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

July 27, 2020 updated by: Salma Wagih Abdalla, Al-Azhar University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Qasr El Ainy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Drug: 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
Other Names:
  • polymixin B
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
ACTIVE_COMPARATOR: 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
Drug: 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
Other Names:
  • polymixin B
Drug: Meropenem
Intravenous meropenem 2 g IV infusion over 30 minutes q8 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 7-14 days
7-14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparing comorbidities:nephrotoxicity,hepatotoxicity,neurotoxicity,hematological changes between critically ill patients with MDR Gram-negative Klebsiella pneumoniae infection treated with colistin-tigecycline vs colistin-meropenem
Time Frame: 7-14 days
7-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2019

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (ACTUAL)

July 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D12019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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