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Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 for Nasal Decolonisation of Staphylococcus Aureus

NCT05889351 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-06-05

No results posted yet for this study

Summary

A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the efficacy, safety and tolerability of two dosing regimens with LTX-109 administered topically to the anterior nares in subjects with persistent carriage of Staphylococcus aureus (S. aureus).

Conditions

  • Nasal Decolonization of Staphylococcus Aureus

Interventions

DRUG

Vehicle gel, 4 + 4 applications or 4 + 2 applications

Control arm/placebo

DRUG

LTX-109 3% gel, 4 + 4 applications

Cohort 1 active treatment

DRUG

LTX-109 3% gel, 4 + 2 applications

Cohort 2 active treatment

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Pharma Holdings AS

    lead INDUSTRY

Principal Investigators

  • Johan Nilsson, MD, Phd · ClinSmart AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2022-10-28
Completion
2022-10-28

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05889351 on ClinicalTrials.gov