Staph Aureus Colonization, Staph Aureus Infection
Conditions
Keywords
Staphylococcus aureus, Infection, Colonization, Transmission, Neonate
Brief summary
This trial will test the hypothesis that treating parents of neonates requiring NICU care with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S. aureus from parents to neonates.
Detailed description
The TREAT PARENTS Trial, or Treating Parents to Reduce NICU Transmission of S. aureus, is a placebo-controlled, double-masked, randomized clinical trial to test the hypothesis that treatment of S. aureus colonized parents with intranasal mupirocin and topical chlorhexidine gluconate antisepsis will decrease neonatal S. aureus acquisition. All neonates admitted to the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center NICUs will be pre-screened and parents will be approached for enrollment in the study. After consent and baseline screening, 400 neonate-parent pairs will be randomized; only neonates who have a parent colonized with S. aureus will be randomized. Parents will receive a 5 day treatment with intranasal mupirocin plus topical chlorhexidine gluconate antisepsis or placebo. After recruitment and informed consent, parents will undergo pre-randomization screening. If both parents screen negative for S. aureus colonization, the neonate will be ineligible for the randomization and parents will be informed that the parents are not colonized at that time with S. aureus. If either parent screens positive for S. aureus, then both parents as a pair will be eligible for randomization to one of the two possible masked treatment arms. The neonate-parent pair will be the unit of randomization and each parent will be allocated to the same group if both consent. After the baseline neonate testing for S. aureus colonization, repeat testing will be performed every 7 days for the neonates until the neonate acquires S. aureus colonization or is discharged from the NICU.
Interventions
DRUGPlacebo ointment and placebo cloths
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Neonate has never had a clinical or surveillance culture grow S. aureus * Neonate was transferred from another hospital or admitted from home and had admission screening cultures for S. aureus colonization that were negative (if admission cultures were not performed, the cultures will be performed as part of the pre-randomization screening process) * Parent(s) is(are) able to visit the child at the bedside * Parent(s) test positive for S. aureus at screening * Neonate has anticipated stay longer than 5 days in the NICU (if estimated stay is unclear, parents can be screened for S. aureus colonization and decision to randomize can be delayed until hospital day 3 or 4 after reassessment of anticipated stay). * Parents is(are) willing to be randomized * No documented or reported allergies to any agent used in either treatment regimen * Able to perform written informed consent
Exclusion criteria
* Allergies to any agent used in either treatment regimen * Neonate has had a prior clinical or surveillance culture grow S. aureus * Neonate admitted to NICU from home and is greater than 7 days of age * Neonate admitted to NICU from another hospital and is greater than 7 days of age * Neonate is a ward of the State * Not able to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain | Up to 90 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 147 |
| 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 | 160 |
| Total | 307 |
Baseline characteristics
| Characteristic | Placebo Ointment and Placebo Cloths | Total | Mupirocin and Chlorhexidine |
|---|---|---|---|
| Age, Continuous | 7.2 days STANDARD_DEVIATION 5.3 | 7.54 days STANDARD_DEVIATION 5.2 | 7.9 days STANDARD_DEVIATION 5.1 |
| Birthweight of neonate | 1986.9 grams STANDARD_DEVIATION 949.4 | 1984.8 grams STANDARD_DEVIATION 958.5 | 1982.5 grams STANDARD_DEVIATION 972.8 |
| Child delivery method Cesarean section | 35 Participants | 68 Participants | 33 Participants |
| Child delivery method Vaginal birth | 72 Participants | 140 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 11 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants | 181 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 16 Participants | 7 Participants |
| Gestational age at birth | 33.1 weeks STANDARD_DEVIATION 4.4 | 33 weeks STANDARD_DEVIATION 4.5 | 32.9 weeks STANDARD_DEVIATION 4.7 |
| Level of education of parent At most high school | 33 Participants | 59 Participants | 26 Participants |
| Level of education of parent Graduate degree | 38 Participants | 62 Participants | 24 Participants |
| Level of education of parent Some or completed college | 59 Participants | 130 Participants | 71 Participants |
| Level of education of parent Unknown | 30 Participants | 56 Participants | 26 Participants |
| Maternal antibiotic use during delivery | 64 Participants | 132 Participants | 68 Participants |
| Maternal Group B Streptococcus positive Negative | 43 Participants | 75 Participants | 32 Participants |
| Maternal Group B Streptococcus positive Positive | 21 Participants | 42 Participants | 21 Participants |
| Maternal Group B Streptococcus positive Unreported/Unknown | 43 Participants | 91 Participants | 48 Participants |
| Maternal HIV Positive Negative | 94 Participants | 186 Participants | 92 Participants |
| Maternal HIV Positive Positive | 2 Participants | 3 Participants | 1 Participants |
| Maternal HIV Positive Unreported/Unknown | 11 Participants | 19 Participants | 8 Participants |
| Neonate inborn or transferred in Inborn in JHH/JHBMC | 97 Participants | 188 Participants | 91 Participants |
| Neonate inborn or transferred in Transferred from another hospital to JHH/JHBMC | 8 Participants | 18 Participants | 10 Participants |
| Neonate inborn or transferred in Transferred from home to JHH/JHBMC | 2 Participants | 2 Participants | 0 Participants |
| No. of singletons | 81 Participants | 159 Participants | 78 Participants |
| Parent age at the time of enrollment | 30.9 years STANDARD_DEVIATION 7.7 | 30.6 years STANDARD_DEVIATION 6.9 | 30.3 years STANDARD_DEVIATION 5.9 |
| Parent antibiotic use in past 6 months No | 88 Participants | 161 Participants | 73 Participants |
| Parent antibiotic use in past 6 months Unreported/Unknown | 18 Participants | 33 Participants | 15 Participants |
| Parent antibiotic use in past 6 months Yes | 54 Participants | 113 Participants | 59 Participants |
| Parent history of mupirocin use No | 133 Participants | 254 Participants | 121 Participants |
| Parent history of mupirocin use Unreported/Unknown | 22 Participants | 42 Participants | 20 Participants |
| Parent history of mupirocin use Yes | 5 Participants | 11 Participants | 6 Participants |
| Parent history of Staphylococcus aureus infection No | 128 Participants | 250 Participants | 122 Participants |
| Parent history of Staphylococcus aureus infection Unreported/Unknown | 23 Participants | 42 Participants | 19 Participants |
| Parent history of Staphylococcus aureus infection Yes | 9 Participants | 15 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 14 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 57 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) White | 59 Participants | 125 Participants | 66 Participants |
| Region of Enrollment United States Johns Hopkins Bayview | 8 Participants | 16 Participants | 8 Participants |
| Region of Enrollment United States Johns Hopkins Hospital | 99 Participants | 192 Participants | 93 Participants |
| Sex: Female, Male Female | 47 Participants | 94 Participants | 47 Participants |
| Sex: Female, Male Male | 60 Participants | 114 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 147 | 0 / 160 |
| other Total, other adverse events | 9 / 147 | 16 / 160 |
| serious Total, serious adverse events | 0 / 147 | 0 / 160 |
Outcome results
Primary
Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mupirocin and Chlorhexidine | Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain | 13 neonatal S. aureus infections |
| Placebo Ointment and Placebo Cloths | Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain | 29 neonatal S. aureus infections |