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Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF

NCT04553419 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-01-14

No results posted yet for this study

Summary

This is a randomized, double-blinded study that aims to assess the effect of an oral antibiotic called Cephalexin (150 mg/kg/day) compared to placebo in clinically stable children with cystic fibrosis who have grown a bacteria called MSSA (methicillin-susceptible Staphylococcus aureus) over the course of 2 weeks.

A sensitive technique called MBW (multiple breath washout) will be used to look at how well the participants lungs are functioning during the study and to see if the antibiotic improves function. The primary outcome of the study will be the relative change in the MBW measurement (LCI2.5) between day 0 and day 14 of study treatment.

Conditions

Interventions

DRUG

Cephalexin

Cephalexin capsule: TEVA Cephalexin Cephalexin suspension: LUPIN Cephalexin

DRUG

Placebo

Cellulose capsules or suspension

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Jonathan Rayment, MDCM · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04553419 on ClinicalTrials.gov