Trial · NCT00980980
Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs)
NCT00980980, Not applicable, Completed, Harvard Pilgrim Health Care; results first posted 2014-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs). Trials, record NCT00980980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00980980
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs)
- NCT number
- NCT00980980
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 74,256 participants, actual
- Lead sponsor
- Harvard Pilgrim Health Care
- Conditions
- Methicillin-resistant Staphylococcus Aureus
- Interventions
- Chlorhexidine bath and nasal mupirocin
- First posted
- 2009-09-21
- Last updated
- 2017-05-02
- Results first posted
- 2014-07-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Main Outcome: Patients With Nosocomial MRSA Clinical Cultures | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. | Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. |
| Secondary | MRSA Bloodstream Infection | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. | Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. |
| Secondary | ICU-attributable All-pathogen Bloodstream Infection | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. | Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital. |
| Secondary | Intervention Impact on Healthcare Costs | 12-month period | Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3). |
| Secondary | Blood Culture Contamination Rates | 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period. | Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. |
| Secondary | Intervention Impact on Bacteriuria and Candiduria | 30-month time frame represents 12-month baseline and 18-month intervention periods. | Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL. |
| Secondary | Intervention Impact on Mupirocin Susceptibility of MRSA Isolates | 25-month time frame represents 7-month baseline and 18-month intervention periods | Odds ratio for MRSA+ isolates from ICU patients expressing low-level mupirocin resistance (LLMR) and high-level mupirocin resistance (HLMR), comparing baseline to intervention period across arms, accounting for clustering by hospital. |
| Secondary | Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates | 25-month time frame represents 7-month baseline and 18-month intervention periods | Frequency of MRSA+ isolates from ICU patients with reduced susceptibility to chlorhexidine (CHG) (MIC \>4 μg/ml), comparing baseline to intervention period across arms, accounting for clustering by hospital. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Main Outcome: Patients With Nosocomial MRSA Clinical Cultures | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. | The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm. | hazard ratio | NUMBER |
| SECONDARY | MRSA Bloodstream Infection | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. | The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm. | hazard ratio | NUMBER |
| SECONDARY | ICU-attributable All-pathogen Bloodstream Infection | The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. | The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm. | Hazard ratio | NUMBER |
| SECONDARY | Intervention Impact on Healthcare Costs | 12-month period | Annual adult ICU admissions per hospital, over the course of 1 year. | Dollars per 1000 ICU-admissions | NUMBER |
| SECONDARY | Blood Culture Contamination Rates | 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period. | The number of participants analyzed reflects the combined total of baseline and intervention admissions, with an ICU stay and a blood draw set, for each arm. | Odds Ratio | NUMBER |
| SECONDARY | Intervention Impact on Bacteriuria and Candiduria | 30-month time frame represents 12-month baseline and 18-month intervention periods. | The number of participants analyzed reflects the combined total of baseline and intervention admissions with an ICU stay, for each arm. | Hazard Ratio | NUMBER |
| SECONDARY | Intervention Impact on Mupirocin Susceptibility of MRSA Isolates | 25-month time frame represents 7-month baseline and 18-month intervention periods | The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm. | Odds Ratio | NUMBER |
