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

NCT07026253 | Recruiting

• 1 other identifier: 0108470
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

cephalosporins; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Incidence of Delirium Diagnosed by Confusion Assessment Method (CAM)

  : 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.

  Within 6 days after initiation of antibiotic treatment

Secondary Outcomes (4)

• Delirium severity

  On the day of delirium diagnosis

• Length of hospital stay

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

• Mortality rate

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

• Time to delirium onset

  From the date of antibiotic initiation until the first documented CAM-positive delirium event, assessed up to 6 days

Study Arms (3)

Ceftazidime Group

A cohort of at least 40 older-adult patients (≥65 years) receiving ceftazidime for the treatment of various infections.

Cefepime Group

A group of a minimum of 40 elderly patients treated with cefepime for confirmed or suspected infections.

Ceftriaxone Group

This cohort will include at least 40 older adult inpatients receiving ceftriaxone as part of their anti-infective regimen

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients aged 65 or older at Alexandria University Hospitals receiving Ceftriaxone, Ceftazidime, or Cefepime.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main University Hospitals

Alexandria, Egypt, 21519, Egypt

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rana Kh Draz, Pharm D.

CONTACT

1096209641; rana.draz90@gmail.com

Noha A Hamdy, Ph.D

CONTACT

1005182151; noha.alaaeldine@alexu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 18, 2025
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 18, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)