Trial Outcomes & Findings for A Novel Approach to Methicillin-resistant Staphylococcus Aureus (MRSA) Screening of Colonized Patients (NCT NCT01234831)

Results Overview

This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

463 participants

Primary outcome timeframe

1 year

Results posted on

2017-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Active Screening Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.	Passive Screening Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
Overall Study STARTED	261	202
Overall Study COMPLETED	259	198
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Novel Approach to Methicillin-resistant Staphylococcus Aureus (MRSA) Screening of Colonized Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Screening n=261 Participants Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.	Passive Screening n=202 Participants Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.	Total n=463 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	126 Participants n=5 Participants	96 Participants n=7 Participants	222 Participants n=5 Participants
Age, Categorical >=65 years	135 Participants n=5 Participants	106 Participants n=7 Participants	241 Participants n=5 Participants
Age, Continuous	63.9 years STANDARD_DEVIATION 16.77 • n=5 Participants	62.9 years STANDARD_DEVIATION 18.45 • n=7 Participants	63.47 years STANDARD_DEVIATION 17.51 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	86 Participants n=7 Participants	177 Participants n=5 Participants
Sex: Female, Male Male	170 Participants n=5 Participants	116 Participants n=7 Participants	286 Participants n=5 Participants
Region of Enrollment United States	261 participants n=5 Participants	202 participants n=7 Participants	463 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Only patients randomized to the Active Screening arm who had 3 pairs of completed nasal swabs could be analyzed for this outcome measure which is the negative predictive value of the first PCR sample compared to three culture samples for subjects with a history of prior MRSA infection or colonization.

This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization.

Outcome measures

Outcome measures
Measure	Active Screening n=191 Participants Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.	Passive Screening Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays	96.6 percentage of participants Interval 91.6 to 99.1	—

PRIMARY outcome

Timeframe: 1 year

Population: Participants in both the Active Screening arm and Passive Screening arm who completed the 3-swab protocol.

Rate at which subjects in both trial arms complete the 3-swab protocol.

Outcome measures

Outcome measures
Measure	Active Screening n=259 Participants Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.	Passive Screening n=198 Participants Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
Completion of Screening Protocol in Both Trial Arms	73.7 percentage of subjects completed 3 swabs	9.6 percentage of subjects completed 3 swabs

PRIMARY outcome

Timeframe: 1 year

Population: Analysis was performed on patients in both the Active Screening arm and Passive Screening arm who had completed the 3-swab protocol and all 3 swabs were negative.

Patients known to have MRSA require Contact Precautions based on current recommendations from the Center for Disease Control and Prevention (CDC). Contact Precautions mean that hospitalized patients with a history of MRSA infection or colonization are isolated in a private room or together with patients who have the same Contact Precautions status (i.e. both with MRSA). Healthcare workers caring for such patients must wear protective gowns and gloves during interactions and use of equipment dedicated to that patient is recommended. For this study, "Contact Precautions are discontinued" refers to the practice of discontinuation of Contact Precautions once subjects meet criteria based on institutional infection control policy: history of MRSA but no positive culture in preceding 90 days and three negative nasal surveillance cultures obtained at least 24 hours apart in the absence of concurrent antibiotic use.

Outcome measures

Outcome measures
Measure	Active Screening n=125 Participants Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.	Passive Screening n=15 Participants Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
Discontinuation of Contact Precautions in Both Trial Arms	55.2 percentage of MRSA CP discontinued	86.7 percentage of MRSA CP discontinued

SECONDARY outcome

Timeframe: 1 year

Population: Number of participants in the Active Screening arm who had completed the 3-swab protocol.

This outcome is the positive predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization who completed the 3 swab protocol.

Outcome measures

Outcome measures
Measure	Active Screening n=191 Participants Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.	Passive Screening Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay	62 participants	—

SECONDARY outcome

Timeframe: 1 year

Sensitivity of the first PCR assay for subjects enrolled in active arm of trial.

Outcome measures

Outcome measures
Measure	Active Screening n=191 Participants Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.	Passive Screening Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
Sensitivity of First PCR Assay	93.9 percentage of true positives Interval 85.4 to 97.6	—

SECONDARY outcome

Timeframe: 1 year

Specificity of the first PCR assay for subjects enrolled in active arm of trial.

Outcome measures

Outcome measures
Measure	Active Screening n=191 Participants Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.	Passive Screening Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
Specificity of First PCR Assay.	92.0 percentage of true negatives Interval 85.9 to 95.6	—

SECONDARY outcome

Timeframe: 2 years

Population: We reviewed the data on the 69 subjects who were enrolled in the intervention arm of the trial who were cleared of colonization based on the study intervention.

Prospective review of microbiological data for patients enrolled in the trial to determine rate of recolonization or documented infection. Subjects in the Intervention Arm of the study who had documented clearance of colonization and met criteria for discontinuation of contract precautions, and had CP discontinued by staff (N=69) were included. Subjects who had a visit at MGH through 12/31/2012 during which a microbiology sample was obtained and MRSA was recovered (clinical or surveillance) were included.

Outcome measures

Outcome measures
Measure	Active Screening n=69 Participants Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.	Passive Screening Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
Rate of Recolonization or Documented Infection With MRSA	8 Participants	—

Adverse Events

Active Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erica S. Shenoy

Massachusetts General Hospital

Phone: 617-726-2036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place