Status:
UNKNOWN
Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae
Lead Sponsor:
Al-Azhar University
Conditions:
Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
This prospective, comparative study is evaluating the effectiveness and adverse effects of using colistin at a loading dose of 9 million international units (MIU) followed by 4.5 MIU every 12 h (q12 h...
Eligibility Criteria
Inclusion
- Patients with blood stream infection caused by MDR K. pneumoniae, as defined by Infectious Diseases Society of America (IDSA), who were hospitalised in the general ICU, confirmed with carbapenem-resistant K. pneumoniae-positive culture results from blood sample within the previous 5 days
Exclusion
- All patients without a MDR carbapenem-resistant K. pneumoniae-positive culture isolated from the blood. In addition, the following patients are excluded: patients with a Glasgow Coma Scale (GCS) score of \<9 in non-ventilated patients or \<6 in ventilated patients; patients with end-stage metastatic malignant cancer; and all terminal patients with Acute Physiology and Chronic Health Evaluation (APACHE) II or Sequential Organ Failure Assessment (SOFA) scores of \>34 or \>15, respectively, and risk of mortality \>85% or \>80% on the first day of colistin administration, respectively \[27,28\]. Moreover, patients who received i.v. colistin combination therapies for \<72 h are excluded from further analysis
Key Trial Info
Start Date :
September 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04489459
Start Date
September 21 2019
End Date
July 1 2020
Last Update
July 29 2020
Active Locations (1)
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1
Qasr El Ainy
Cairo, Egypt