| SECONDARY | Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates | 25-month time frame represents 7-month baseline and 18-month intervention periods | The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm. | MRSA isolates non-susceptible to CHG | NUMBER |
Source ClinicalTrials.gov
Results by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Main Outcome: Patients With Nosocomial MRSA Clinical Cultures | Arm 1: Usual Care-Active Surveillance | 0.92 | 95% Confidence Interval 0.77 to 1.10 | hazard ratio | |
| Main Outcome: Patients With Nosocomial MRSA Clinical Cultures | Arm 2: Targeted Decolonization | 0.75 | 95% Confidence Interval 0.63 to 0.89 | hazard ratio | |
| Main Outcome: Patients With Nosocomial MRSA Clinical Cultures | Arm 3: Universal Decolonization | 0.63 | 95% Confidence Interval 0.52 to 0.75 | hazard ratio | |
| MRSA Bloodstream Infection | Arm 1: Usual Care-Active Surveillance | 1.23 | 95% Confidence Interval 0.82 to 1.85 | hazard ratio | |
| MRSA Bloodstream Infection | Arm 2: Targeted Decolonization | 1.23 | 95% Confidence Interval 0.80 to 1.90 | hazard ratio | |
| MRSA Bloodstream Infection | Arm 3: Universal Decolonization | 0.72 | 95% Confidence Interval 0.48 to 1.08 | hazard ratio | |
| ICU-attributable All-pathogen Bloodstream Infection | Arm 1: Usual Care-Active Surveillance | 0.99 | 95% Confidence Interval 0.84 to 1.16 | Hazard ratio | |
| ICU-attributable All-pathogen Bloodstream Infection | Arm 2: Targeted Decolonization | 0.78 | 95% Confidence Interval 0.66 to 0.91 | Hazard ratio | |
| ICU-attributable All-pathogen Bloodstream Infection | Arm 3: Universal Decolonization | 0.56 | 95% Confidence Interval 0.49 to 0.65 | Hazard ratio | |
| Intervention Impact on Healthcare Costs | Arm 1: Usual Care-Active Surveillance | Cost of MRSA screening tests | 9,120 | Dollars per 1000 ICU-admissions |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Usual Care-Active Surveillance | 16 | |
| Overall Study | STARTED | Arm 2: Targeted Decolonization | 14 | |
| Overall Study | STARTED | Arm 3: Universal Decolonization | 13 | |
| Overall Study | COMPLETED | Arm 1: Usual Care-Active Surveillance | 16 | |
| Overall Study | COMPLETED | Arm 2: Targeted Decolonization | 13 | |
| Overall Study | COMPLETED | Arm 3: Universal Decolonization | 13 | |
| Overall Study | NOT COMPLETED | Arm 1: Usual Care-Active Surveillance | 0 | |
| Overall Study | NOT COMPLETED | Arm 2: Targeted Decolonization | 1 | |
| Overall Study | NOT COMPLETED | Arm 3: Universal Decolonization | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild | Skin and subcutaneous tissue disorders | Arm 1: Usual Care-Active Surveillance | 0 | 23,480 | 0 |
| other | Mild | Skin and subcutaneous tissue disorders | Arm 2: Targeted Decolonization | 2 | 24,752 | 2 |
| other | Mild | Skin and subcutaneous tissue disorders | Arm 3: Universal Decolonization | 5 | 26,024 | 5 |
| other | Moderate | Skin and subcutaneous tissue disorders | Arm 1: Usual Care-Active Surveillance | 0 | 23,480 | 0 |
| other | Moderate | Skin and subcutaneous tissue disorders | Arm 2: Targeted Decolonization | 0 | 24,752 | 0 |
| other | Moderate | Skin and subcutaneous tissue disorders | Arm 3: Universal Decolonization | 0 | 26,024 | 0 |
| other | Severe | Skin and subcutaneous tissue disorders | Arm 1: Usual Care-Active Surveillance | 0 | 23,480 | 0 |
| other | Severe | Skin and subcutaneous tissue disorders | Arm 2: Targeted Decolonization | 0 | 24,752 | 0 |
| other | Severe | Skin and subcutaneous tissue disorders | Arm 3: Universal Decolonization | 0 | 26,024 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Usual Care-Active Surveillance | ||
| Total, all-cause mortality | Arm 2: Targeted Decolonization | ||
| Total, all-cause mortality | Arm 3: Universal Decolonization | ||
| Total, other adverse events | Arm 1: Usual Care-Active Surveillance | 0 | 23,480 |
| Total, other adverse events | Arm 2: Targeted Decolonization | 2 | 24,752 |
| Total, other adverse events | Arm 3: Universal Decolonization | 5 | 26,024 |
| Total, serious adverse events | Arm 1: Usual Care-Active Surveillance | 0 | 23,480 |
| Total, serious adverse events | Arm 2: Targeted Decolonization | 0 | 24,752 |
| Total, serious adverse events | Arm 3: Universal Decolonization | 0 | 26,024 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00980980
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