An interventional study of Mupirocin and Chlorhexidine and Placebo ointment and placebo cloths in Staph Aureus Colonization and Staph Aureus Infection, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
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.
273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.
This study's enrollment of 307 is above the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.
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Exclusion Criteria:
Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.
Drug: Mupirocin and Chlorhexidine
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.
Drug: Placebo ointment and placebo cloths
Also known as: bactroban, chlorhexidine gluconate
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
| Milestone | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths |
|---|---|---|
| Started | 147 | 160 |
| Completed | 147 | 160 |
| Not completed | 0 | 0 |
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.
| neonatal S. aureus infections | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths |
|---|---|---|
| Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain | 13 | 29 |
Collected over During the 5 days of treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mupirocin and Chlorhexidine | 0/147 (0%) | 0/147 (0%) | 9/147 (6.1%) |
| Placebo Ointment and Placebo Cloths | 0/160 (0%) | 0/160 (0%) | 16/160 (10%) |
| Event | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths |
|---|---|---|
| Skin irritationSkin and subcutaneous tissue disorders | 7/147 | 10/160 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 1/147 | 5/160 |
| Nose irritationRespiratory, thoracic and mediastinal disorders | 1/147 | 0/160 |
| Retained placentaPregnancy, puerperium and perinatal conditions | 0/147 | 1/160 |
| Age, Continuous(days) | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths | Total |
|---|---|---|---|
| Mean | 7.9 ± 5.1 | 7.2 ± 5.3 | 7.54 ± 5.2 |
| Sex: Female, Male(Participants) | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths | Total |
|---|---|---|---|
| Female | 47 | 47 | 94 |
| Male | 54 | 60 | 114 |
| Ethnicity (NIH/OMB)(Participants) | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 3 | 11 |
| Not Hispanic or Latino | 86 | 95 | 181 |
| Unknown or Not Reported | 7 | 9 | 16 |
| Race (NIH/OMB)(Participants) | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 11 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 27 | 30 | 57 |
| White | 66 | 59 | 125 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 7 | 12 |
| Region of Enrollment(Participants) | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths | Total |
|---|---|---|---|
| United States — Johns Hopkins Hospital | 93 | 99 | 192 |
| United States — Johns Hopkins Bayview | 8 | 8 | 16 |
| Parent age at the time of enrollment(years) | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths | Total |
|---|---|---|---|
| Mean | 30.3 ± 5.9 | 30.9 ± 7.7 | 30.6 ± 6.9 |
| Parent antibiotic use in past 6 months(Participants) | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths | Total |
|---|---|---|---|
| Yes | 59 | 54 | 113 |
| No | 73 | 88 | 161 |
| Unreported/Unknown | 15 | 18 | 33 |
| Parent history of mupirocin use(Participants) | Mupirocin and Chlorhexidine | Placebo Ointment and Placebo Cloths | Total |
|---|---|---|---|
| Yes | 6 | 5 | 11 |
| No | 121 | 133 | 254 |
| Unreported/Unknown | 20 | 22 | 42 |
10 further baseline measures are reported on the registry.
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