Preventing Staphylococcal (Staph) Infection

NCT00108160 | Completed Phase 4 Results

• 1 other identifier: CLNB-001-04S
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if mupirocin 2% in polyethylene glycol (PEG) ointment \[Treatment Arm\] is effective in preventing moderate to severe re-infection with Staphylococcus aureus compared with treatment with polyethylene glycol (PEG) ointment \[Placebo Arm\].

Conditions

Staphylococcal Infections

Keywords

mupirocin; prevention and control; s. aureus

Outcome Measures

Primary Outcomes (1)

• Re-infection With S. Aureus

  During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)

  18 months

Secondary Outcomes (1)

• Acquisition of New S. Aureus Strains

  18 months

Other Outcomes (1)

• S. Aureus Re-infections (New or Recurrent)

  18 months

Study Arms (2)

Mupirocin Ointment [Treatment]

ACTIVE COMPARATOR

Treatment arm or active comparator \[mupirocin 2% polyethylene glycol (PEG) ointment\] will be compared with its placebo comparator \[polyethylene glycol (PEF) in patients with a prior history of S. aureus infection. Drug or placebo will be applied topically to nares and/or wounds twice daily for 14 days at 3 month intervals for up to 18 months

Drug: Mupirocin Ointment [Treatment]

Polyethylene Glycol Ointment [Placebo]

PLACEBO COMPARATOR

Treatment arm or active comparator \[mupirocin 2% polyethylene glycol (PEG) ointment\] will be compared with its placebo comparator \[polyethylene glycol (PEF) in patients with a prior history of S. aureus infection. Drug or placebo will be applied topically to nares and/or wounds twice daily for 14 days at 3 month intervals for up to 18 months

Drug: Polyethylene Glycol Ointment [Placebo]

Interventions

Mupirocin Ointment [Treatment] DRUG

The impact of the treatment arm versus placebo arm on development of new (recurrent) S. aureus infection will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.

Also known as: Bactroban ointment, Mupirocin 2% in Polyethylene Glycol (PEG) Ointment

Mupirocin Ointment [Treatment]

Polyethylene Glycol Ointment [Placebo] DRUG

The impact of the treatment arm versus placebo arm on development of S. aureus re-infections will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.

Also known as: PEG Ointment

Polyethylene Glycol Ointment [Placebo]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who receive care at Ann Arbor VA Medical Center, University of Michigan Medical Center, or St. Joseph Mercy Hospital, Ypsilanti who have been hospitalized for documented S. aureus infection will be eligible for enrollment. Staphylococcal infections may be community or hospital-acquired. Patients with S. aureus infection will be identified on a daily basis with the assistance of the Infection Control Practitioner, the Clinical Microbiology Laboratory, the Infectious Diseases Consultation Services, and Infectious Diseases physicians caring for patients in their offices.
• Patients will provide written informed consent. The patient's guardian or next of kin will be contacted for informed consent in the event that the patient is incapable of doing so.

You may not qualify if:

• Patients who are unable to cooperate with treatment or follow-up.
• Patients who are not likely to survive beyond one month or those who are transferred back to another acute care hospital.
• Patients who require treatment with rifampin will be excluded since this drug is effective in decolonization of some staphylococcal carriers.
• Patients with known hypersensitivity to mupirocin ointment or polyethylene glycol base.
• Patients with ulcers obviously related to pressure will be excluded because they are frequently large, difficult to keep clean, and infections are difficult to diagnose.
• Patients with small vascular or neuropathic ulcers \< 3 cm in circumference and \< 2 cm in depth may be enrolled.
• Pregnant women.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of Michigan: collaborator
• Trinity Health Michigan: collaborator

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Therapeutics; Mupirocin; Polyethylene Glycols; Ointments

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Ethylene Glycols; Glycols; Alcohols; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

The study is underpowered to detect differences between the two treatment arms. We achieved only 75% of target enrollment, and 41.1% dropped out before reaching a primary endpoint. Our re-infection rate was also lower than anticipated (14.4%).

Results Point of Contact

• Title: Suzanne F. Bradley, M.D.
• Organization: VA Ann Arbor Healthcare System

sbradley@umich.edu

734-845-5820

Study Officials

• Suzanne Bradley, MD

  VA Ann Arbor Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2005
• First Posted: April 15, 2005
• Study Start: April 1, 2005
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 16, 2014
• Results First Posted: February 4, 2014

Record last verified: 2014-03

Locations

US (1)