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Clinical Trials

Bactroban Nasal 2% (mupirocin calcium ointment)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 1996

Specific Treatments:

nasal bacteria

General Information

Bactroban Nasal has been approved as an intranasally administered topical agent for the eradication of nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA). This treatment has been approved for adult subjects and health care workers as part of a comprehensive infection control program to reduce the risk of MRSA infection during institutional outbreaks of infections with this pathogen. A problem first confined to tertiary care centers and large teaching hospitals, MRSA outbreaks increasingly affect hospitals and other health care institutions of all sizes and, once established, have proven extremely difficult to eradicate.

Bactroban Nasal is available in a one-gram single-use applicator tube and is formulated specifically for intranasal use. The recommended course of therapy is twice daily application for five days.

Clinical Results

Analysis of six U.S. clinical trials designed to evaluate the effectiveness of Bactroban Nasal in eliminating S. aureus from the nostrils in health care workers showed that of the volunteers evaluated for efficacy, nasal carriage of S. aureus was eliminated in 91% of volunteers receiving Bactroban Nasal, but only 6% of volunteers receiving placebo. In addition, 74% of the volunteers treated with Bactroban Nasal who were free of S. aureus at the end of therapy (five days) remained free of the bacteria four weeks after treatment compared with 12.5% of the placebo volunteers. No serious side effects were reported. Only one of 339 participants withdrew from the study due to a side effect.

Side Effects

The most frequently reported side effects associated with Bactroban Nasal were headache (9%), rhinitis (6%), and respiratory disorder including upper respiratory tract congestion (5%).

Additional Information

According to an estimate from the Centers for Disease Control and Prevention (CDC), each year approximately two million patients in the United States contract hospital-acquired infections. Further complicating this problem is antibiotic resistance, which hampers treatment of the infections.

Subjects at high risk of MRSA infection may include those undergoing surgery and those being treated in intensive care units. For this reason, it is important to contain nasal carriage of MRSA. By eradicating MRSA from the nose, Bactroban Nasal interrupts the transmission of the bacteria to a potential site of infection.

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