Trial · NCT01827358
Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
NCT01827358, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2017-07-07
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ConductScience Library. Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants. Trials, record NCT01827358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01827358
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
- NCT number
- NCT01827358
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Staphylococcal Infection
- Interventions
- Mupirocin calcium, Mupirocin calcium
- First posted
- 2013-04-09
- Last updated
- 2017-07-07
- Results first posted
- 2017-07-07
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | Days 1 through 7 | 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. |
| Primary | Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7 | Days 1 through 7 | 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. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) During Days 1-7 | Days 1 through 7 | 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. |
| Primary | 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. | Day 8 | 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. |
| Primary | 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. | Day 8 and Day 22 | 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. |
| Secondary | Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort | Day 1 through 85 | 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. |
| Secondary | Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort. | Day 1 through 85 | 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. |
| Secondary | Median Time to Occurrence of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group. | Day 1 through 85 | 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. |
| Secondary | 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 through 22 | 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. |
| Secondary | 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 through 22 | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | Days 1 through 7 | 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 | NUMBER |
| PRIMARY | Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7 | Days 1 through 7 | 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 | NUMBER |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) During Days 1-7 | Days 1 through 7 | 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 | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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. | Day 8 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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. | Day 8 and Day 22 | 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 | COUNT_OF_PARTICIPANTS |
| SECONDARY | Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort | Day 1 through 85 | The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort. | Day 1 through 85 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to Occurrence of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group. | Day 1 through 85 | There were no events of necrotizing enterocolitis during the study, analysis could not be performed. | ||
| SECONDARY | 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 through 22 | The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 through 22 | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group260
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | Mupirocin (Treatment) | Fever | 2 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | No Mupirocin (Control) | Fever | 1 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | Mupirocin (Treatment) | Rash | 17 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | No Mupirocin (Control) | Rash | 4 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | Mupirocin (Treatment) | Swelling of nasal mucosa | 1 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | No Mupirocin (Control) | Swelling of nasal mucosa | 0 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | Mupirocin (Treatment) | Epistaxis | 0 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | No Mupirocin (Control) | Epistaxis | 0 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | Mupirocin (Treatment) | Diarrhea | 9 | participants | |
| Number of Participants With Solicited Adverse Events (AEs) During Days 1-7 | No Mupirocin (Control) | Diarrhea | 7 | participants |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mupirocin (Treatment) | 80 | |
| Overall Study | STARTED | No Mupirocin (Control) | 75 | |
| Overall Study | COMPLETED | Mupirocin (Treatment) | 45 | |
| Overall Study | COMPLETED | No Mupirocin (Control) | 44 | |
| Overall Study | NOT COMPLETED | Mupirocin (Treatment) | 35 | |
| Overall Study | NOT COMPLETED | No Mupirocin (Control) | 31 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Mupirocin (Treatment) | 17 | 78 | 52 |
| other | Rash | Skin and subcutaneous tissue disorders | No Mupirocin (Control) | 4 | 77 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | Mupirocin (Treatment) | 9 | 78 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | No Mupirocin (Control) | 7 | 77 | 14 |
| other | Apnea | Respiratory, thoracic and mediastinal disorders | Mupirocin (Treatment) | 43 | 78 | 128 |
| other | Apnea | Respiratory, thoracic and mediastinal disorders | No Mupirocin (Control) | 45 | 77 | 129 |
| other | Administration related reaction | Injury, poisoning and procedural complications | Mupirocin (Treatment) | 8 | 78 | 9 |
| other | Administration related reaction | Injury, poisoning and procedural complications | No Mupirocin (Control) | 0 | 0 | 0 |
| other | Application site pain | General disorders | Mupirocin (Treatment) | 15 | 78 | 18 |
| other | Application site pain | General disorders | No Mupirocin (Control) | 0 | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mupirocin (Treatment) | ||
| Total, all-cause mortality | No Mupirocin (Control) | ||
| Total, other adverse events | Mupirocin (Treatment) | 60 | 78 |
| Total, other adverse events | No Mupirocin (Control) | 50 | 77 |
| Total, serious adverse events | Mupirocin (Treatment) | 3 | 80 |
| Total, serious adverse events | No Mupirocin (Control) | 0 | 75 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30587533 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Mupirocin (Treatment) vs No Mupirocin (Control): 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. | Trial comparisons |
Mupirocin (Treatment) vs No Mupirocin (Control): 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. | Trial comparisons |
| Mupirocin (Treatment) vs No Mupirocin (Control): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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