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NCT Number: NCT07026253

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

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria Main University Hospitals

Alexandria, Egypt, 21519

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Delirium Diagnosed by Confusion Assessment Method (CAM)

    Time frame: 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 outcomes

  1. Delirium severity

    Time frame: 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

  2. Length of hospital stay

    Time frame: From hospital admission until discharge, assessed up to 90 days.

    Total number of days the patient remained hospitalized during the study period.

  3. Mortality rate

    Time frame: From hospital admission until in-hospital death or discharge, assessed up to 90 days

    Proportion of patients who died during hospitalization period.

  4. Time to delirium onset

    Time frame: 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]).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Comparative Analysis of Delirium in Older Patients Treated With Selected Antibiotics: a Prospective Cohort Study

Acronym: CAD-CEF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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