Trial Outcomes & Findings for Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial (NCT NCT02223520)

Last Updated: 2022-01-11

Results Overview

Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

307 participants

Primary outcome timeframe

Up to 90 days

Results posted on

2022-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	Mupirocin and Chlorhexidine Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days. Mupirocin and Chlorhexidine	Placebo Ointment and Placebo Cloths Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days. Placebo ointment and placebo cloths
Overall Study STARTED	147	160
Overall Study COMPLETED	147	160
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This baseline measure reported is for the neonates not the parents.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 90 days

Population: This outcome is being assessed in the neonate population not the mothers. 12 of the neonates in the intervention group and 6 in the placebo group were lost to follow-up and could not be included in the analysis.

Outcome measures

Outcome measures
Measure	Mupirocin and Chlorhexidine n=89 Participants Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days. Mupirocin and Chlorhexidine	Placebo Ointment and Placebo Cloths n=101 Participants Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days. Placebo ointment and placebo cloths
Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain	13 neonatal S. aureus infections	29 neonatal S. aureus infections

Adverse Events

Mupirocin and Chlorhexidine

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo Ointment and Placebo Cloths

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mupirocin and Chlorhexidine n=147 participants at risk Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days. Mupirocin and Chlorhexidine	Placebo Ointment and Placebo Cloths n=160 participants at risk Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days. Placebo ointment and placebo cloths
Skin and subcutaneous tissue disorders Skin irritation	4.8% 7/147 • Number of events 7 • During the 5 days of treatment Adverse events were assessed in mothers not neonates.	6.2% 10/160 • Number of events 10 • During the 5 days of treatment Adverse events were assessed in mothers not neonates.
Respiratory, thoracic and mediastinal disorders Nose irritation	0.68% 1/147 • Number of events 1 • During the 5 days of treatment Adverse events were assessed in mothers not neonates.	0.00% 0/160 • During the 5 days of treatment Adverse events were assessed in mothers not neonates.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.68% 1/147 • Number of events 1 • During the 5 days of treatment Adverse events were assessed in mothers not neonates.	3.1% 5/160 • Number of events 5 • During the 5 days of treatment Adverse events were assessed in mothers not neonates.
Pregnancy, puerperium and perinatal conditions Retained placenta	0.00% 0/147 • During the 5 days of treatment Adverse events were assessed in mothers not neonates.	0.62% 1/160 • Number of events 1 • During the 5 days of treatment Adverse events were assessed in mothers not neonates.

Additional Information

Aaron M. Milstone, M.D., M.H.S.

