Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-21

Study Completion Date

2020-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

single-blind

Study Groups

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colistin-tigecycline

this 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 q12h

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

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

Tigecycline

Intervention Type DRUG

Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12

colistin-meropenem

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

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

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

Meropenem

Intervention Type DRUG

Intravenous meropenem 2 g IV infusion over 30 minutes q8 h

Interventions

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Colistin

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

Intervention Type DRUG

Meropenem

Intravenous meropenem 2 g IV infusion over 30 minutes q8 h

Intervention Type DRUG

Tigecycline

Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12

Intervention Type DRUG

Other Intervention Names

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polymixin B

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes