Trial Outcomes & Findings for Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants (NCT NCT01827358)
NCT ID: NCT01827358
Last Updated: 2017-07-07
Results Overview
Participants were evaluated for solicited adverse events while in the NICU/ICU on days 1-7. Participants were counted if they experienced the symptom at any severity during the reporting period. Although participants received only 5 days of mupirocin, solicited events were collected through day 7.
COMPLETED
PHASE2
155 participants
Days 1 through 7
2017-07-07
Participant Flow
Infants less than 24 months of age were recruited from among those admitted to the NICU or ICU at one of the participating centers found to have a surveillance nasal swab culture positive for SA. Recruitment was performed sequentially as infants became eligible without regards for race, ethnicity, gestational age or gender.
Infants were screened for nasal SA colonization (MRSA or MSSA) and only those who were colonized (not infected) were offered enrollment.
Participant milestones
| Measure |
Mupirocin (Treatment)
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
|
No Mupirocin (Control)
Participants received no treatment or placebo
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
75
|
|
Overall Study
COMPLETED
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
35
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
Baseline characteristics by cohort
| Measure |
Mupirocin (Treatment)
n=80 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
|
No Mupirocin (Control)
n=75 Participants
Participants received no treatment or placebo
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
80 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.6 Weeks
STANDARD_DEVIATION 3.6 • n=5 Participants
|
4.8 Weeks
STANDARD_DEVIATION 4.4 • n=7 Participants
|
4.7 Weeks
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
75 participants
n=7 Participants
|
155 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.
Participants were evaluated for solicited adverse events while in the NICU/ICU on days 1-7. Participants were counted if they experienced the symptom at any severity during the reporting period. Although participants received only 5 days of mupirocin, solicited events were collected through day 7.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=78 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=77 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Fever
|
2 participants
|
1 participants
|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Rash
|
17 participants
|
4 participants
|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Swelling of nasal mucosa
|
1 participants
|
0 participants
|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Epistaxis
|
0 participants
|
0 participants
|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Diarrhea
|
9 participants
|
7 participants
|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Apnea/ bradycardia/ desaturation events
|
43 participants
|
45 participants
|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Apnea within 3-5 minutes of mupirocin application
|
8 participants
|
NA participants
Participants in the No Mupirocin (Control) group did not receive mupirocin
|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Pain within 3-5 minutes of mupirocin application
|
15 participants
|
NA participants
Participants in the No Mupirocin (Control) group did not receive mupirocin
|
|
Number of Participants With Solicited Adverse Events (AEs) During Days 1-7
Any Symptom
|
60 participants
|
65 participants
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.
Participants were evaluated for moderate and severe unsolicited adverse events (that were not otherwise considered pre-defined trial endpoints) while in the NICU/ICU on days 1-7. Although participants received 5 days of mupirocin, unsolicited events were collected until day 7. Moderate events were defined as those that may cause some interference with functioning and daily activities. Severe events were defined as those that interrupt the participant's usual daily activities and may require systemic drug therapy or other treatment. Severe events were usually incapacitating.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=78 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=77 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7
Cardiac failure
|
1 participants
Interval 0.0 to 7.0
|
0 participants
Interval 0.0 to 5.0
|
|
Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7
Heart disease congenital
|
1 participants
Interval 0.0 to 7.0
|
0 participants
Interval 0.0 to 5.0
|
|
Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7
Incarcerated inguinal hernia
|
1 participants
Interval 0.0 to 7.0
|
0 participants
Interval 0.0 to 5.0
|
|
Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7
Necrotising colitis
|
0 participants
Interval 0.0 to 5.0
|
1 participants
Interval 0.0 to 7.0
|
|
Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7
Candida infection
|
1 participants
Interval 0.0 to 7.0
|
0 participants
Interval 0.0 to 5.0
|
|
Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7
Pneumonia
|
1 participants
Interval 0.0 to 7.0
|
0 participants
Interval 0.0 to 5.0
|
|
Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7
Rhinovirus infection
|
0 participants
Interval 0.0 to 5.0
|
1 participants
Interval 0.0 to 7.0
|
PRIMARY outcome
Timeframe: Days 1 through 7Population: The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.
Participants were evaluated for Serious Adverse Events (SAEs) while in the NICU/ICU on days 1-7. Although participants received only 5 days of mupirocin, SAEs were collected through day 7. An adverse event or suspected adverse reaction was considered serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death; a life-threatening adverse event (an event that places the participant at immediate risk of death; it doesn't include an adverse event, had it occurred in a more severe form, might have caused death); inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or any other event that when based upon appropriate medical judgement may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=78 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=77 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) During Days 1-7
Staphylococcal bacteremia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) During Days 1-7
Heart disease congenital
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) During Days 1-7
Incarcerated inguinal hernia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) During Days 1-7
Infantile apnoea
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: The analysis population included all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture and who either had a complete set of NUP cultures collected on Day 8 or else had discontinued NUP cultures prior to day 8 due to a clinical SA infection.
Colonization was defined as the presence of SA identified by NUP culture without signs of illness or infection. On day 8, participants were swabbed in each of three areas: nasal, umbilical, and perianal. These swabs were cultured by direct plating. If SA did not grow on any of these cultures the infant was considered to be decolonized. If SA grew on any one of these cultures the infant was considered to be colonized with SA.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=66 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=64 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Primary Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures Obtained on Day 8.
|
62 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 8 and Day 22Population: The analysis population included all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture and who had either had complete sets of NUP cultures collected on day 8 and day 22 or else had discontinued NUP cultures prior to day 22 due to a clinical SA infection.
Participants were admitted into the study based on being colonized with SA. Participants who were decolonized both on day 8 and day 22, as determined by NUP cultures were considered to have persistent decolonization. Colonization was defined as the presence of SA identified by NUP culture without signs of illness or infection. NUP swabs were collected on day 8 and on day 22 and cultured by direct plating. If the cultures were negative for SA at both day 8 and day 22 the participant was considered to have persistent decolonization. Colonization with SA was a prerequisite for enrollment, because of this there was no baseline measure.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=46 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=48 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Persistent Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures on Days 8 and 22.
|
21 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 85Population: The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment.
Relative risk of occurrence of non-SA clinical infection in the treatment compared to the control group using the intent to treat (ITT) cohort for analysis. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the non-SA clinical infection to occur at the start of the interval, were still on study and had not yet had a non-SA clinical infection but were still being watched for the event. Non-SA clinical infection was the development of a non-SA clinical infection due to an identifiable organism as evidenced by culture of an organism other than SA from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a non-SA clinical infection but were removed from eligibility for the event at some point after the interval started.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=80 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=75 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 1-8 at risk
|
78 Participants
|
73 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 1-8 with clinical non-SA infection
|
3 Participants
|
1 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 1-8 censored
|
4 Participants
|
6 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 9-15 at risk
|
71 Participants
|
66 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 9-15 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 9-15 censored
|
11 Participants
|
12 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 16-22 at risk
|
60 Participants
|
54 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 16-22 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 16-22 censored
|
12 Participants
|
4 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 23-29 at risk
|
48 Participants
|
50 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 23-29 with clinical non-SA infection
|
0 Participants
|
3 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 23-29 censored
|
4 Participants
|
14 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 30-36 at risk
|
44 Participants
|
33 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 30-36 with clinical non-SA infection
|
1 Participants
|
1 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 30-36 censored
|
6 Participants
|
6 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 37-43 at risk
|
37 Participants
|
26 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 37-43 with clinical non-SA infection
|
1 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 37-43 censored
|
4 Participants
|
7 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 44-50 at risk
|
32 Participants
|
19 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 44-50 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 44-50 censored
|
9 Participants
|
6 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 51-57 at risk
|
23 Participants
|
13 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 51-57 with clinical non-SA infection
|
1 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 51-57 censored
|
0 Participants
|
3 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 58-64 at risk
|
22 Participants
|
10 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 58-64 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 58-64 censored
|
5 Participants
|
5 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 65-71 at risk
|
17 Participants
|
5 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 65-71 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 65-71 censored
|
6 Participants
|
1 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 72-78 at risk
|
11 Participants
|
4 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 72-78 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 72-78 censored
|
3 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 79-85 at risk
|
8 Participants
|
4 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 79-85 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort
Day 79-85 censored
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 85Population: The ATP cohort includes all infants with a site-specific pre-randomization NUP culture that is positive for SA by direct culture, those in the mupirocin treatment group must have received a minimum of 10 complete mupirocin treatments, including at least one dose to all three NUP sites per day for five consecutive days during the treatment period.
Relative risk of occurrence of non-SA clinical infection in the treatment compared to control groups using the according to protocol (ATP) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the non-SA clinical infection to occur at the start of the interval, were still on study and had not yet had a non-SA clinical infection but were still being watched for the event. Non-SA clinical infection was the development of a non-SA clinical infection due to an identifiable organism as evidenced by culture of an organism other than SA from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a non-SA clinical infection but were removed from eligibility for the event at some point after the interval started.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=67 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=66 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 1-8 at risk
|
67 Participants
|
66 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 1-8 with clinical non-SA infection
|
3 Participants
|
1 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 1-8 censored
|
3 Participants
|
4 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 9-15 at Risk
|
61 Participants
|
61 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 9-15 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 9-15 censored
|
9 Participants
|
11 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 16-22 at risk
|
52 Participants
|
50 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 16-22 with non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 16-22 censored
|
11 Participants
|
4 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 23-29 at risk
|
41 Participants
|
46 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 23-29 with clinical non-SA infection
|
0 Participants
|
3 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 23-29 censored
|
4 Participants
|
13 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 30-36 at risk
|
37 Participants
|
30 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 30-36 with clinical non-SA infection
|
1 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 30-36 censored
|
4 Participants
|
6 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 37-43 at risk
|
32 Participants
|
24 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 37-43 with clinical non-SA infection
|
1 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 37-43 censored
|
4 Participants
|
7 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 44-50 at risk
|
27 Participants
|
17 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 44-50 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 44-50 censored
|
8 Participants
|
6 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 51-57 at risk
|
19 Participants
|
11 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 51-57 with clinical non-SA infection
|
1 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 51-57 censored
|
0 Participants
|
2 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 58-64 at risk
|
18 Participants
|
9 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 58-64 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 58-64 censored
|
4 Participants
|
4 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 65-71 at risk
|
14 Participants
|
5 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 65-71 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 65-71 censored
|
5 Participants
|
1 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 72-78 at risk
|
9 Participants
|
4 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 72-78 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 72-78 censored
|
3 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 79-85 at risk
|
6 Participants
|
4 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 79-85 with clinical non-SA infection
|
0 Participants
|
0 Participants
|
|
Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.
Day 79-85 censored
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 85Population: There were no events of necrotizing enterocolitis during the study, analysis could not be performed.
Median time to occurrence of severe (stage II-III) NEC in the treatment compared to control group as estimated using Kaplan-Meier estimates of the survival curves.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 through 22Population: The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment.
Protective efficacy of clinical SA infection in the treatment compared to the control group during days 1-22 or until discharge, whichever occurs first using the intent to treat (ITT) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA clinical infection to occur at the start of the interval, were still on study and had not yet had a SA clinical infection but were still being watched for the event. SA clinical infection was the development of a SA clinical infection due to an identifiable organism as evidenced by culture of an organism from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a SA clinical infection but were removed from eligibility for the event at some point after the interval started.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=80 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=75 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 1-8 at risk
|
78 Participants
|
73 Participants
|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 1-8 with clinical SA infection
|
0 Participants
|
2 Participants
|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 1-8 censored
|
5 Participants
|
6 Participants
|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 9-15 at risk
|
73 Participants
|
65 Participants
|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 9-15 with clinical SA infection
|
1 Participants
|
1 Participants
|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 9-15 censored
|
11 Participants
|
12 Participants
|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 16-22 at risk
|
61 Participants
|
52 Participants
|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 16-22 with clinical SA infection
|
0 Participants
|
1 Participants
|
|
Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.
Day 16-22 censored
|
61 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 22Population: The ATP cohort includes all infants that have met all requirements of the mITT cohort, with the further requirements that infants in the mupirocin treatment group must have received a minimum of 10 complete mupirocin treatments, including at least one dose to all three NUP sites per day for five consecutive days during the treatment period.
Protective efficacy of clinical SA infection in the treatment compared to the control group during days 1-22 or until discharge, whichever occurs first using the ATP cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA clinical infection to occur at the start of the interval, were still on study and had not yet had a SA clinical infection but were still being watched for the event. SA clinical infection was the development of a SA clinical infection due to an identifiable organism as evidenced by culture of an organism from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a SA clinical infection but were removed from eligibility for the event at some point after the interval started.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=67 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=66 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 1-8 at risk
|
67 Participants
|
66 Participants
|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 1-8 with clinical SA infection
|
0 Participants
|
2 Participants
|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 1-8 censored
|
4 Participants
|
4 Participants
|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 9-15 at risk
|
63 Participants
|
60 Participants
|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 9-15 with clinical SA infection
|
1 Participants
|
1 Participants
|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 9-15 censored
|
9 Participants
|
11 Participants
|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 16-22 at risk
|
53 Participants
|
48 Participants
|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 16-22 with clinical SA infection
|
0 Participants
|
1 Participants
|
|
Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.
Day 16-22 censored
|
53 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 85Population: Clinical infection besides SA infection on or prior to Day 85 was not observed frequently enough to allow estimation of the median time to infection using non-parametric methods.
Median time to occurrence of non-SA clinical infection in the treatment compared to control group as estimated using Kaplan-Meier estimates of the survival curves.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 through 85Population: There were no events of necrotizing enterocolitis during the study, analysis could not be performed.
