AzTrials
AzTrials

COVID-19ReaMax2NCT05511129

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

An observational study of COVID-19 and Nosocomial Infection, run by Fondation Hôpital Saint-Joseph at 3 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Nosocomial Infection
How many people
1,053 participants
Where
3 sitesFrance
Study dates
12 May 2022to 30 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

  • Centre Hospitalier Bicetre

    Paris

  • Hôpital Cochin

    Paris

Other trials in France

About this study

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.

Read more

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.

Medical subject headings
COVID-19, Cross Infection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 3

Secondary outcomes (3)

  1. 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.

    Measured: Month 3

  2. 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.

    Measured: Month 3

  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.

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start12 May 2022
  3. Primary completion12 Jun 2022
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05511129
Sponsor's protocol ID
ReaMax2
Acronym
ReaMax2
Status last verified
Aug 2022
First submitted
19 Aug 2022
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PubMed 26903338

  • Prescott HC, Angus DC. Enhancing Recovery From Sepsis: A Review. JAMA. 2018 Jan 2;319(1):62-75. doi: 10.1001/jama.2017.17687.

    PubMed 29297082

  • Brun-Buisson C, Meshaka P, Pinton P, Vallet B; EPISEPSIS Study Group. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med. 2004 Apr;30(4):580-8. doi: 10.1007/s00134-003-2121-4. Epub 2004 Mar 2.

    PubMed 14997295

  • Pletz MW, Blasi F, Chalmers JD, Dela Cruz CS, Feldman C, Luna CM, Ramirez JA, Shindo Y, Stolz D, Torres A, Webb B, Welte T, Wunderink R, Aliberti S. International Perspective on the New 2019 American Thoracic Society/Infectious Diseases Society of America Community-Acquired Pneumonia Guideline: A Critical Appraisal by a Global Expert Panel. Chest. 2020 Nov;158(5):1912-1918. doi: 10.1016/j.chest.2020.07.089. Epub 2020 Aug 25.

    PubMed 32858009

  • Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. doi: 10.1097/01.CCM.0000217961.75225.E9.

    PubMed 16625125

  • Kumar A. Early antimicrobial therapy in severe sepsis and septic shock. Curr Infect Dis Rep. 2010 Sep;12(5):336-44. doi: 10.1007/s11908-010-0128-x.

    PubMed 21308515

  • Seymour CW, Kahn JM, Martin-Gill C, Callaway CW, Yealy DM, Scales D, Angus DC. Delays From First Medical Contact to Antibiotic Administration for Sepsis. Crit Care Med. 2017 May;45(5):759-765. doi: 10.1097/CCM.0000000000002264.

    PubMed 28234754

  • Whiles BB, Deis AS, Simpson SQ. Increased Time to Initial Antimicrobial Administration Is Associated With Progression to Septic Shock in Severe Sepsis Patients. Crit Care Med. 2017 Apr;45(4):623-629. doi: 10.1097/CCM.0000000000002262.

    PubMed 28169944

  • Skorup P, Maudsdotter L, Lipcsey M, Larsson A, Sjolin J. Mode of bacterial killing affects the inflammatory response and associated organ dysfunctions in a porcine E. coli intensive care sepsis model. Crit Care. 2020 Nov 14;24(1):646. doi: 10.1186/s13054-020-03303-9.

    PubMed 33189146

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Nosocomial Infection, run by Fondation Hôpital Saint-Joseph at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changed risk of renal failure (time frame: Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05511129, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in