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Tolerance and Efficacy of Amiklin Administration During Nosocomial Infections Complicating COVID-19 in the ICU (ReaMax2)

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: NCT05511129
Recruitment Status : Active, not recruiting
First Posted : August 22, 2022
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

The most severe infectious episodes are managed in intensive care. Classically, a distinction is made between sepsis, an infection associated with an inappropriate, excessive response of the immune system, responsible for organ dysfunction, and septic shock, during which, within the potential dysfunctions, hemodynamic alteration is central, requiring the introduction of catecholamines. The seriousness of these disorders, particularly because of their potential short-term severity, requires immediate treatment. The treatment of severe infections is based on the control of microbial proliferation, particularly bacterial. In this context, the speed of antibiotic therapy is associated with patient prognosis. If the administration of antibiotic therapy is an emergency during severe infections, particularly in situations of septic shock, its choice is decisive in the effectiveness of management and in the prognosis of the patient. Prior to microbiological results, antibacterial treatment is probabilistic. In spite of these numerous parameters, failure of probabilistic antibiotic therapy, due to a spectrum unsuited to the pathogens, is described in 15 to 30% of cases. In order to limit the risk of inappropriate treatment, it is recommended that broad-spectrum antibiotic therapy be used in states of shock of infectious origin. Because of their bactericidal properties, their kinetics of effectiveness, their marked post-antibiotic effect, their bioavailability in the plasma sector, and their synergy with beta-lactams, aminoglycosides are often recommended in combination in the initial probabilistic treatment. Despite numerous studies and extensive international experience with aminoglycosides, their real value in the management of severe infections remains uncertain, leading to contradictory information depending on whether one is interested in their benefit in the treatment of identified infections or in the probabilistic treatment of severe conditions.

During the management of severe intensive care patients, the pharmacokinetics of drugs, especially antibiotics, are considerably modified. As a result, monitoring of plasma, or better, tissue concentrations of antibiotics is suggested by learned societies, although their practical realization is still very limited by numerous obstacles.

Misuse of aminoglycosides is associated with a risk of acute renal failure, centered on the tubular toxicity of the antibiotic. While the risks associated with inappropriate frequency of administration are currently modest, those associated with high peak concentration, responsible for an increase in the duration of renal exposure, are not well known.

COVID-19 is also associated with a high risk of impaired renal function. The effect of aminoglycoside administration in the context of COVID-19 remains unknown. Our goal is to determine whether the presence of COVID-19 associates with an elevated risk of renal failure when prescribing aminoglycoside.


Condition or disease
COVID-19 Nosocomial Infection

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Study Type : Observational
Actual Enrollment : 1053 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Tolerance and Efficacy of Amiklin Administration During Nosocomial Infections Complicating COVID-19 in the ICU
Actual Study Start Date : May 12, 2022
Actual Primary Completion Date : June 12, 2022
Estimated Study Completion Date : June 30, 2023





Primary Outcome Measures :
  1. Changed risk of renal failure [ Time Frame: Month 3 ]
    This outcome corresponds to the evolution of renal function, calculated as the difference 1/ between the creatinine and urea values at entry and the maximum value and 2/ between the creatinine and urea values at entry and the value at discharge.


Secondary Outcome Measures :
  1. Effect of maximum serum concentration of Amikacin on renal function [ Time Frame: Month 3 ]
    This outcome corresponds to the percentage of patients with return to normal creatinine and urea values.

  2. Effect of Amikacin administration on the probability of recovery of renal function [ Time Frame: Month 3 ]
    This outcome corresponds to the number of days between the maximum creatinine and urea value and normalization of the values. A "normal" value at discharge is defined as a value less than 1.25 times the entry value.

  3. Effect of Amikacin administration on the rate of recovery of renal function [ Time Frame: Month 3 ]
    This outcome corresponds to the percentage of deaths during the resuscitation stay.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with age ≥ 18 years, hospitalized for respiratory Covid-19 in the ICU or Respiratory Department for a PCR-confirmed respiratory infection with COVID-19
Criteria

Inclusion Criteria:

  • Patient with age ≥ 18 years
  • Hospitalization for respiratory Covid-19
  • Patient hospitalized in the ICU or Respiratory Department for a PCR-confirmed respiratory infection with COVID-19
  • French-speaking patient

Exclusion Criteria:

  • Patient with a severe psychiatric disorder
  • A dying patient
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his or her data for this research

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): NCT05511129


Locations
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France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Centre Hospitalier Bicetre
Paris, France
Hôpital Cochin
Paris, France
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: François PHILIPPART, MD Groupe Hospitalier Paris Saint Joseph
Publications:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT05511129    
Other Study ID Numbers: ReaMax2
First Posted: August 22, 2022    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Cross Infection
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Iatrogenic Disease