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

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gram-Negative Bacterial Infections

Intervention: Colistin (Drug); Meropenem (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Mical Paul

Official(s) and/or principal investigator(s):
Johan Mouton, MD PhD, Study Chair, Affiliation: Radboud University
Mical Paul, MD, Principal Investigator, Affiliation: Rambam Health Care Centre

Overall contact:
Mical Paul, MD, Email: paulm@post.tau.ac.il

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical success

Secondary outcome:

Secondary outcomes and adverse events

Clinical success with modification

Time to defervescence

Time to weaning

Time to hospital discharge

Microbiological failure

Superinfections

New resistant infection

CDAD

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Mical Paul, MD, Email: paulm@post.tau.ac.il

Atikkon Hospital, Athens, Greece; Recruiting
Diamantis Plachouras, MD
Diamantis Plachouras, MD PhD, Principal Investigator

Laikon Hosptial, Athens, Greece; Recruiting
Diamantis Plachouras, MD PhD
Diamantis Plachouras, MD PhD, Principal Investigator

Rambam Health Care Center, Haifa, Israel; Recruiting
Mical Paul, MD
Mical Paul, MD, Principal Investigator

Rabin Medical Center, Petach-Tikvah, Israel; Recruiting
Leonard Leibovici, MD
Leonard Leibovici, MD, Principal Investigator

Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel; Recruiting
Yehuda Carmeli, MD
Yehuda Carmeli, MD, Principal Investigator

Monaldi Hospital, University of Naples S.U.N., Naples, Italy; Recruiting
Emanuele Durante Mangoni, MD, Email: emanuele.durante@unina2.it
Riccardo Utili, MD, Email: riccardo.utili@ospedalemonaldi.it

Agostino Gemelli Hospital, Rome, Italy; Terminated

Additional Information

Starting date: March 2013
Last updated: February 14, 2015

Page last updated: August 23, 2015

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