## Protocol Section
### Identification Module
**NCT ID:** NCT00903279

**Acronym:** TOPS-MRSA

**Brief Title:** Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery

**Official Title:** Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)

#### Organization Study ID Info
**ID:** TOPS2009
#### Organization
**Class:** FED
**Full Name:** Bay Pines VA Healthcare System
### Status Module
#### Completion Date
**Date:** 2010-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-01-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-01-30

**Overall Status:** WITHDRAWN

#### Start Date
**Date:** 2009-08

**Status Verified Date:** 2009-05

#### Study First Post Date
**Date:** 2009-05-18
**Type:** ESTIMATED
**Study First Submit Date:** 2009-05-14
**Study First Submit QC Date:** 2009-05-14
**Why Stopped:** Funding
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** FED

**Name:** Bay Pines VA Healthcare System

#### Responsible Party

**Old Name Title:** David P. Johnson, MD

**Old Organization:** Bay Pines VAHCS

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.

**Detailed Description:** Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.

### Conditions Module

**Conditions:**

- Orthopedic Procedures

- Methicillin-resistant Staphylococcus Aureus

**Keywords:**

- MRSA colonization

- Orthopedic Surgery

- Altabax

- Placebo

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Altabax (retapamulin)

**Label:** Altabax

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Placebo

**Description:** Placebo will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.

**Name:** Placebo

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Altabax

**Description:** Retapamulin 1% ointment will be administered intranasally an amount approximating 0.25 ml will be applied to each nasal vestibule by sterile cotton applicator in the evening prior to surgery and immediately on call on the day of surgery.

**Name:** Altabax (retapamulin)

**Other Names:**

- Retapamulin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization

**Time Frame:** 30 days

#### Secondary Outcomes

**Measure:** Identify a predominant clone among the MRSA isolates in this study

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients who are admitted for an orthopedic surgical procedure
* All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA

Exclusion Criteria:

* Pregnancy
* Serious systemic illness due to renal, cardiac or hepatic disease
* Inability to complete follow-up assessments
* Allergy or intolerance to retapamulin
* BMI \> 30
* Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy
* Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled
* Antibiotics administered during the course of the study will be recorded (name, dose and dates)

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bay Pines

**Country:** United States

**Facility:** Bay Pines VAHCS

**State:** Florida

**Zip:** 33744

#### Overall Officials

**Official 1:**

**Affiliation:** Bay Pines VAHCS

**Name:** Suzane Silbert, PhD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016908

- Term: Gram-Positive Bacterial Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15996

- Name: Staphylococcal Infections

- Relevance: HIGH

- As Found: Methicillin-resistant Staphylococcus Aureus

- 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: D000013203

- Term: Staphylococcal Infections

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M97132

- Name: Retapamulin

- Relevance: HIGH

- As Found: Competition

- ID: M11688

- Name: Methicillin

- 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

### Intervention Browse Module - Meshes

- ID: C000508887

- Term: Retapamulin

### Misc Info Module

- Version Holder: 2024-05-24
