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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Decolonization group

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.

Group Type EXPERIMENTAL

decolonization

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No