Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae Clinical Trial
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
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) + 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 4.5 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 4.5 MIU IV infusion over 2 hours q12 h plus
Intravenous meropenem 2 g IV infusion over 30 minutes q8 h
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