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Health Care Associated InfectionPhase 3CLEAN-ITNCT05485051

Daily Chlorexidine Bath for Health Care Associated Infection Prevention

A Phase 3 study testing 2% chlorhexidine digluconate solution with surface-active agents and Usual Baths in people with Health Care Associated Infection and Ventilator Associated Pneumonia, run by Hospital do Coracao at 16 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
2% chlorhexidine digluconate solution with surface-active agents and Usual Baths
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15,730 participants
Where
16 sitesBrazil
Study dates
3 Aug 2022to 31 Mar 2024
Phase
Phase 3
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

Who may be able to join

  • All patients ≥ 18 years/old admitted to the participants's ICUs

Who cannot join

  • History of chlorhexidine allergy

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Brazil16 sites

  • Hospital São Lucas

    Aracaju, Sergipe

  • Hospital Universitário de Brasília

    Brasília, Federal District

  • Hospital Geral de Caxias do Sul

    Caxias do Sul, Rio Grande do Sul

  • Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina

    Colatina, Espírito Santo

  • Hospital Nereu Ramos

    Florianópolis, Santa Catarina

  • Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck

    Florianópolis, Santa Catarina

  • Hospital Municipal de Maringá

    Maringá, Paraná

  • Hospital das Clínicas da Universidade Federal de Pernambuco

    Recife, Pernambuco

  • Hospital Naval Marcílio Dias

    Rio de Janeiro

  • Hospital da Bahia

    Salvador, Estado de Bahia

  • Hospital da Cidade

    Salvador, Estado de Bahia

  • Hospital Santa Cruz

    Santa Cruz do Sul, Rio Grande do Sul

  • Hospital Regional do Baixo Amazonas Dr. Waldemar Penna

    Santarém, Pará

  • Hospital Aviccena

    São Paulo, São Paulo

  • AC Camargo Câncer Center

    São Paulo

  • BP-A Beneficiência Portuguesa de São Paulo

    São Paulo

Other trials in Brazil

About this study

Official title: Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial

Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.

Read the detailed description

Healthcare-associated infections (HAI) are common complications in critically ill patients and are associated with increased costs, higher length of stay, and higher morbimortality. Data shows that daily chlorhexidine baths might be associated with lower HAI rates in a broad population of critically ill patients. The purpose of this trial is to evaluate the effect of daily bathing with chlorhexidine compared to usual baths (soap and water) on HAI in critically ill patients.

Being tested
2% chlorhexidine digluconate solution with surface-active agents, Usual Baths
Medical subject headings
Cross Infection, Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2% chlorhexidine digluconate solution with surface-active agentsOther

    Also called Chlorhexidine baths

    Bathing will be performed at least daily using 2% chlorhexidine digluconate solution with surface-active agents on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.

  • Usual BathsOther

    Also called Soap and water baths

    Bathing will be performed at least daily using soap and water (performed according to the current practice in each center) on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.

Study groups in NCT05485051
Study groupRoleWhat they receive
Chlorhexidine bathsExperimentalAll patients in the cluster randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution with surface-active agents during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.
Receives: Other: 2% chlorhexidine digluconate solution with surface-active agents
Usual bathsActive comparatorAll patients in the cluster randomized to the intervention arm will receive baths using soap and water according to the current practice in each center during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.
Receives: Other: Usual Baths

What is being measured

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

  1. Composite of healthcare-associated infections (HAI)

    Composite outcome of the following HAI:

    Ventilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)

    Measured: Within each cluster duration (90 days)

Secondary outcomes (9)

  1. Rates of multi-drug-resistant pathogens

    Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens.

    Measured: Within each cluster duration (90 days)

  2. Ventilator associated pneumonia (VAP)

    Rates of Ventilator associated pneumonia (VAP)

    Measured: Within each cluster duration (90 days)

  3. Central line-associated blood stream infections (CLABSI)

    Rates of Central line-associated blood stream infections (CLABSI)

    Measured: Within each cluster duration (90 days)

  4. Catheter-associated urinary tract infection (CAUTI)

    Rates of Catheter-associated urinary tract infection (CAUTI)

    Measured: Within each cluster duration (90 days)

  5. Hospital length of stay

    Hospital length of stay

    Measured: Until hospital discharge, maximum 90 days

  6. Intensive Care Unit length of stay

    Intensive Care Unit length of stay

    Measured: Until Intensive Care Unit discharge, maximum 90 days

  7. Antibiotic use

    Antibiotic use per unit

    Measured: Within each cluster duration (90 days)

  8. In hospital mortality

    In hospital mortality

    Measured: Maximum 90 days after randomization

  9. Intensive Care Unit mortality

    Intensive Care Unit mortality

    Measured: Maximum 90 days after randomization

Timeline

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

  1. First posted2 Aug 2022
  2. Study start3 Aug 2022
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
The study consists in two intervention (chlorhexidine baths) periods (three months each period) and two control (usual baths) periods (three months each period) for each cluster. The clusters will crossover between intervention and control with one month of washout period between different periods.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
15,730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485051
Sponsor's protocol ID
ip_hcor_cleanit
Acronym
CLEAN-IT
Status last verified
May 2024
First submitted
28 Jul 2022
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Tomazini BM, Besen BAMP, Gales AC, Bianchini L, Lisboa T, Maia IS, Veiga TS, Santos RHN, Santos ES, Tokunaga SM, Barbante LG, Campos VB, Kojima FCS, Miranda TA, Ramos NC, Prestes RM, Lima VP, Freitas P, Vidal CFL, Santiago RCB, Dracoulakis MDA, Romano M, Melo RMV, Pereira FC, Rozetti CMT, Souza RM, Lacerda FH, Berti IR, Irineu V, Figueiredo RC, Magdalena MS, Dantas VC, Arns B, Marssola G, Veiga VC, Pereira AJ, Nassar AP Jr, Cavalcanti AB. Daily Chlorhexidine Bathing for the Prevention of Nosocomial Infections in Critically Ill Patients (CLEAN-IT): a multicentre, cluster-randomised, crossover trial. Lancet Reg Health Am. 2026 Feb 12;56:101400. doi: 10.1016/j.lana.2026.101400. eCollection 2026 Apr.

    PubMed 41732706

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2% chlorhexidine digluconate solution with surface-active agents and Usual Baths in people with Health Care Associated Infection and Ventilator Associated Pneumonia, run by Hospital do Coracao at 16 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: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite of healthcare-associated infections (HAI) (time frame: Within each cluster duration (90 days)). 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 NCT05485051, which also lists 1 linked publication.

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 13 Jun 2024.

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