Trial Outcomes & Findings for Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization (NCT NCT03118232)
NCT ID: NCT03118232
Last Updated: 2023-12-27
Results Overview
Probability that a transfer to a hospital is due to an infection
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
13952 participants
Primary outcome timeframe
18 months
Results posted on
2023-12-27
Participant Flow
Unit of analysis: Nursing Homes
Participant milestones
| Measure |
Decolonization
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Chlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
Iodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
|
Routine Bathing
Routine bathing per facility protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
7388 14
|
6564 14
|
|
Overall Study
COMPLETED
|
7388 14
|
6564 14
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Baseline characteristics by cohort
| Measure |
Decolonization
n=7388 Participants
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Chlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
Iodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
|
Routine Bathing
n=6564 Participants
Routine bathing per facility protocol.
|
Total
n=13952 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.7 years
STANDARD_DEVIATION 4.2 • n=93 Participants
|
76.6 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
76.2 years
STANDARD_DEVIATION 5.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4180 Participants
n=93 Participants
|
3602 Participants
n=4 Participants
|
7782 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3208 Participants
n=93 Participants
|
2962 Participants
n=4 Participants
|
6170 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1042 Participants
n=93 Participants
|
1312 Participants
n=4 Participants
|
2354 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
841 Participants
n=93 Participants
|
1042 Participants
n=4 Participants
|
1883 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3749 Participants
n=93 Participants
|
2666 Participants
n=4 Participants
|
6415 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1756 Participants
n=93 Participants
|
1544 Participants
n=4 Participants
|
3300 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
7388 Participants
n=93 Participants
|
6564 Participants
n=4 Participants
|
13952 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Analysis is of residents accounting for clustering in 28 nursing homes
Probability that a transfer to a hospital is due to an infection
Outcome measures
| Measure |
Decolonization
n=7388 Participants
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Chlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
Iodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
|
Routine Bathing
n=6564 Participants
Routine bathing per facility protocol.
|
|---|---|---|
|
Hospital Transfers Due to Infection
|
1243 Transfers
|
1780 Transfers
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Analysis is of residents accounting for clustering in 28 nursing homes
Probability that a discharge is to a hospital
Outcome measures
| Measure |
Decolonization
n=7388 Participants
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Chlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
Iodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
|
Routine Bathing
n=6564 Participants
Routine bathing per facility protocol.
|
|---|---|---|
|
All Hospital Transfers
|
2388 Transfers
|
2857 Transfers
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Once in baseline and once at end-intervention (month 15-18 of intervention period)Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)
Outcome measures
| Measure |
Decolonization
n=550 Participants
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Chlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
Iodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
|
Routine Bathing
n=650 Participants
Routine bathing per facility protocol.
|
|---|---|---|
|
Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)
|
176 Participants
|
307 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsProbability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsProbability that a discharge is to a hospital for long stay and short stay resident subsets
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsProbability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets
Outcome measures
Outcome data not reported
Adverse Events
Decolonization
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Routine Bathing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Decolonization
n=7388 participants at risk
Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.
Chlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
Iodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
|
Routine Bathing
n=6564 participants at risk
Routine bathing per facility protocol.
|
|---|---|---|
|
Product Issues
Rashes
|
0.46%
34/7388 • Number of events 34 • 18 months
|
0.00%
0/6564 • 18 months
|
|
Product Issues
Sore throat
|
0.01%
1/7388 • Number of events 1 • 18 months
|
0.00%
0/6564 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place