DeliriumCAD-CEFNCT07026253
Comparative Analysis of Delirium in Older Adults Treated With Ceftazidime, Cefepime, or Ceftriaxone
An observational study of Delirium, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patients aged 65 or older at Alexandria University Hospitals receiving Ceftriaxone, Ceftazidime, or Cefepime.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Main University Hospitals
Alexandria, Egypt, 21519
Rana Kh Draz, Pharm.D, EG + 1096209641 ext. +20, rana.draz90@gmail.com
Amr M. Salamah, Ph.D., Eg+ 1287219370 ext. +20, amrsalamah85@gmail.com
About this study
Official title: Comparative Analysis of Delirium in Older Patients Treated With Selected Antibiotics: a Prospective Cohort Study
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.
Read more
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.
Read the 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.
- Conditions
- Delirium
- Keywords
- cephalosporins, Antibiotics
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 days after initiation of antibiotic treatment
Secondary outcomes (4)
Delirium severity
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
Measured: On the day of delirium diagnosis
Length of hospital stay
Total number of days the patient remained hospitalized during the study period.
Measured: From hospital admission until discharge, assessed up to 90 days.
Mortality rate
Proportion of patients who died during hospitalization period.
Measured: From hospital admission until in-hospital death or discharge, assessed up to 90 days
Time to delirium onset
Number of days from the initiation of the antibiotic to the onset of clinically confirmed delirium (via Confusion Assessment Method [CAM]).
Measured: From the date of antibiotic initiation until the first documented CAM-positive delirium event, assessed up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Oct 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026253
- Sponsor's protocol ID
- 0108470
- Acronym
- CAD-CEF
- Status last verified
- Aug 2024
- First submitted
- 28 Apr 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Delirium in Older Patients Treated With Selected Antibiotics: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07026253
- Acronym / sponsor ID
- CAD-CEF / 0108470
- Conditions
- Delirium
- Keywords
- cephalosporins, Antibiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patients aged 65 or older at Alexandria University Hospitals receiving Ceftriaxone, Ceftazidime, or Cefepime.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Delirium severity
Time frame: On the day of delirium diagnosis
Length of hospital stay
Time frame: From hospital admission until discharge, assessed up to 90 days.
Mortality rate
Time frame: From hospital admission until in-hospital death or discharge, assessed up to 90 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Kh Draz, Pharm D. (1096209641 ext. +20, rana.draz90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Delirium Diagnosed by Confusion Assessment Method (CAM) (time frame: Within 6 days after initiation of antibiotic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.