Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients

Not Applicable

Withdrawn

• Conditions: Cystic Fibrosis
• Interventions: Drug: decolonization

• Registration Number: NCT01229553
• Lead Sponsor: State University of New York - Upstate Medical University

Brief Summary

The primary objective of this study is to measure efficacy of our new protocol by monitoring the results of our routine respiratory cultures at the end of the new standard treatment, and during routine visits for 1 year from initiation of therapy for Staphylococcus aureus. The secondary objective will include determining the clinical course (pulmonary exacerbations, antibiotic use, hospitalizations, pulmonary function tests) of patients who underwent the protocol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Study Start: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Eligible participants will include all patients with CF who test positive for SA from respiratory tract culture (throat, nares or expectorated sputum) and are 2-23 months of age at protocol presentation.

Exclusion Criteria

Patients co-infected with other bacteria (e.g. Pseudomonas) or documented to have an allergy or resistance to any of the intervention substances will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decolonization group	decolonization	The decolonization protocol for the patients will consist of two-week course of cephalexin (100 mg/kg/day divided TID) or oral T/S (20 mg/kg/day divided BID), HBW every other day for 2 weeks, and mupirocin ointment into both nares BID for 2 weeks.

Primary Outcome Measures

Name	Time	Method
To measure the efficacy of a decolonization regimen to eliminate SA from nares, oropharynx and sputum of pediatric CF patients (2-23 months of age).	1 year

Secondary Outcome Measures

Name	Time	Method
To measure adverse effects of the decolonization regimen (e.g. local irritation, skin dryness, rashes, vomiting, diarrhea) and its impact on carriage with other organisms (e.g., Pseudomonas).	1 year
To evaluate the effect of decolonization regimen on lung changes and/or frequency of pulmonary exacerbations.	1 year
To evaluate adherence to the decolonization regimen	1 year

Trial Locations

Locations (1)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States