Skip to main content
OpenTrials
Completed

NCT Number: NCT01732250

Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem

The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Atikkon Hospital, Athens, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult inpatients
  • Clinically significant, microbiological-documented infection caused by carbapenem-resistant and colistin-susceptible Gram-negative bacteria and identified according to CDC criteria- blood stream infections, hospital acquired pneumonia, ventilator associated pneumonia, and urinary tract infections
  • Patient recruitment will occur only after microbiological documentation and susceptibility testing. Patients will be included within 96 hours of the time the index culture was taken (typically within 48 hours of isolate identification), regardless of the antibiotic treatment administered during this time period.

Exclusion criteria

  • Previous inclusion in the trial. Patients will be included in the RCT only once for the first identified episode of infection
  • Pregnant women
  • Epilepsy or prior seizures
  • Known allergy to colistin or a carbapenem

Treatment and study plan

Colistin

Drug

IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function, for 10 days.

Other names: Colistimethate Sodium, Coliracin

Meropenem

Drug

IV meropenem, 2 gram q8h, adjusted for renal function, for up to 10 days.

Other names: Meronem

Primary outcomes

  1. Clinical success

    Time frame: 14 days

    defined as a composite of all of the following, all measured at 14 days:

    • Patient alive
    • Systolic blood pressure >90 mmHg without need for vasopressor support
    • Stable or improved SOFA score, define as:
    • for baseline SOFA ≥ 3: a decrease of at least 30%;
    • for baseline SOFA <3: stable or decreased SOFA score
    • For patients with HAP/ VAP, PaO2/FiO2 ratio stable or improved
    • For patients with bacteremia, no growth of the initial isolate in blood cultures taken on day 14 if patient still febrile

Secondary outcomes

  1. Secondary outcomes and adverse events

    Time frame: 14 and 28 days

    14 and 28-day all-cause mortality.

    If patients are discharged or death occurs before end of follow-up (day 28), we will end data collection at that date. We will attempt to determine survival status at day 28 for all patients (central registry in Israel; re-admissions, rehabilitation centers, hospital transfers in Greece and Italy).

  2. Clinical success with modification

    Time frame: 14 days

    Clinical success, but with modification to the antibiotic treatment not permitted by protocol

  3. Time to defervescence

    Time frame: 28 days

    defined as time to reach a temperature of <38°C with no recurrence for 3 days

  4. Time to weaning

    Time frame: 28 days

    Time to weaning from mechanical ventilation in VAP for patients weaned alive

  5. Time to hospital discharge

    Time frame: 28 days

    Time to hospital discharge for patient discharged alive

  6. Microbiological failure

    Time frame: 28 days

    Microbiological failure, defined as isolation of the initial isolate (phenotypically identical) in a clinical sample (blood or other) 7 days or more after start of treatment or its identification in respiratory samples.

    • For all patients with VAP/ HAP sputum or tracheal aspirates will be obtained on day 7, regardless of clinical response
    • For all patients with UTI, a repeat urine culture will be obtained on day 7, regardless of clinical response
    • For patients with bacteremia, blood cultures will be repeated on day 7 and 14, only if the patient is febrile at that time

  7. Superinfections

    Time frame: 28 days

    Defined as a new clinically or microbiologically-documented infections by CDC criteria within 28 days

  8. New resistant infection

    Time frame: 28 days

    Colonization or infection by newly-acquired (other species than the initial infection) carbapenem-resistant or colistin-resistant Gram-negative bacteria. Colonization will be assessed by rectal surveillance

  9. CDAD

    Time frame: 28 days

    Clostridium-difficile-associated diarrhea, defined by diarrhea with a positive C. difficile toxin test

Sponsors and collaborators

Lead sponsor

Mical Paul

Other

Collaborators

  • European Commission

Registry information

Official study title

Multicenter Open-label RCT to Compare Colistin Alone vs. Colistin Plus Meropenem

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2012
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.