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Clinical Trials/EUCTR2012-000443-27-DE
EUCTR2012-000443-27-DE
Active, not recruiting
Phase 1

Determination of the penetration of antibiotics into epithelial lining fluid during continuous infusion in mechanically ventilated ICU patients: example meropenem

Dept. of Anesthesiology and Intensive Care, Charité - Campus Benjamin Franklin0 sites20 target enrollmentMarch 19, 2012
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Conditionspneumoniacomplicated urinary infectioncomplicated abdominal infectioncomplicated skin and soft tissue infectionacute bacterial meningitisMedDRA version: 20.0Level: LLTClassification code 10049582Term: Soft tissue infection NOSSystem Organ Class: 100000004862MedDRA version: 20.0Level: LLTClassification code 10040874Term: Skin infection NOSSystem Organ Class: 100000004862MedDRA version: 20.0Level: LLTClassification code 10046576Term: Urinary tract infection, site not specifiedSystem Organ Class: 100000004862MedDRA version: 22.1Level: LLTClassification code 10035725Term: Pneumonia NOSSystem Organ Class: 100000004862MedDRA version: 20.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsMeronem 1000 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
pneumoniacomplicated urinary infectioncomplicated abdominal infectioncomplicated skin and soft tissue infectionacute bacterial meningitis
Sponsor
Dept. of Anesthesiology and Intensive Care, Charité - Campus Benjamin Franklin
Enrollment
20
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 19, 2012
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dept. of Anesthesiology and Intensive Care, Charité - Campus Benjamin Franklin

Eligibility Criteria

Inclusion Criteria

  • •\- age 18 years or more
  • •\- mechanical ventilation via a endotracheal tube or cannula
  • •\- continuous infusion of an IMP prescribed by the attending physician due to suspected or proven infection
  • •\- informed consent by the patient or the legal representative
  • •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 10
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 10

Exclusion Criteria

  • •\- simultaneous participation in another clinical trial
  • •\- renal replacement therapy
  • •\- contraindications against bronchoscopy (e.g. coagulopathy, extremely compromised pulmonary gas exchange)
  • •\- hypersensitivity to meropenem or to other carbapenems
  • •\- severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to other betalactam antibiotics (e.g. penicillins, cephalosporins)

Outcomes

Primary Outcomes

Not specified

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