Clinical Trials to Reduce the Risk of Antimicrobial Resistance

NCT01570192 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 10-0060
• Study Type: interventional
• Target: 43
• Locations: 4 countries
• Sites: 11

Brief Summary

The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).

Conditions

Bacterial Pneumonia

Keywords

gram negative pathogens; Pseudomonas aeruginosa; Acinetobacter; HCAP; VABP; HABP

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Suppression and Emergence of Resistance

  The emergence of resistance is defined as a change of meropenem MIC or aminoglycoside MIC by two tube dilutions (fourfold) from baseline when assessed at the second BAL procedure on day 5/early extubation. Patients are evaluable for this endpoint IF they had baseline BAL and Day 5/early extubation and if they had positive cultures on baseline and Day/EE.

  up to 28 days after enrollment

Secondary Outcomes (8)

• Clinical Response

  End of treatment - up to 28 days after enrollment

• Clinical Response in Subjects Who Received Prior Antibiotics

  End of treatment - up to 28 days after enrollment

• Overall Microbiologic Response

  End of treatment - up to 28 days after enrollment

• Pretreatment Pathogen Response

  End of treatment - up to 28 days after enrollment

• Suppression of the Emergence of Resistance in Other Gram-negative Pathogens

  Day 5/Early Extubation

Study Arms (2)

IV meropenem; parenteral aminoglycoside

EXPERIMENTAL

Subjects assigned to this group will receive: * IV meropenem (2 g infused over 3 hrs q 8 hr); * a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h) * tobramycin nebulization Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.

Drug: IV meropenem; Drug: Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h; Drug: Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage.; Device: tobramycin nebulization

I.V. Meropenem

ACTIVE COMPARATOR

Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr). Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens. \*\*NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.

Drug: I.V. Meropenem; Drug: Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage.

Interventions

I.V. Meropenem DRUG

Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr). Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage

Also known as: Merrem I.V.

I.V. Meropenem

Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h DRUG

a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)

IV meropenem; parenteral aminoglycoside

Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage. DRUG

Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.

I.V. Meropenem; IV meropenem; parenteral aminoglycoside

tobramycin nebulization DEVICE

tobramycin nebulization 600mg/day

IV meropenem; parenteral aminoglycoside

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent by the subject/subject's LAR.
• Hospitalized males or females ≥ 18 yrs with respiratory failure requiring mechanical ventilation and clinical suspicion of HABP, HCAP or VABP.
• Onset or exacerbation of pneumonia at least 48 hours after admission to any patient health care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility
• Women of childbearing potential if their pregnancy test is negative
• Subjects who have received previous antibacterial therapy within 14 days of pre-treatment bronchoscopy entry may be entered only if the subject has not responded clinically.). While less than 24 hours of pre-treatment antibiotics is preferential, recovery of \>104 CFU/ml in the quantitative Bronchoscopic BAL will be seen as primary evidence that the prior therapy was not efficacious and enrollment will be allowed.)
• Patients should have clinical findings that support a diagnosis of HABP/VABP/HCAP:
• Within 48 hours before starting empiric therapy a subject's chest radiograph should show the presence of a NEW or progressive infiltrate, cavitation, or effusion suggestive of pneumonia
• Within 36 hours before the start of empiric study therapy, a quantitative culture of Bronchoscopic BAL fluid must be obtained.
• Patients with VABP should have a Clinical Pulmonary Infection Score of \>/= 5.

You may not qualify if:

• Subjects with pneumonia caused by pathogens resistant to meropenem (MIC greater than or equal to 16µg/ml) or a prior meropenem therapy failure.
• Subjects with contra-indications to ANY study medication, in particular with known or suspected allergy or hypersensitivity.
• Women who are pregnant or lactating.
• Subjects taking anticonvulsant medications for a known seizure disorder.Patients with a history of seizures, AND who are stabilized on anti-seizure medication, may be enrolled into the study at the discretion of the site investigator.
• Subjects with known or suspected community acquired bacterial pneumonia (CABP) or viral pneumonia; or Subjects with acute exacerbation of chronic bronchitis without evidence of pneumonia.
• Subjects with primary lung cancer or another malignancy metastatic to the lungs.
• Subjects who were previously enrolled in this study.
• Subjects who have had an investigational drug or have used an investigational device within 30 days prior to entering the study.
• Subjects with another focus of infection requiring concurrent antibiotics that would interfere with evaluation of the response to study drug.
• Subjects with cystic fibrosis, AIDS with a CD4 lymphocyte count \<200 cells/µl, neutropenia (absolute neutrophil count \<500 cells/ml), known or suspected active tuberculosis.
• Subjects with little chance of survival for the duration of study therapy.
• Subjects with an APACHE II score \>35.
• Subjects with underlying condition(s) which would make it difficult to interpret response to the study drugs.
• Subjects with hypotension or acidosis despite attempts at fluid resuscitation. Subjects requiring ongoing treatment with vasopressors will be eligible for the study if their hypotension is controlled and acidosis has resolved. Subjects with intractable septic shock are not eligible for enrollment.
• Subjects who have undergone bone marrow transplantation.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (11)

InClin, Inc.

San Mateo, California, 94403, United States

Location

UFL Department of Medicine: Pulmonary, Critical Care and Sleep Medicine

Gainesville, Florida, 32610, United States

Location

Emory University

Atlanta, Georgia, 30322-4250, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

JMI Laboratories

North Liberty, Iowa, 52317, United States

Location

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63130, United States

Location

Weill Cornell Medical Center of Cornell University

New York, New York, 10065, United States

Location

Cleveland Clinic Lerner College of Medicine

Cleveland, Ohio, 44195, United States

Location

Institut de Cardiologie, Groupe Hospitalier Pitie-Salpetriere

Paris, Cedex 13, France

Location

Hannover Clinical Trial Center GmbH

Hanover, 30625, Germany

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (49)

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  PMID: 29038277 DERIVED

MeSH Terms

Conditions

Pneumonia, Bacterial; Pseudomonas Infections

Interventions

Meropenem; Tobramycin; Linezolid; Vancomycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Gram-Negative Bacterial Infections

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Acetamides; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. George L. Drusano
• Organization: University of Florida, Department of Medicine

gdrusano@ufl.edu

407-313-7060

Study Officials

• George L Drusano, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is an open-label study with 1:1 randomization between two active treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: April 4, 2012
• Study Start: September 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 29, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); FR (1); ES (1); US (8)