## Protocol Section
### Identification Module
**NCT ID:** NCT00801879

**Brief Title:** Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection

**Official Title:** Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection

#### Organization Study ID Info
**ID:** AAAB0129
#### Organization
**Class:** OTHER
**Full Name:** Columbia University
#### Secondary ID Infos
**ID:** K08AI072043
**Link:** https://reporter.nih.gov/quickSearch/K08AI072043
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2006-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-10-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-10-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2006-04

**Type:** ACTUAL

#### Start Date
**Date:** 2003-09

**Status Verified Date:** 2014-10

#### Study First Post Date
**Date:** 2008-12-04
**Type:** ESTIMATED
**Study First Submit Date:** 2008-12-03
**Study First Submit QC Date:** 2008-12-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

**Class:** NIH

**Name:** National Institute of Allergy and Infectious Diseases (NIAID)

#### Lead Sponsor

**Class:** OTHER

**Name:** Columbia University

#### Responsible Party

**Investigator Affiliation:** Columbia University

**Investigator Full Name:** Franklin D. Lowy

**Investigator Title:** Professor of Medicine and Pathology at the New York-Presbyterian Hospital at the Columbia University Medical Center

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Staphylococcus Aureus

- HIV Infections

**Keywords:**

- mupirocin

- Staphylococcus aureus

- colonization

- infection

- HIV

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 0.25g mupirocin calcium ointment, 2% in each nostril twice daily for 5 days (repeated monthly for up to 8 months)

**Intervention Names:**

- Drug: Mupirocin calcium ointment, 2%

**Label:** Mupirocin ointment

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)

**Intervention Names:**

- Drug: Placebo ointment

**Label:** Placebo ointment

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mupirocin ointment

**Description:** 0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)

**Name:** Mupirocin calcium ointment, 2%

**Other Names:**

- Bactroban Nasal 2%

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo ointment

**Description:** Placebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)

**Name:** Placebo ointment

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Nasal colonization with Staphylococcus aureus

**Time Frame:** monthly assessment of colonization (~1 month after each treatment)

#### Secondary Outcomes

**Measure:** Infection with Staphylococcus aureus

**Time Frame:** monthly

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Resident at Project Samaritan Inc. (PSI)

Exclusion Criteria:

* Past hypersensitivity to mupirocin or glycerol
* Pregnancy
* Lactation
* Expected discharge from PSI in the following month
* Treatment with intranasal mupirocin within the preceding two months

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bronx

**Country:** United States

**Facility:** Project Samaritan Inc.

**State:** New York

**Zip:** 10452

**Location 2:**

**City:** New York

**Country:** United States

**Facility:** Columbia University

**State:** New York

**Zip:** 10032

#### Overall Officials

**Official 1:**

**Affiliation:** Columbia University

**Name:** Rachel J Gordon, MD, MPH

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Columbia University

**Name:** Franklin D Lowy, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 20686410

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

- ID: D000012897

- Term: Slow Virus Diseases

- ID: D000016908

- Term: Gram-Positive Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: HIGH

- As Found: HIV Infections

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: HIV Infections

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M15996

- Name: Staphylococcal Infections

- Relevance: HIGH

- As Found: Staphylococcus Aureus

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15700

- Name: Slow Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M19252

- Name: Gram-Positive Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000015658

- Term: HIV Infections

- ID: D000000163

- Term: Acquired Immunodeficiency Syndrome

- ID: D000013203

- Term: Staphylococcal Infections

### Intervention Browse Module - Ancestors

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000011500

- Term: Protein Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M5381

- Name: Calcium

- Relevance: HIGH

- As Found: Radiation

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M19075

- Name: Mupirocin

- Relevance: HIGH

- As Found: Bispectral Index

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016712

- Term: Mupirocin

- ID: D000002118

- Term: Calcium

### Misc Info Module

- Version Holder: 2024-05-24
