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Clinical Trials to Reduce the Risk of Antimicrobial Resistance

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.
ClinicalTrials.gov Identifier: NCT01570192
Recruitment Status : Terminated (NIAID terminated the study due to low subject enrollment)
First Posted : April 4, 2012
Results First Posted : April 20, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bacterial Pneumonia
Interventions 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 Vancomycin (per institutional guidelines) will be available for MRSA coverage.
Device: tobramycin nebulization
Enrollment 43
Recruitment Details We had 8 clinical sites: recruitment into the study began September 2010 and ended April 10, 2015.
Pre-assignment Details Enrolled participants were excluded from the trial before assignment to groups because participants had no qualifying organisms; this includes participants with no growth on screening BAL, those with < 104 CFU/mL on BAL, and those with only Gram-positive bacteria cultured from the BAL.
Arm/Group Title IV Meropenem; Parenteral Aminoglycoside I.V. Meropenem
Hide Arm/Group Description

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.

IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).

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)

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

tobramycin nebulization: tobramycin nebulization 600mg/day

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.

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

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

Period Title: Overall Study
Started 13 30
Completed 6 17
Not Completed 7 13
Reason Not Completed
no qualifying organism             6             12
changed to palliative care             1             0
Physician Decision             0             1
Arm/Group Title IV Meropenem; Parenteral Aminoglycoside I.V. Meropenem Total
Hide Arm/Group Description

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.

IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).

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)

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

tobramycin nebulization: tobramycin nebulization 600mg/day

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.

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

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

Total of all reporting groups
Overall Number of Baseline Participants 13 30 43
Hide Baseline Analysis Population Description
Number of patients enrolled in the study and who had a baseline BAL.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 30 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  46.2%
20
  66.7%
26
  60.5%
>=65 years
7
  53.8%
10
  33.3%
17
  39.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 30 participants 43 participants
61.2  (18.3) 58.4  (12.6) 59.2  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 30 participants 43 participants
Female
7
  53.8%
13
  43.3%
20
  46.5%
Male
6
  46.2%
17
  56.7%
23
  53.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 30 participants 43 participants
United States 11 18 29
France 2 11 13
Spain 0 1 1
Baseline acute physiology and chronic health evaluation II (APACHE II) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 13 participants 30 participants 43 participants
22.6  (4.6) 21.0  (6.2) 21.5  (5.8)
[1]
Measure Description: A severity of disease classification system applied within 24 hours of patient admission to an ICU. The point score is calculated from a patient's age and physiological measurements. The range of score is between 0-71. Physiological measurements and all ages fit into that range. Note: the higher the score, the higher the probability of death.
1.Primary Outcome
Title Number of Participants With Suppression and Emergence of Resistance
Hide Description 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.
Time Frame up to 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in the ME population with BAL at baseline and at Day 5/EE and pathogens collected at baseline BAL and at Day 5/EE BAL.
Arm/Group Title IV Meropenem; Parenteral Aminoglycoside I.V. Meropenem
Hide Arm/Group Description:

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.

IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).

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)

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

tobramycin nebulization: tobramycin nebulization 600mg/day

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.

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

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

Overall Number of Participants Analyzed 0 6
Measure Type: Number
Unit of Measure: participants
suppression of emergence of resistance 5
emergence of resistance 1
2.Secondary Outcome
Title Clinical Response
Hide Description Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)
Time Frame End of treatment - up to 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.
Arm/Group Title ME Group - Meropenem Plus Aminoglycoside MEGroup - Meropenem Only m-MITT Group - Meropenem Plus Aminoglycoside m-MITT Group - Meropenem Only
Hide Arm/Group Description:
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Overall Number of Participants Analyzed 4 15 6 18
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
8
  53.3%
2
  33.3%
8
  44.4%
3.Secondary Outcome
Title Clinical Response in Subjects Who Received Prior Antibiotics
Hide Description Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)
Time Frame End of treatment - up to 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.
Arm/Group Title ME Group - Meropenem Plus Aminoglycoside ME Group - Meropenem Only m-MITT Group - Meropenem Plus Aminoglycoside m-MITT Group - Meropenem Only
Hide Arm/Group Description:
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Overall Number of Participants Analyzed 3 5 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  33.3%
2
  40.0%
1
  25.0%
2
  33.3%
4.Secondary Outcome
Title Overall Microbiologic Response
Hide Description Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)
Time Frame End of treatment - up to 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.
Arm/Group Title ME Group - Meropenem Plus Aminoglycoside ME Group - Meropenem Only m-MITT Group - Meropenem Plus Aminoglycoside m-MITT Group - Meropenem Only
Hide Arm/Group Description:
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Overall Number of Participants Analyzed 4 15 6 18
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
6
  40.0%
2
  33.3%
7
  38.9%
5.Secondary Outcome
Title Pretreatment Pathogen Response
Hide Description Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)
Time Frame End of treatment - up to 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.
Arm/Group Title ME Group - Meropenem Plus Aminoglycoside ME Group - Meropenem Only m-MITT Group - Meropenem Plus Aminoglycoside m-MITT Group - Meropenem Only
Hide Arm/Group Description:
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Overall Number of Participants Analyzed 4 15 6 18
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
9
  60.0%
3
  50.0%
11
  61.1%
6.Secondary Outcome
Title Suppression of the Emergence of Resistance in Other Gram-negative Pathogens
Hide Description Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)
Time Frame Day 5/Early Extubation
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.
Arm/Group Title ME Group - Meropenem Plus Aminoglycoside ME Group - Meropenem Only m-MITT Group - Meropenem Plus Aminoglycoside m-MITT Group - Meropenem Only
Hide Arm/Group Description:
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Overall Number of Participants Analyzed 1 1 1 2
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
1
 100.0%
1
 100.0%
2
 100.0%
7.Secondary Outcome
Title Occurrence of Repeat Negative Cultures
Hide Description Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)
Time Frame Day 5/Early Extubation
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.
Arm/Group Title ME Group - Meropenem Plus Aminoglycoside ME Group - Meropenem Only m-MITT Group - Meropenem Plus Aminoglycoside m-MITT Group - Meropenem Only
Hide Arm/Group Description:
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Overall Number of Participants Analyzed 4 15 4 17
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
6
  40.0%
3
  75.0%
7
  41.2%
8.Secondary Outcome
Title Mortality
Hide Description Percentage of patients who died by efficacy endpoint, treatment group and population (n/N)
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.
Arm/Group Title ME Group - Meropenem Plus Aminoglycoside ME Group - Meropenem Only m-MITT Group - Meropenem Plus Aminoglycoside m-MITT Group - Meropenem Only
Hide Arm/Group Description:
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Overall Number of Participants Analyzed 4 15 6 18
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
0
   0.0%
2
  33.3%
2
  11.1%
9.Secondary Outcome
Title Mortality
Hide Description Percentage of patients who died by efficacy endpoint, treatment group and population (n/N)
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.
Arm/Group Title ME Group - Meropenem Plus Aminoglycoside ME Group - Meropenem Only m-MITT Group - Meropenem Plus Aminoglycoside m-MITT Group - Meropenem Only
Hide Arm/Group Description:
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population
Percentage of patients with successful responses by efficacy endpoint, Microbiologic Evaluable (ME) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Percentage of patients with successful responses by efficacy endpoint, Microbiologically modified ITT (m-MITT) group and population.
Overall Number of Participants Analyzed 4 15 6 18
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
1
   6.7%
3
  50.0%
3
  16.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Meropenem; Parenteral Aminoglycoside I.V. Meropenem
Hide Arm/Group Description

