NCT03817580

Comparative Study of Antimicrobial Effectiveness

Completed Phase 3 Results posted Last updated 22 October 2021

What this trial tests

Phase 3 trial testing Project X 26ml in Bacterial Microflora Reduction in 170 participants. Completed in 4 June 2019.

Timeline

18 February 2019

Primary endpoint
4 June 2019

4 June 2019

Quick facts

Lead sponsor	Professional Disposables International, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	170
Start date	18 February 2019
Primary completion	4 June 2019
Estimated completion	4 June 2019
Sites	1 location across Romania

Drugs / interventions tested

• Project X 26ml — full drug profile →
• Project X 5.1ml — full drug profile →
• Prevantics Maxi Swabstick — full drug profile →

Conditions studied

• Bacterial Microflora Reduction — all drugs for Bacterial Microflora Reduction →

Sponsor

Professional Disposables International, Inc. — full company profile →

Who can join

18 and older, any sex, with Bacterial Microflora Reduction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Bacterial Microflora on the Inguinal Area Primary · 30 seconds

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Group	Value	95% CI
Project X 26ml	-3.92	± 1.42
Project X 5.1ml	-3.69	± 1.56
Prevantics Maxi Swabstick	-3.94	± 1.60

Change in Bacterial Microflora on the Inguinal Area Primary · 10 minutes

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Group	Value	95% CI
Project X 26ml	-4.07	± 1.62
Project X 5.1ml	-4.04	± 1.61
Prevantics Maxi Swabstick	-4.17	± 1.57

Change in Bacterial Microflora on the Inguinal Area Primary · 6 hours

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Group	Value	95% CI
Project X 26ml	-4.30	± 1.43
Project X 5.1ml	-4.57	± 1.62
Prevantics Maxi Swabstick	-4.28	± 1.53

Change in Bacterial Microflora on the Abdomen Primary · 30 seconds

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Group	Value	95% CI
Project X 26ml	-3.09	± 0.76
Project X 5.1ml	-2.95	± 1.11
Prevantics Maxi Swabstick	-2.85	± 1.08

Change in Bacterial Microflora on the Abdomen Primary · 10 minutes

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Group	Value	95% CI
Project X 26ml	-3.15	± 0.85
Project X 5.1ml	-2.97	± 1.06
Prevantics Maxi Swabstick	-3.01	± 0.82

Change in Bacterial Microflora on the Abdomen Primary · 6 hours

Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

Group	Value	95% CI
Project X 26ml	-3.19	± 0.87
Project X 5.1ml	-3.27	± 0.95
Prevantics Maxi Swabstick	-3.18	± 0.91

Sponsor's own description

Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1ml Project X and Prevantics® Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations, ASTM International, West Conshohocken, PA, 2015,

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.