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Clinical Trials to Reduce the Risk of Antimicrobial Resistance

This study has been terminated.
(NIAID terminated the study due to low subject enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570192
First Posted: April 4, 2012
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
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).

Condition Intervention Phase
Bacterial Pneumonia Drug: IV meropenem Drug: I.V. 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 Vancomcin (per institutional guidelines) will be available for MRSA coverage. Device: tobramycin nebulization Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
This is an open-label study with 1:1 randomization between two active treatment groups.
Primary Purpose: Treatment
Official Title: Impact of Aggressive Empiric Antibiotic Therapy and Duration of Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Hospitalized Subjects With Pneumonia Requiring Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Number of Participants With Suppression and Emergence of Resistance [ Time Frame: up to 28 days after enrollment ]
    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.


Secondary Outcome Measures:
  • Efficacy(Clinical Outcome) and Safety (Numbers of SAEs) of PD Optimized/Combination Therapy (Group 1) of Meropenem (2g Infused Over 3 Hours Q8h) Plus Aminoglycoside Parenterally [ Time Frame: Test-of-Cure Visit (TOC, 7-14 days post therapy) and Late-Follow-Up (LFU 14 days after test of cure or up to 42 ± 3 days after study drug initiation) ]
    The efficacy and safety of PD optimized/combination therapy (Group 1) of meropenem (2g infused over 3 hours Q8h) plus aminoglycoside parenterally (tobramycin/or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kgIV Q 24h) plus tobramycin nebulization in the treatment of hospitalized subjects with pneumonia requiring mechanical ventilation caused by P. aeruginosa, Acinetobacter spp, (or other Gram-negative pathogens) when compared to the Group 2 (control arm) of monotherapy meropenem

  • A Pharmacodynamic Relationship Between Meropenem Exposure in Plasma and Extracellular Lung Fluid (ELF) [ Time Frame: Patients will participate up to 45 days ]
  • 28 Day All-cause Mortality Between the Treatment Groups. [ Time Frame: Late-Follow-Up (LFU, 30 (±2) days Post Therapy) ]
  • Microbiological Response at EOT, TOC and LFU Between Treatment Groups. [ Time Frame: End-of-Treatment (EOT last day of study drug, up to 14 days) Test-of-Cure Test-of-Cure Visit (TOC, 7-14 days post therapy)and Late-Follow-Up (LFU - 14 days after TOC or up to 42 ± 3 days after study drug initiation ]
  • Rates of Pathogen Response to Those Seen in the Control Arm. [ Time Frame: End-of-Treatment (EOT last day of study drug, up to 14 days) Test-of-Cure Test-of-Cure Visit (TOC, 7-14 days post therapy)and Late-Follow-Up (LFU - 14 days after TOC or up to 42 ± 3 days after study drug initiation ]
  • Rates of Resistance of Other Gram-negative Bacteria (Non-Pseudomonas or Acinetobacter Spp) Between Treatment Groups. [ Time Frame: End-of-Treatment (EOT last day of study drug, up to 14 days) Test-of-Cure Test-of-Cure Visit (TOC, 7-14 days post therapy)and Late-Follow-Up (LFU - 14 days after TOC or up to 42 ± 3 days after study drug initiation ]
  • The Proportion of Subjects Whose Repeat Cultures Are Negative (e.g. Rates of Clearance of Bacterial Infection) at Day 5 Between Treatment Groups and Among Fermentor and Non-fermentor Pathogens. [ Time Frame: Day 5/EE ]
  • Clinical Outcome in Proportion of Subjects Who Received Prior Antibiotics vs. Those With no Prior Antibiotics [ Time Frame: End-of-Treatment (EOT last day of study drug, up to 14 days) Test-of-Cure Test-of-Cure Visit (TOC, 7-14 days post therapy)and Late-Follow-Up (LFU - 14 days after TOC or up to 42 ± 3 days after study drug initiation ]
  • Health Care Resource Utilization (Length of ICU Stay, Antibiotic Usage, Length of Hospitalization, and Duration of Ventilation) Between Treatment Groups. [ Time Frame: End-of-Treatment (EOT last day of study drug, up to 14 days) Test-of-Cure Test-of-Cure Visit (TOC, 7-14 days post therapy)and Late-Follow-Up (LFU - 14 days after TOC or up to 42 ± 3 days after study drug initiation ]

Enrollment: 43
Study Start Date: September 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV meropenem; parenteral aminoglycoside

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
Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
Other Name: Merrem I.V.
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
a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
Drug: Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.
Device: tobramycin nebulization
tobramycin nebulization 600mg/day
Active Comparator: I.V. Meropenem

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

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

Other Name: Merrem I.V.
Drug: Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.
Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.

