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

NCT01229553 | Withdrawn

• 1 other identifier: 5975
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Decolonization group

EXPERIMENTAL

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.

Drug: decolonization

Interventions

decolonization 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.

Decolonization group

Eligibility Criteria

• Age: 2 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jana Shaw, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 11, 2015

Record last verified: 2015-05

Locations

US (1)