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Clinical Trials/EUCTR2018-000450-21-ES
EUCTR2018-000450-21-ESActive, not recruitingPhase 1

Prospective, Randomized, Open, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of the MON4STRAT Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients with Gram-Negative Lower Respiratory Tract Infection Including Nosocomial Pneumonia and Severe Tracheobronchitis - MONS4STRAT

Fundación Investigación Biomédica Hospital Ramón y Cajal0 sites50 target enrollmentStarted: February 15, 2018Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
50
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •The inclusion criteria are the following (all should be fulfilled):
  • •1.Males and non-pregnant, non-lactating females, 18 years of age or older
  • •2.Currently intubated and mechanically-ventilated subjects in the ICU
  • •3.Suspicion of lower respiratory tract infection defined as at least two of the following:
  • •?fever, defined as a tympanic/ rectal/core temperature > 38,3°C , or hypothermia, defined as a rectal/core body temperature of < 35,0°C;
  • •?leukocyte count > 10 000/mm3 or < 4 500/mm3, or an immature neutrophil (band) count > 15% regardless of the peripheral leukocyte count;
  • •?new onset of purulent sputum or respiratory secretions, or a change in the character of sputum;
  • •?a new or progressive pulmonary infiltrate on chest X-rays.
  • •4.Presence of Gram-negative organism(s) by Gram stain OR by culture of pre-therapy respiratory specimen (eg, endotracheal aspirate [ETA], bronchoalveolar lavage [BAL], or mini-BAL) OR previous colonization 48h before screening.
  • •5.Initial empiric antimicrobial regimen combining meropenem with an aminoglycoside or a fluoroquinolone active on Pseudomonas, plus MRSA coverage when indicated, in accordance with the ATS/IDSA guidelines for HAP/VAP/HCAP.
  • •6.At least two risk factors for multidrug-resistant organisms:
  • •?Antimicrobial therapy in the preceding two weeks;
  • •?Current hospitalization = 5 days;
  • •?High frequency (> 10%) of antibiotic resistance in the community or in the specific hospital unit;
  • •?Immunosuppressive disease and/or therapy;
  • •?Residence in a nursing home or extended care facility.
  • •7.Clinical pulmonary infection score (CPIS) = 6
  • •8.Expected to remain intubated and mechanically ventilated for = 72 hours based on investigator estimate.
  • •9.Expected to participate in the study through 28 days post first dose of meropenem.
  • •10.Provision of written informed consent by the subject or a family member or a close relative within 36 hours after the beginning of the initial antibiotic therapy. [A waiver of consent will be asked to each Ethical Committee allowing for randomizing patients when they are unable to give consent and no, family member or a close relative can be contacted, in accordance with law specifications of emergency consent. In that case, patients will be asked to give their consent for continuation of the trial when their condition permits].
  • •11.In order to be eligible for the primary microbiologically evaluable population (Micro-ITT Analysis Set), subjects must demonstrate presence of Gram-negative organism(s) by semi-quantitative or quantitative cultures of pre-therapy respiratory secretions in concentrations above prespecified values (ETA cultures =105 CFU/mL; BAL cultures =104 CFU/mL)
  • •12.Affiliation to a social security system (recipient or assign)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 35
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

  • •Any of the following would exclude the subject from participation in the study:
  • •1.Subjects who have received antibiotic therapy for Gram-negative LRT infection for =36 hours at the time of randomization
  • •2.Subjects with known or suspected type 1 hypersensitivity (e.g., anaphylaxis) to betalactam and/or cephalosporin
  • •3.Infection caused by a pathogen resistant to meropenem
  • •4.Subjects taking valproic acid for a seizure disorder will not be included. Other anticonvulsants are allowed.
  • •5.Subjects who have had a left hemisphere stroke (right hemisphere is allowed) within five days and there is an increased risk of fatal brain oedema as indicated by a major early computerized tomography hypodensity exceeding 50% of the middle cerebral artery territory, and/or involvement of additional vascular territories
  • •6.Subjects who have cystic fibrosis, human immunodeficiency virus (HIV) infection with CD4 count < 100 cell/mm3 (HIV testing is not required as part of this protocol), or invasive fungal infection of the lung
  • •7.Neutropenia (screening absolute neutrophil count < 103 neutrophils/mm3)
  • •8.Bone marrow transplant
  • •9.Subjects who have primary lung cancer with known endobronchial obstruction (postoperative patients after lung cancer resection are eligible for the study)
  • •10.Subjects with another focus of infection requiring concurrent antibiotics that would interfere with evaluation of the response to study treatment
  • •11.Subjects for whom therapy will require aerosolized antibiotics
  • •12.Subjects for whom therapy will require intermittent hemodialysis (patients treated with continuous renal replacement techniques are eligible for the study)
  • •13.Subjects only infected by Haemophilus spp.
  • •14.Burns greater than 40% of total body surface area
  • •15.Subjects with intractable septic shock (subjects requiring ongoing treatment with vasopressors will be eligible for the study if their hypotension is controlled and profound acidosis has resolved)
  • •16.Rapidly fatal illness with death likely within the next 72 hours
  • •17.Subjects who have been on mechanical ventilation for >28 days
  • •18.Subjects who were previously enrolled in this study
  • •19.Patients under curatorship or tutorship

Investigators

Sponsor
Fundación Investigación Biomédica Hospital Ramón y Cajal

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