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| ID | Type | Description | Link |
|---|---|---|---|
| K08AI072043 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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Staphylococcus aureus is a bacteria that causes serious, often life threatening infections including pneumonia, wound, and bloodstream infections. Persons with AIDS are at high risk for S. aureus infections. They are also at high risk for nasal carriage of S. aureus. In fact, nasal carriage is a known risk factor for subsequent S. aureus infection. Topical mupirocin, an antibiotic when applied to the anterior nares, is a safe, effective way to eliminate S. aureus colonization. Some studies have shown that mupirocin can also decrease the risk of S. aureus infection, but many of those studies utilized historical controls and none were rigorously tested among AIDS patients over an extended period of time.
The main purpose of this randomized, double-blinded, placebo controlled study is to determine if mupirocin can eliminate S. aureus nasal colonization in residents at PSI (inpatient, drug rehabilitation facility for AIDS patients in the Bronx.) PSI residents currently have a high incidence of S. aureus nasal colonization and infection. Nasal cultures followed by twice daily application of mupirocin vs. placebo for five days will be performed on a monthly basis for 8 months. the study will examine whether mupirocin decreases the incidence of S. aureus infections and prevents S. aureus nasal colonization. The study is important because it may show that mupirocin is an effective way to eliminate nasal colonization and prevent S. aureus infections in AIDS patients, among those at highest risk for serious S. aureus infection.
Hypothesis: Monthly application of mupirocin will reduce nasal colonization with S.aureus
This was a randomized double-blinded placebo controlled trial. Subjects were treated with intranasal mupirocin or placebo on a monthly basis and tested for nasal colonization a month after each treatment. This was performed up to 8 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mupirocin ointment | Active Comparator | 0.25g mupirocin calcium ointment, 2% in each nostril twice daily for 5 days (repeated monthly for up to 8 months) |
|
| Placebo ointment | Placebo Comparator | 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin calcium ointment, 2% | Drug | 0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal colonization with Staphylococcus aureus | monthly assessment of colonization (~1 month after each treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Infection with Staphylococcus aureus | monthly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel J Gordon, MD, MPH | Columbia University | Study Director |
| Franklin D Lowy, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States | ||
| Project Samaritan Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20686410 | Result | Gordon RJ, Chez N, Jia H, Zeller B, Sobieszczyk M, Brennan C, Hisert KB, Lee MH, Vavagiakis P, Lowy FD. The NOSE study (nasal ointment for Staphylococcus aureus eradication): a randomized controlled trial of monthly mupirocin in HIV-infected individuals. J Acquir Immune Defic Syndr. 2010 Dec;55(4):466-72. doi: 10.1097/QAI.0b013e3181ec2a68. |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D015658 | HIV Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D000086982 | Blood-Borne Infections |
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| Placebo ointment | Drug | Placebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months) |
|
| The Bronx |
| New York |
| 10452 |
| United States |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |