Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04489459
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-07-24
Brief Title:
Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 45 MIU every 12 h q12 h tigecycline at a loading dose of 100 mg followed by 50 mg every 12 h q12 h versus colistin meropenem 2 g q8 h in treating blood stream infections due to multidrug-resistant MDR Klebsiella pneumoniae The aims of the current study are to investigate and evaluate the therapeutic activity and side effects of Colistin-Meropenem combined therapy versus Colistin-Tigecycline combined therapy in treatment of patients with Multiple Drug Resistant MDR-Klebsiella pneumonia bacteraemia The primary goal is comparing 14 day mortality between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection as evaluation of the therapeutic activity of colistin - tigecycline vs colistin - meropenem combined therapies The secondary goal is comparing the comorbidities nephrotoxicity hepatotoxicity neurotoxicity hematological changes between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection who will be treated with colistin - tigecycline versus colistin - meropenem combined therapies
Method A total of 60 patients were divided into two groups 30 patients each the first group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 45 MIU IV infusion over 2 hours q12 h plus Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12 and the second group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 45 MIU IV infusion over 2 hours q12 h plus Intravenous meropenem 2 g IV infusion over 30 minutes q8 h
Method A total of 60 patients were divided into two groups 30 patients each the first group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 45 MIU IV infusion over 2 hours q12 h plus Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12 and the second group received Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 45 MIU IV infusion over 2 hours q12 h plus Intravenous meropenem 2 g IV infusion over 30 minutes q8 h
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None