Staphylococcus AureusPhase 4NCT00801879
Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection
A Phase 4 study testing Mupirocin calcium ointment, 2% in people with Staphylococcus Aureus and HIV Infections, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus, HIV Infections
- What is being tested?
- Mupirocin calcium ointment, 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2003to Apr 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resident at Project Samaritan Inc. (PSI)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University
New York, New York, 10032
Project Samaritan Inc.
The Bronx, New York, 10452
About this study
Official title: Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection
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
Read the 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
- Staphylococcus Aureus, HIV Infections
- Being tested
- Mupirocin calcium ointment, 2%, Placebo ointment
- Keywords
- mupirocin, Staphylococcus aureus, colonization, infection, HIV
- Medical subject headings
- Staphylococcal Infections, HIV Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin calcium ointment, 2%Drug
Also called Bactroban Nasal 2%
0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months)
Placebo ointmentDrug
Placebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Mupirocin calcium ointment, 2% |
| Placebo ointment | Placebo comparator | 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months) Receives: Drug: Placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal colonization with Staphylococcus aureus
Measured: monthly assessment of colonization (~1 month after each treatment)
Secondary outcomes (1)
Infection with Staphylococcus aureus
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startSep 2003
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franklin D. Lowy, Columbia University
- Investigators
- Rachel J Gordon, MD, MPH, Study director, Columbia UniversityFranklin D Lowy, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801879
- Sponsor's protocol ID
- AAAB0129
- Other IDs
- K08AI072043
- Status last verified
- Oct 2014
- First submitted
- 3 Dec 2008
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20686410
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Mupirocin to Eliminate Carriage of Staphylococcus Aureus in HIV Infection
- ClinicalTrials.gov ID
- NCT00801879
- Acronym / sponsor ID
- AAAB0129
- Conditions
- Staphylococcus Aureus, HIV Infections
- Keywords
- mupirocin, Staphylococcus aureus, colonization, infection, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mupirocin ointment | Active comparator | Drug: Mupirocin calcium ointment, 2%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 | Drug: Placebo ointment0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resident at Project Samaritan Inc. (PSI)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mupirocin calcium ointment, 2%Also: Bactroban Nasal 2%0.25 g in each nostril twice daily for 5 days (given monthly for up to 8 months) | Drug | Mupirocin ointment |
| Placebo ointmentPlacebo ointment 0.25g in each nostril twice daily for 5 days (repeated monthly for up to 8 months) | Drug | Placebo ointment |
Primary outcome
Nasal colonization with Staphylococcus aureus
Time frame: monthly assessment of colonization (~1 month after each treatment)
1 secondary outcome
Infection with Staphylococcus aureus
Time frame: monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Results publication: PubMed 20686410Gordon 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel J Gordon, MD, MPH study director
Columbia University
Franklin D Lowy, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mupirocin calcium ointment, 2% in people with Staphylococcus Aureus and HIV Infections, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal colonization with Staphylococcus aureus (time frame: monthly assessment of colonization (~1 month after each treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.