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.

IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).

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)

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

tobramycin nebulization: tobramycin nebulization 600mg/day

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.

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

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

All-Cause Mortality
IV Meropenem; Parenteral Aminoglycoside I.V. Meropenem
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IV Meropenem; Parenteral Aminoglycoside I.V. Meropenem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/13 (46.15%)      11/30 (36.67%)    
Cardiac disorders     
cardiogenic shock   0/13 (0.00%)  0 1/30 (3.33%)  1
cardiac arrest   1/13 (7.69%)  1 1/30 (3.33%)  1
AICD fired/NSTEMI [1]  0/13 (0.00%)  0 1/30 (3.33%)  1
PEA arrest  1/13 (7.69%)  1 0/30 (0.00%)  0
Gastrointestinal disorders     
reinforced duodenal ulcer   1/13 (7.69%)  1 0/30 (0.00%)  0
General disorders     
multi-organ failure  0/13 (0.00%)  0 2/30 (6.67%)  2
multi-organ failure due to distributive and cardiogenic shock  1/13 (7.69%)  1 0/30 (0.00%)  0
stroke [2]  0/13 (0.00%)  0 1/30 (3.33%)  1
pulmonary embolism [3]  0/13 (0.00%)  0 1/30 (3.33%)  1
refractory shock  0/13 (0.00%)  0 1/30 (3.33%)  1
septic shock  0/13 (0.00%)  0 1/30 (3.33%)  1
cardiorespiratory arrest  0/13 (0.00%)  0 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders     
pneomonia   1/13 (7.69%)  1 1/30 (3.33%)  1
COPD with acute exacerbation [1]  0/13 (0.00%)  0 1/30 (3.33%)  1
pneumothorax  1/13 (7.69%)  1 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders     
cutaneous eruption   0/13 (0.00%)  0 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
Note: this patient in group 2 (IV mero only) experienced 2 SAES that occurred in separate organ systems: AICD fired/NSTEMI and COPD with acute exacerbation. Therefore, this patient was counted twice.
[2]
Note: this patient in group 2 (IV mero only) experienced 2 SAES that occurred in separate organ systems: Pulmonary embolism and stroke.. Therefore, this patient was counted twice.
[3]
Note: this patient in group 2 (IV mero only) experienced 2 SAES that occurred in separate organ systems: Pulmonary embolism and stroke. Therefore, this patient was counted twice.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Meropenem; Parenteral Aminoglycoside I.V. Meropenem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/30 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. George L. Drusano
Organization: University of Florida, Department of Medicine
Phone: 407-313-7060
Publications:
Bauernfeind A, Jungwirth R. In Vitro Activity of SM 7338 and Imipenem. 28th ICAAC, Los Angeles, October 1988. Abstract 599
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.
Data on file. Drug Development Department, AstraZeneca Pharmaceuticals, Wilmington,DE 19897.
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.
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.
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.
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.
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.
Sanford Guide to Antimicrobial Therapy. Thirty-third Edition, 2003. Gilbert DN, Moellering RC, Sande MA.
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.
Strasbaugh LJ. Nosocomial repiratory infections. In: Mandell GL, Bennett JE, Dolin R, editors. Principles and practice of infectious disease. Philadelphia: Churchill Livingstone, 2000: 3021-3026.
Sumita Y, Fukasawa M, Okunda T. SM 7338, A New Carbapenem Antibacterial: Affinities for PBP's and Morphological Changes. 27th ICAAC, New York, October 1987. Abstract 756.
Sumita Y, Inoue M, Mitsuhashi S. In Vitro Antibacterial Activity of SM 7338. 28th ICAAC, Los Angeles, October 1988. Abstract 600.
Sunagawa M, Matsumura H, Inoue T, et al. SM 7338, A New Carbapenem Antibacterial: Structure-Activity Relations and Physiochemical Properties. 27th ICAAC, New York, October 1987. Abstract 752.
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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: September 29, 2017