INFECTIONS DUE TO CARBAPENEM RESISTENT GRAM NEGATIVE BACTERIA MedDRA version: 14.1 Level: HLT Classification code 10004047 Term: Bacterial infections NEC System Organ Class: 100000004862
Conditions
Interventions
Trade Name: MERREM 500*IM FL 500MG+F 2ML
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: MEROPENEM
CAS Number: 96036-03-2
Concentration unit: g gram(s)
Concentration type:
Sponsors
RADBOUD UNIVERSITY NIJMEGEN MEDICAL CENTER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will include adult inpatients =18 years with clinically-significant infections as defined below caused by carbapenem-resistant and colistin-susceptible Gram-negative bacteria: Acinetobacter sp., P. aeruginosa or any Enterobacteriaceae (including but not limited to K. pneumoniae, E. coli and Enterobacter sp.). 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, regardless of the antibiotic treatment administered during this time period. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 162 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 162
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical success, 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: o for baseline SOFA = 3: a decrease of at least 30%; o for baseline SOFA 90 mmHg without need for vasopressor support • Stable or improved SOFA score, define as: o for baseline SOFA = 3: a decrease of at least 30%; o 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;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 14 and 28-day all-cause mortality • Clinical success, as defined above, but any modification to the antibiotic treatment not permitted by protocol will also be considered as failure. This will include any change or addition of antibiotics not permitted by study protocol. Early discontinuation of antibiotic treatment will not be considered as failure. • Time to defervescence, defined as time to reach a temperature of <38°C with no recurrence for 3 days;Timepoint(s) of evaluation of this end point: 14-28 days | — |
Countries
Israel, Italy
Contacts
Public ContactIst. di malattie infettive
Policlinico Gemelli
Outcome results
None listed