The association between mupirocin treatment and severe (stage II-III) NEC on or before Day 85 was to be assessed via Cox Proportional Hazards Model.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 through 85Population: The mITT cohort includes all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture. The mITT-8 cohort includes all mITT infants who either had a complete set of NUP cultures collected on day 8 or else had discontinuation of NUP cultures prior to Day 8 due to a clinical SA infection.
Time until decolonization: Count of participants from Day 1 until the first NUP collection with no SA is detected in the nares, umbilical, and perianal areas using the modified intent to treat (mITT-8) cohort. The time periods in the table correspond to the study days having collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA decolonization to occur at the start of the interval, were still on study and had not yet had SA decolonization but were still being watched for the event. SA decolonization was the absence of SA detected from the NUP cultures through direct plating. Censored participants were at risk for some of the interval, did not have SA decolonization but were removed from eligibility for the event at some point after the interval started.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=66 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=64 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 1-8 at risk
|
66 Participants
|
64 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 1-8 with decolonization
|
59 Participants
|
3 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 1-8 censored
|
1 Participants
|
14 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 9-15 at risk
|
6 Participants
|
47 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 9-15 with decolonization
|
3 Participants
|
0 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 9-15 censored
|
0 Participants
|
4 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 16-22 at risk
|
3 Participants
|
43 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 16-22 with decolonization
|
0 Participants
|
0 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).
Day 16-22 censored
|
3 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 85Population: The ATP-8 cohort includes all ATP infants who had a set of NUP cultures collected on Day 8 (± 2).
Time until decolonization: Count of participants from Day 1 until the first NUP collection with no SA is detected in the nares, umbilical, and perianal areas using the according to protocol day 8 (ATP-8) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA decolonization to occur at the start of the interval, were still on study and had not yet had SA decolonization but were still being watched for the event. SA decolonization was the absence of SA detected from the NUP cultures through direct plating. Censored participants were at risk for some of the interval, did not have SA decolonization but were removed from eligibility for the event at some point after the interval started.
Outcome measures
| Measure |
Mupirocin (Treatment)
n=64 Participants
Participants received a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses.
|
No Mupirocin (Control)
n=63 Participants
Participants received no treatment and no placebo.
|
|---|---|---|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 1-8 at risk
|
64 Participants
|
63 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 1-8 with decolonization
|
57 Participants
|
2 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 1-8 censored
|
1 Participants
|
14 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 9-15 at risk
|
6 Participants
|
47 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 9-15 with decolonization
|
3 Participants
|
0 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 9-15 censored
|
0 Participants
|
4 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 16-22 at risk
|
3 Participants
|
43 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 16-22 with decolonization
|
0 Participants
|
0 Participants
|
|
Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.
Day 16-22 censored
|
3 Participants
|
43 Participants
|
Adverse Events
Mupirocin (Treatment)
No Mupirocin (Control)
Serious adverse events
| Measure |
Mupirocin (Treatment)
n=78 participants at risk；n=80 participants at risk
Participants receive a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
|
No Mupirocin (Control)
n=77 participants at risk；n=75 participants at risk
Participants received no treatment and no placebo.
|
|---|---|---|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.2%
1/80 • Number of events 1 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
0.00%
0/75 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
1.2%
1/80 • Number of events 1 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
0.00%
0/75 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
1.2%
1/80 • Number of events 1 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
0.00%
0/75 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoea
|
1.2%
1/80 • Number of events 1 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
0.00%
0/75 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
Other adverse events
| Measure |
Mupirocin (Treatment)
n=78 participants at risk；n=80 participants at risk
Participants receive a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
|
No Mupirocin (Control)
n=77 participants at risk；n=75 participants at risk
Participants received no treatment and no placebo.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
21.8%
17/78 • Number of events 52 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
5.2%
4/77 • Number of events 12 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
9/78 • Number of events 18 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
9.1%
7/77 • Number of events 14 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
55.1%
43/78 • Number of events 128 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
58.4%
45/77 • Number of events 129 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
10.3%
8/78 • Number of events 9 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
—
0/0 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
|
General disorders
Application site pain
|
19.2%
15/78 • Number of events 18 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
—
0/0 • Adverse events were collected on days 1-7.
For days 1-7, study staff were responsible for identifying solicited adverse events (AEs), unsolicited moderate and severe AEs and serious adverse events (SAEs) on a daily basis. Solicited adverse events of apnea within 3-5 minutes of mupirocin application and pain within 3-5 minutes of mupirocin application, were not applicable to the control group since they did not receive mupirocin.
|
Additional Information
Karen Kotloff, MD
University of Maryland Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60