An observational study in COVID-19 and Nosocomial Infection, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,053 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Changed risk of renal failure
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.
Time frame: Month 3
Effect of maximum serum concentration of Amikacin on renal function
This outcome corresponds to the percentage of patients with return to normal creatinine and urea values.
Time frame: Month 3
Effect of Amikacin administration on the probability of recovery of renal function
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.
Time frame: Month 3
Effect of Amikacin administration on the rate of recovery of renal function
This outcome corresponds to the percentage of deaths during the resuscitation stay.
Time frame: Month 3
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Fondation Hôpital Saint-Joseph