
Mortality rate	From hospital admission until in-hospital death or discharge, assessed up to 90 days	Proportion of patients who died during hospitalization period.
Time to delirium onset	From the date of antibiotic initiation until the first documented CAM-positive delirium event, assessed up to 6 days	Number of days from the initiation of the antibiotic to the onset of clinically confirmed delirium (via Confusion Assessment Method \[CAM\]).

Trial Locations

Locations (1)

Alexandria Main University Hospitals; 🇪🇬 Alexandria, Egypt