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NCT01141101 · ClinicalTrials.gov registry record

Risk Factors for Early Infant Colonization With Methicillin-Resistant Staphylococcus Aureus

A clinical trial of Methicillin-resistant Staphylococcus Aureus, sponsored by Boston Medical Center.

Completed
Registry status
100
Enrollment target
1
Study location

NCT01141101 is a study of Methicillin-resistant Staphylococcus Aureus that has completed, run by Boston Medical Center. The registered enrollment target is 100 participants, below the 15,885-participant average among 5 other Methicillin-resistant Staphylococcus Aureus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01141101, a study of Methicillin-resistant Staphylococcus Aureus, has completed, sponsored by Boston Medical Center.

COMPLETED
Registry status
100 participants
Enrollment target
1
Study location

Study Summary

The prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) colonization and infections have been increasing in the general population, including the pediatric population. It has been reported that MRSA colonization persists for up to four years, and therefore the youngest pediatric patients, specifically those who are less than 2 years of age, have a high risk of prolonged colonization during a period of time when they are susceptible to significant skin and soft tissue infections (SSTIs) attributable to MRSA. Once prolonged colonization takes place, recurrent SSTIs are commonplace, resulting in substantial morbidity and in some cases mortality, as well as a significant cost to the healthcare system. Individuals colonized with MRSA have an increased risk of developing MRSA infections, which range from mild disease, such as carbuncles, to severe infections, such as necrotizing pneumonia and toxic shock syndrome. The prevalence of severe MRSA infections is also greatest in neonates and infants, where increased MRSA colonization has been observed. In the early infant period, the most common manifestation of MRSA disease is pustular skin lesions, which affect approximately 5% of the general population, with MRSA-colonization being a major risk factor for this disease. Moreover, the prevalence of pustular disease is increasing in the general population, and there are numerous case reports of invasive, life-threatening MRSA disease in the early infant period. Corresponding to the increasing prevalence in the community, the carriage of MRSA in pregnant women has also escalated, and vaginal carriage is significant in pregnant women. As an analogy, maternal vaginal Group B Streptococcal (GBS) colonization is the major risk for infant colonization regardless of whether early or late neonatal colonization or disease occurs. It is quite feasible that vaginal MRSA carriage predisposes newborns to colonization during the birthing process; however, this mechanism has no

Study Locations (1)

Massachusetts

  • Boston Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2010-06
Est. Completion 2012-06

Sponsor

Boston Medical Center

253 total trials

What the Registry Record Tells You About NCT01141101

The ClinicalTrials.gov registry entry for NCT01141101 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 15,885-participant average among 5 other Methicillin-resistant Staphylococcus Aureus trials with a reported enrollment target (99% lower). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Methicillin-resistant Staphylococcus Aureus appearing as the primary indexed condition, and to 0 interventions.

NCT01141101 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01141101 about?

NCT01141101 is a clinical study titled "Risk Factors for Early Infant Colonization With Methicillin-Resistant Staphylococcus Aureus". The prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) colonization and infections have been increasing in the general population, including the pediatric population. It has been reported that MRSA colonization persists for up to four years, and therefore the youngest pediatric patient...

What is the current status of trial NCT01141101?

This trial is currently completed. The enrollment target is 100 participants. The study started on 2010-06. Estimated completion is 2012-06.

What conditions does trial NCT01141101 study?

This clinical trial studies the following conditions: Methicillin-resistant Staphylococcus Aureus.

Who is sponsoring clinical trial NCT01141101?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01141101 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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