Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Hospitalized patients aged 65 or older at Alexandria University Hospitals receiving Ceftriaxone, Ceftazidime, or Cefepime.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rana Kh Draz, Pharm D. | Contact | 1096209641 | +20 | rana.draz90@gmail.com |
| Noha A Hamdy, Ph.D | Contact | 1005182151 | +20 | noha.alaaeldine@alexu.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria Main University Hospitals | Recruiting | Alexandria | Egypt | 21519 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| On the day of delirium diagnosis |
| Length of hospital stay | Total number of days the patient remained hospitalized during the study period. | From hospital admission until discharge, assessed up to 90 days. |
| Mortality rate | Proportion of patients who died during hospitalization period. | 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]). | From the date of antibiotic initiation until the first documented CAM-positive delirium event, assessed up to 6 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |