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Central Nervous System InfectionsIMPACTO-SNCNCT06412523

Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil

An observational study of Central Nervous System Infections, run by Beneficência Portuguesa de São Paulo at 18 sites in Brazil.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients. Neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Nervous System Infections
How many people
554 participants
Where
18 sitesBrazil
Study dates
15 Aug 2022to 30 Jun 2024
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
  • Adult, Older adult

Study population: Adults admitted to Intensive Care Units.

Who may be able to join

  • All patients over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt.

Who cannot join

  • Diagnosis of brain death.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Brazil18 sites

  • Hospital de Amor (Fundação PIO XII - Barretos)

    Barretos, São Paulo

  • Santa Casa de Belo Horizonte

    Belo Horizonte, Minas Gerais

  • Hospital Geral Cleriston Andrade

    Feira de Santana, Estado de Bahia

  • Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck

    Florianópolis, Santa Catarina

  • Hospital Unimed Limeira

    Limeira, São Paulo

  • Hospital Universitário Onofre Lopes

    Natal, Rio Grande do Norte

  • Santa Casa de Misericórdia de Passos

    Passos, Minas Gerais

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital das Clínicas - FMUSP Ribeirão Preto

    Ribeirão Preto, São Paulo

  • Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar)

    Rio de Janeiro, Rio de Janeiro

  • Hospital da Cidade

    Salvador, Estado de Bahia

  • Hospital e Maternidade Brasil (Rede D´or São Luis)

    Santo André, São Paulo

  • Santa Casa de Misericórdia de São João del Rei

    São João del Rei, Minas Gerais

  • Beneficência Portuguesa de São Paulo

    São Paulo, São Paulo

  • Hospital do Coração

    São Paulo, São Paulo

  • Hospital São Luiz Itaim

    São Paulo, São Paulo

  • Hospital São Paulo

    São Paulo, São Paulo

  • Unimed Vitória

    Vitória, Espírito Santo

Other trials in Brazil

About this study

Resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients. Neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality. In Brazil, there are several multicenter studies demonstrating the prevalence and types of resistant microorganisms, however, there is a lack of data related to central nervous system infections associated with invasive devices, which can have a direct impact on prevention and treatment policies.

Read the detailed description

Neurosurgical procedures with placement of devices are related to increased morbidity and mortality. A study shows that the incidence of device-related central nervous system infection can reach 27%. A meta-analysis published in 2015, which included 35 studies, showed an incidence of 11.4 per 1000 catheters-day.

This is a prospective cohort study, including adult patients, in the ICUs of hospitals participating in the IMPACTO MR Platform, who have a catheter device for monitoring intracranial pressure or external ventricular shunt, with infection densities and microbiological profile being evaluated; risk factors; clinical management; costs involved and short- and long-term clinical outcomes

Keywords
Central Nervous System Infections, Catheters
Medical subject headings
Central Nervous System Infections

What is being measured

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

  1. Incidence density of central nervous system infection

    Incidence density will be reported as number of CNS infections per 1000 catheters/day, together with 95% CI. Cumulative incidence will also be reported.

    Measured: 30 days after study inclusion

Secondary outcomes (6)

  1. Microbiological characteristics

    Microbiological characteristics of device-related central nervous system infections, considering the prevalence of microorganisms (multi-resistant or not)

    Measured: 30 days after study inclusion

  2. Risk factors

    Risk factors for the development of central nervous system infections in the population studied: institution-associated, operator-associated, patient-associated

    Measured: 30 days after study inclusion

  3. Treatment

    Treatment practices, focusing on: antimicrobials (time and duration) and focus management (device removal versus maintenance)

    Measured: 30 days after study inclusion

  4. Costs

    Costs associated with the duration of infection

    Measured: 30 days after study inclusion

  5. Deaths

    Deaths during hospital stay and long-term (6 months)

    Measured: 30 days and 6 months after study inclusion

  6. Rankin scale

    Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

    The patient is classified as follows:

    • No symptoms at all;
    • No significant disability despite symptoms; able to carry out all usual duties and activities
    • Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    • Moderate disability; requiring some help, but able to walk without assistance
    • Moderately severe disability; unable to walk and attend to bodily needs without assistance
    • Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    • Dead

    Measured: 30 days and 6 months after study inclusion

Timeline

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

  1. First posted14 May 2024
  2. Study start15 Aug 2022
  3. Primary completion1 Dec 2023
  4. Study completion30 Jun 2024 (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
Prospective
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06412523
Sponsor's protocol ID
17558
Acronym
IMPACTO-SNC
Status last verified
May 2024
First submitted
11 Aug 2022
Last updated
14 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Central Nervous System Infections, run by Beneficência Portuguesa de São Paulo at 18 sites in Brazil.

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 1 inclusion and 1 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Brazil. 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?

Incidence density of central nervous system infection (time frame: 30 days after study inclusion). 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 NCT06412523.

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 14 May 2024.

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