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Efficacy of oranexidine gluconate in the prevention of catheter-related bloodstream infections

The effectiveness of Antiseptic solution for Prevention of intravenous catheter-related blood stream infection with OLanexidine glucOnate - Apollo study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042343
Enrollment
1980
Registered
2020-11-05
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients 18 years of age or older admitted to the ICU or HCU with a newly inserted central venous catheter or hemodialysis catheter

Interventions

Intervention: 1.5% Oranexidine gluconate solution (Otsuka Pharmaceutical Factory, Inc.) Control: 1% chlorhexidine alcohol (Toho Yakuhin Co.,Ltd)

Sponsors

Jichi Medical University Saitama Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 18 years of age or older admitted to the ICU or HCU with newly inserted central venous or hemodialysis catheters.

Exclusion criteria

Exclusion criteria: 1) Patients with allergies to disinfectants 2) When the consent of the subject or his or her next of kin cannot be obtained 3) Patients with systemic skin diseases 4) The presence of a wound skin ulcer 5) When the catheter is replaced under the guidewire 6) Patients with antimicrobial catheters 7) Patients with antimicrobial-containing dressings 8) Patients participating in intervention trials related to CRBSI prevention (e.g., dressings, skin disinfectants, antimicrobial catheters, antimicrobial medications, etc.) 9) When it is judged to be difficult to obtain consent due to an emergency, etc.

Design outcomes

Primary

MeasureTime frame
Incidence of catheter-related infections

Secondary

MeasureTime frame
1) Incidence of catheter-related infections (per 1000 catheters/day) 2) In-hospital mortality rate 3) ICU mortality rate 4) Incidence of resistant bacteria (MRSA, Pseudomonas aeruginosa, VRE) 5) Adverse events (redness, urticaria, anaphylaxis, contact dermatitis etc.)

Countries

Japan

Contacts

Public ContactHideto Yasuda

Jichi Medical University Saitama Medical Center Department of Emergency and Critical Care Medicine

yasudahideto@me.com048-647-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026