Johns Hopkins Medical Institutions

Phone: 410-614-3917

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Mupirocin and Chlorhexidine n=147 Participants Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days. Mupirocin and Chlorhexidine	Placebo Ointment and Placebo Cloths n=160 Participants Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days. Placebo ointment and placebo cloths	Total n=307 Participants Total of all reporting groups
Age, Continuous	7.9 days STANDARD_DEVIATION 5.1 • n=101 Participants • This baseline measure reported is for the neonates not the parents.	7.2 days STANDARD_DEVIATION 5.3 • n=107 Participants • This baseline measure reported is for the neonates not the parents.	7.54 days STANDARD_DEVIATION 5.2 • n=208 Participants • This baseline measure reported is for the neonates not the parents.
Sex: Female, Male Female	47 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	47 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	94 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Sex: Female, Male Male	54 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	60 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	114 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	3 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	11 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	95 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	181 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	9 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	16 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	0 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	0 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Race (NIH/OMB) Asian	3 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	11 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	14 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	0 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	0 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Race (NIH/OMB) Black or African American	27 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	30 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	57 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Race (NIH/OMB) White	66 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	59 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	125 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Race (NIH/OMB) More than one race	0 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	0 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	0 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	7 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	12 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Region of Enrollment United States · Johns Hopkins Hospital	93 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	99 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	192 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Region of Enrollment United States · Johns Hopkins Bayview	8 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	8 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	16 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Parent age at the time of enrollment	30.3 years STANDARD_DEVIATION 5.9 • n=134 Participants • This is a measure for the parents. Parent demographics collected by parent interview or parent completion of form. Parents sometimes skipped questions on survey form and were not always available to capture missing demographic data that was not in the medical record.	30.9 years STANDARD_DEVIATION 7.7 • n=146 Participants • This is a measure for the parents. Parent demographics collected by parent interview or parent completion of form. Parents sometimes skipped questions on survey form and were not always available to capture missing demographic data that was not in the medical record.	30.6 years STANDARD_DEVIATION 6.9 • n=280 Participants • This is a measure for the parents. Parent demographics collected by parent interview or parent completion of form. Parents sometimes skipped questions on survey form and were not always available to capture missing demographic data that was not in the medical record.
Parent antibiotic use in past 6 months Yes	59 Participants n=147 Participants	54 Participants n=160 Participants	113 Participants n=307 Participants
Parent antibiotic use in past 6 months No	73 Participants n=147 Participants	88 Participants n=160 Participants	161 Participants n=307 Participants
Parent antibiotic use in past 6 months Unreported/Unknown	15 Participants n=147 Participants	18 Participants n=160 Participants	33 Participants n=307 Participants
Parent history of mupirocin use Yes	6 Participants n=147 Participants	5 Participants n=160 Participants	11 Participants n=307 Participants
Parent history of mupirocin use No	121 Participants n=147 Participants	133 Participants n=160 Participants	254 Participants n=307 Participants
Parent history of mupirocin use Unreported/Unknown	20 Participants n=147 Participants	22 Participants n=160 Participants	42 Participants n=307 Participants
Parent history of Staphylococcus aureus infection Yes	6 Participants n=147 Participants	9 Participants n=160 Participants	15 Participants n=307 Participants
Parent history of Staphylococcus aureus infection No	122 Participants n=147 Participants	128 Participants n=160 Participants	250 Participants n=307 Participants
Parent history of Staphylococcus aureus infection Unreported/Unknown	19 Participants n=147 Participants	23 Participants n=160 Participants	42 Participants n=307 Participants
Level of education of parent At most high school	26 Participants n=147 Participants	33 Participants n=160 Participants	59 Participants n=307 Participants
Level of education of parent Some or completed college	71 Participants n=147 Participants	59 Participants n=160 Participants	130 Participants n=307 Participants
Level of education of parent Graduate degree	24 Participants n=147 Participants	38 Participants n=160 Participants	62 Participants n=307 Participants
Level of education of parent Unknown	26 Participants n=147 Participants	30 Participants n=160 Participants	56 Participants n=307 Participants
No. of singletons	78 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	81 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	159 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Birthweight of neonate	1982.5 grams STANDARD_DEVIATION 972.8 • n=101 Participants • This baseline measure reported is for the neonates not the parents.	1986.9 grams STANDARD_DEVIATION 949.4 • n=107 Participants • This baseline measure reported is for the neonates not the parents.	1984.8 grams STANDARD_DEVIATION 958.5 • n=208 Participants • This baseline measure reported is for the neonates not the parents.
Child delivery method Vaginal birth	68 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	72 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	140 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Child delivery method Cesarean section	33 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	35 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	68 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Neonate inborn or transferred in Inborn in JHH/JHBMC	91 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	97 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	188 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Neonate inborn or transferred in Transferred from another hospital to JHH/JHBMC	10 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	8 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	18 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Neonate inborn or transferred in Transferred from home to JHH/JHBMC	0 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	2 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	2 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Gestational age at birth	32.9 weeks STANDARD_DEVIATION 4.7 • n=101 Participants • This baseline measure reported is for the neonates not the parents.	33.1 weeks STANDARD_DEVIATION 4.4 • n=107 Participants • This baseline measure reported is for the neonates not the parents.	33 weeks STANDARD_DEVIATION 4.5 • n=208 Participants • This baseline measure reported is for the neonates not the parents.
Maternal antibiotic use during delivery	68 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	64 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	132 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Maternal Group B Streptococcus positive Positive	21 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	21 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	42 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Maternal Group B Streptococcus positive Negative	32 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	43 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	75 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Maternal Group B Streptococcus positive Unreported/Unknown	48 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	43 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	91 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Maternal HIV Positive Positive	1 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	2 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	3 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Maternal HIV Positive Negative	92 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	94 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	186 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.
Maternal HIV Positive Unreported/Unknown	8 Participants n=101 Participants • This baseline measure reported is for the neonates not the parents.	11 Participants n=107 Participants • This baseline measure reported is for the neonates not the parents.	19 Participants n=208 Participants • This baseline measure reported is for the neonates not the parents.