Carbapenem-resistant Enterobacterales infections in hospitalized patients Infections and Infestations
Conditions
Interventions
Case group:
Arm A (control group):
Meropenem + colistin, the standard treatment for carbapenem-resistant enterobacterals (CRE) in Egypt.
Dosage given and frequency of administration:
Meropenem: sta
maximum dose: 2,000 mg/dose
Colistin: weight-based IV dosing per hospital protocol and renal function.
Mild to moderate infections: 75,000 IU/kg every 12 hours in normal renal function.
Severe or life
Sponsors
Cairo University hospitals
Eligibility
Sex/Gender
All
Age
3 Months to 16 Years
Inclusion criteria
Inclusion criteria: 1. Age more than 3 months for both sexes 2. Hospitalized patients with a proven infection 3. Culture or BioFire showed carbapenem-resistant Enterobacterales (CRE)
Exclusion criteria
Exclusion criteria: 1. Co-infection with other microorganisms in conjunction with CRE 2. Empirical use 3. Duration of treatment combination is less than 48 hours 4. Expected survival is less than 48 hours 5. Known allergy to study drugs 6. Renal replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate measured using the resolution of symptoms and no need for antibiotic change at days 7-14;Microbiological eradication measured using follow-up cultures at days 7 and 14;Mortality measured using the total number of infection-related deaths in that arm divided by the total number of enrolled patients in that arm and multiplying by 100 at days 7, 14 and 28;Time to fever resolution measured using a thermometer at baseline and over 72 hours;Length of ICU Stay (LOS) at hospital discharge and up to 90 days, defined as the median of the number of days in the ICU from admission until discharge, measured using data from records, collected at one timepoint at the end of the study;Incidence of acute kidney injury (AKI) measured using the Kidney Disease Improving Global Outcomes (KDIGO) criteria at baseline and during the therapy duration;Adverse events (nephrotoxicity, hepatotoxicity, hypersensitivity reactions, and other treatment-related adverse events) throughout the treatment period (7-14 days) and up to 72 hours after the follow-up period measured using routine clinical practice during hospitalisation (nephrotoxicity and hepatotoxicity) and data recording, collected at one timepoint at the end of the study;Sepsis markers measured using WBC count, CRP, platelet count, and shift left count at baseline and every other day for 14 days | — |
Countries
Egypt
Contacts
Public ContactWalaa Elmeniar
Outcome results
None listed