Detailed Description:
The goal of this clinical study is to demonstrate that the application of pharmacodynamic dosing principles to the antibiotic treatment of hospitalized subjects with culture-documented pneumonia (including HABP, VABP and HCAP) requiring mechanical ventilation can inhibit the emergence of antibiotic-resistant organisms during treatment and therefore may improve the rate of a satisfactory clinical response. Antibiotic resistance is defined as an increase in meropenem or aminoglycoside MIC by two tube dilutions (fourfold) from baseline. In animal models of infection, the pharmacodynamic driver for bactericidal effect by β lactam antibiotics such as meropenem is the proportion of the dosing interval during which plasma drug levels are maintained above the MIC of the causative pathogen. The hypothesis of this study is that prolongation of time above MIC by increasing total meropenem dose and the duration of infusion will counter-select for the emergence of antimicrobial resistance during the treatment of hospitalized subjects with pneumonia (i.e. HABP, VABP and HCAP) caused by P.aeruginosa, Acinetobacter species (spp), or other pathogens with intermediate susceptibility to meropenem, and that the addition of parenteral aminoglycosides (amikacin, tobramycin or gentamicin) and nebulized aminoglycoside (tobramycin) given along optimal pharmacodynamic principles will further reduce the likelihood of resistance emergence, particularly among the non-fermenting Gram-negative bacilli, such as Pseudomonas aeruginosa and Acinetobacter spp. The observed incidence of resistance emergence to meropenem will be compared across therapeutic regimens.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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.

Exclusion Criteria:

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.

Subjects with profound hypoxia as defined by a PaO2/FiO2 ratio <100.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570192


Locations
United States, California
InClin, Inc.
San Mateo, California, United States, 94403
United States, Florida
UFL Department of Medicine: Pulmonary, Critical Care and Sleep Medicine
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322-4250
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
JMI Laboratories
North Liberty, Iowa, United States, 52317
United States, Missouri
Washington University in St. Louis School of Medicine
St. Louis, Missouri, United States, 63130
United States, New York
Weill Cornell Medical Center of Cornell University
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States, 44195
France
Institut de Cardiologie, Groupe Hospitalier Pitie-Salpetriere
Paris, France, Cedex 13
Germany
Hannover Clinical Trial Center GmbH
Hannover, Germany, 30625
Spain
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: George L Drusano, MD University of Florida
  More Information

