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protocol was never implemented as procedures became standard of care
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jana Shaw, MD | State University of New York - Upstate Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 1 year |
| To evaluate adherence to the decolonization regimen | 1 year |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |