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The effectiveness of Antiseptic solution for Prevention of intravenous catheter-related blood stream infection with OLanexidine gLucOnate and chlorhexidine containing dressing -Apollo study 2-

A 2*2 Factorial Design Trial Investigating Catheter-Related Bloodstream Infection Prevention in Patients with Peripherally Inserted Central Catheters: Evaluation of Non-Inferiority of Olanexidine Gluconate Solution Compared to Chlorhexidine Alcohol and Superiority of Chlorhexidine-Containing Dressing Compared to Standard Dressing (Study on the Effectiveness of Olanexidine Gluconate and Chlorhexidine-Containing Dressing in Preventing Peripherally Inserted Central Catheter-Related Bloodstream Infections) - Apollo study 2

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057764
Enrollment
1600
Registered
2026-04-01
Start date
2026-07-01
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 aged 18 years or older who are admitted to acute care hospitals (defined as hospitals with ICU, HCU, or equivalent wards [such as those receiving emergency medical care management fees])

Interventions

1.5% olanexidine gluconate solution (Olanedine):Olanedine solution 1.5% antiseptic applicator 10ml (Otsuka Pharmaceutical Factory, Inc.) + chlorhexidine-containing dressing (CHG dressing)*3M Tegaderm

Sponsors

Jichi Medical University Saitama Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Peripherally Inserted Central Catheter inserted in patients aged 18 years or older who are admitted to acute care hospitals (defined as hospitals with ICU, HCU, or equivalent wards [such as those receiving emergency medical care management fees])

Exclusion criteria

Exclusion criteria: 1. Patients with allergies to antiseptics 2. Cases where consent could not be obtained from the subject or their close relatives 3. Patients with systemic skin diseases 4. Cases with skin ulcers at the wound site 5. Patients using antimicrobial catheters 6. Patients participating in intervention trials related to CRBSI prevention (e.g., dressing formulations, skin antiseptics, antimicrobial catheters, antimicrobial administration, etc.) 7. Cases deemed difficult to obtain consent, such as in emergencies

Design outcomes

Primary

MeasureTime frame
Incidence of catheter-related infections

Secondary

MeasureTime frame
1. Occurrence of catheter-related infections (rate per 1000 catheter-days) 2. CRBSI (Catheter-Related Bloodstream Infection) 3. In-hospital mortality rate 4. ICU/HCU mortality rate 5. Resistant bacteria (MRSA, Pseudomonas aeruginosa, VRE) incidence rate 6. Adverse events (redness, urticaria, anaphylaxis, contact dermatitis, others)

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