Publications:
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Bauernfeind A, Jungwirth R. In Vitro Activity of SM 7338 and Imipenem. 28th ICAAC, Los Angeles, October 1988. Abstract 599
Calandra GB, Hesney M, Brown KR. Imipenem/cilastatin therapy of serious infections: a U.S. multicenter noncomparative trial. Clin Ther. 1985;7(2):225-38.
Clarke AM, Zemcov SJV. SM 7338 (ICI 194,660), A New DHP-1 Stable Carbapenem; In Vitro Activity Against a Wide Range of Canadian Clinical Isolates. 28th ICAAC, Los Angeles, October 1988. Abstract 598.
Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis. 1998 Jan;26(1):1-10; quiz 11-2. Review.
Craig WA. The pharmacology of meropenem, a new carbapenem antibiotic. Clin Infect Dis. 1997 Feb;24 Suppl 2:S266-75. Review.
Dandekar PK, Maglio D, Sutherland CA, Nightingale CH, Nicolau DP. Pharmacokinetics of meropenem 0.5 and 2 g every 8 hours as a 3-hour infusion. Pharmacotherapy. 2003 Aug;23(8):988-91.
Data on file. Drug Development Department, AstraZeneca Pharmaceuticals, Wilmington,DE 19897.
Drusano GL. Prevention of resistance: a goal for dose selection for antimicrobial agents. Clin Infect Dis. 2003 Jan 15;36(Suppl 1):S42-50.
Drusano GL, Liu W, Fregeau C, Kulawy R, Louie A. Differing effects of combination chemotherapy with meropenem and tobramycin on cell kill and suppression of resistance of wild-type Pseudomonas aeruginosa PAO1 and its isogenic MexAB efflux pump-overexpressed mutant. Antimicrob Agents Chemother. 2009 Jun;53(6):2266-73. doi: 10.1128/AAC.01680-08. Epub 2009 Mar 16.
Edwards JR, Wannop C. SM 7338, A New Carbapenem Antibacterial: In Vitro Activity Against Imipenem-Resistant Ps. aeruginosa. 27th ICAAC, New York October 1987, Abstract 754.
Edwards JR, Turner PJ, Withnell ES, et al. SM 7338, A New Carbapenem Antibacterial: In Vitro Activity Against Bacterial Strains of Clinical Origins. 27th ICAAC, New York, October 1987, Abstract 755.
Edwards JR, Turner PJ, Wannop C, Withnell ES, Grindey AJ, Nairn K. In vitro antibacterial activity of SM-7338, a carbapenem antibiotic with stability to dehydropeptidase I. Antimicrob Agents Chemother. 1989 Feb;33(2):215-22.
Fagon JY, Chastre J, Novara A, Medioni P, Gibert C. Characterization of intensive care unit patients using a model based on the presence or absence of organ dysfunctions and/or infection: the ODIN model. Intensive Care Med. 1993;19(3):137-44.
Fink MP, Snydman DR, Niederman MS, Leeper KV Jr, Johnson RH, Heard SO, Wunderink RG, Caldwell JW, Schentag JJ, Siami GA, et al. Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group. Antimicrob Agents Chemother. 1994 Mar;38(3):547-57.
Fukasawa M, Sumita Y, Tada E, et al. SM 7338, A New Carbapenem Antibacterial: In Vitro Activity Against 1607 Clinical Strains of Gram-Positive and Gram-Negative Pathogens. 27th ICAAC, New York, October 1987, Abstract 753.
Fukasawa M, Tada E, Nouda H, et al. Induction and Inhibition of b-Lactamases by SM 7338; A Novel Carbapenem Antibacterial. 28th ICAAC, Los Angeles, October 1988. Abstract 606.
Hamacher J, Vogel F, Lichey J, Kohl FV, Diwok K, Wendel H, Lode H. Treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease in hospitalised patients--a comparison of meropenem and imipenem/cilastatin. COPD Study Group. J Antimicrob Chemother. 1995 Jul;36 Suppl A:121-33.
Heyland DK, Cook DJ, Griffith L, Keenan SP, Brun-Buisson C. The attributable morbidity and mortality of ventilator-associated pneumonia in the critically ill patient. The Canadian Critical Trials Group. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1249-56.
Investigational Brochure, Drug Development Department, AstraZeneca Pharmaceuticals, Wilmington, Delaware 19897.
Jones RN, Barry AL, et al. Antimicrobial Activity of SM 7338, A New DHP-1 Stable Carbapenem. 28th ICAAC, Los Angeles, October 1988. Abstract 597.
Kayser FH, Morenzoni G. Activity of SM 7338, A New Carbapenem Antibacterial Against Gram-Positive Bacteria. 28th ICAAC, Los Angeles, October 1988. Abstract 603.
Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999 Feb;115(2):462-74.
Kollef MH, Silver P, Murphy DM, Trovillion E. The effect of late-onset ventilator-associated pneumonia in determining patient mortality. Chest. 1995 Dec;108(6):1655-62.
Lancero MG, Young LS. In Vitro Studies with SM 7338; A Novel Carbapenem with Broad Bactericidal Activity. 28th ICAAC, Los Angeles, October 1988. Abstract 602.
Lode H, Hamacher J, Eller J, Schaberg T. Changing role of carbapenems in the treatment of lower respiratory tract infections. Scand J Infect Dis Suppl. 1995;96:17-23. Review.
Luna CM, Vujacich P, Niederman MS, Vay C, Gherardi C, Matera J, Jolly EC. Impact of BAL data on the therapy and outcome of ventilator-associated pneumonia. Chest. 1997 Mar;111(3):676-85.
McEachern R, Campbell GD Jr. Hospital-acquired pneumonia: epidemiology, etiology, and treatment. Infect Dis Clin North Am. 1998 Sep;12(3):761-79, x. Review.
Meduri GU, Chastre J. The standardization of bronchoscopic techniques for ventilator-associated pneumonia. Chest. 1992 Nov;102(5 Suppl 1):557S-564S. Review.
Moellering RC Jr, Eliopoulos GM, Sentochnik DE. The carbapenems: new broad spectrum beta-lactam antibiotics. J Antimicrob Chemother. 1989 Sep;24 Suppl A:1-7. Review.
Neu HG, Saha G, Chin NX. In Vitro Activity of SM 7338; A New Carbapenem, Compared with Other Antibacterials Against Multiply Resistant Bacteria. 28th ICAAC, Los Angeles, October 1988. Abstract 601.
Nord CE, Lindmark A, Persson I. Susceptibility of Anaerobic Bacteria to SM 7338. 28th ICAAC, Los Angeles, October 1988. Abstract 596.
Okuda T, Fukasawa M, Tanio T, et al. SM 7338, A New Carbapenem Antibacterial: In Vitro and In Vivo Antibacterial Activities. 27th ICAAC, New York, October 1987. Abstract 757.
Quinn JP, Studemeister AE, DiVincenzo CA, Lerner SA. Resistance to imipenem in Pseudomonas aeruginosa: clinical experience and biochemical mechanisms. Rev Infect Dis. 1988 Jul-Aug;10(4):892-8. Review.
Sanford Guide to Antimicrobial Therapy. Thirty-third Edition, 2003. Gilbert DN, Moellering RC, Sande MA.
Scheld WM, Mandell GL. Nosocomial pneumonia: pathogenesis and recent advances in diagnosis and therapy. Rev Infect Dis. 1991 Jul-Aug;13 Suppl 9:S743-51. Review.
Slaney L, Chubb H, Mohammed Z, et al. In Vitro Activity of SM 7338 Against Neisseria gonorrhoeae (Gc), Haemophilus ducreyi (Hd) and Haemophilus influenzae. 28th ICAAC, Los Angeles, October 1988. Abstract 604.
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Sumita Y, Inoue M, Mitsuhashi S. In Vitro Antibacterial Activity of SM 7338. 28th ICAAC, Los Angeles, October 1988. Abstract 600.
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Torres A, Bauer TT, León-Gil C, Castillo F, Alvarez-Lerma F, Martínez-Pellús A, Leal-Noval SR, Nadal P, Palomar M, Blanquer J, Ros F. Treatment of severe nosocomial pneumonia: a prospective randomised comparison of intravenous ciprofloxacin with imipenem/cilastatin. Thorax. 2000 Dec;55(12):1033-9.
Trouillet JL, Chastre J, Vuagnat A, Joly-Guillou ML, Combaux D, Dombret MC, Gibert C. Ventilator-associated pneumonia caused by potentially drug-resistant bacteria. Am J Respir Crit Care Med. 1998 Feb;157(2):531-9.
Vetter N. The Use of Meropenem ('Merrem'/'Meronen') in the Therapy of Hospital-acquired Lower Respiratory Infections: a Review of Clinical Experience. 18th International Congress of Chemotherapy, Stockholm, Sweden, 27 June-2 July, 1993. Abstract 70.
Wise R, Andrews JM, Ashby JP. The Bactericidal Activity of the Carbapenem, SM 7338, Alone and in Combination. 28th ICAAC, Los Angeles, October 1988. Abstract 605.
World Health Organization. Draft Global Strategy for the Containment of Antimicrobial Resistance. Available on the Internet at http://www.who.int/emc/amr.htm

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01570192     History of Changes
Other Study ID Numbers: 10-0060
First Submitted: March 22, 2012
First Posted: April 4, 2012
Results First Submitted: December 22, 2016
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Florida:
gram negative pathogens
Pseudomonas aeruginosa
Acinetobacter
HCAP
VABP
HABP

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Linezolid
Gentamicins
Tobramycin
Meropenem
Thienamycins
Amikacin
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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