Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-03-08 @ 4:49 AM
Study NCT ID:
NCT02127658
Status:
TERMINATED
Last Update Posted:
2024-06-25
First Post:
2014-04-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MRSA Eradication and Decolonization in Children
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
MRSA Eradication and Decolonization in Children
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit all planned participants prior to end of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDiC
Brief Summary:
In this study, the investigators intend to compare therapies (abscess surgery and hygiene education compared to abscess surgery and hygiene education followed by decolonization) for Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to determine which is the more effective treatment. The investigators focus on patient centered outcomes as described by the families of MRSA infected patients. Such outcomes are likely to include quality of life, side effects, and school and work attendance. The hypothesis is that treatment with decolonization will decrease the rate of SSTI recurrence and improve overall patient centered outcomes. The rationale is that negative outcomes such as recurrence may be avoided through the use of readily available prevention strategies, but that it is important to determine how burdensome those prevention strategies are for patients and families.
Detailed Description:
The past two decades have seen a dramatic increase in skin and soft tissue infections (SSTI) caused by antibiotic resistant bacteria Methicillin-resistant Staphylococcus aureus (MRSA). The shift from hospital-acquired infections to community-acquired infections has resulted in many otherwise healthy children being affected. Recent estimates are that the US incidence of hospitalizations caused by MRSA SSTI is \> 45 per 100,000 children, with many children requiring surgical procedures to drain pus caused by the infection.
Treatment of MRSA SSTI usually involves abscess surgery (incision and drainage), but recurrence of infection can be as high as 72%. Decolonization protocols are, therefore, sometimes recommended to eradicate the bacteria and decrease recurrence. These measures can be burdensome for the patient, consisting of regular bleach baths or chlorhexidine body washes, and/or daily nasal antibiotics. The Infectious Disease Society of America supports decolonization, but acknowledges that the recommendations are based on limited, non-MRSA specific data. One small, randomized controlled trial of children with Staphylococcus aureus infection (MRSA and non MRSA) has shown a short lasting effect (4 months) on skin colonization (presence of bacteria on the skin), and an even shorter lasting effect (1 month) on SSTI recurrence. The effect of decolonization on patient-centered outcomes such as quality of life and school attendance has not been assessed.
In this study, the investigators intend to compare therapies (abscess surgery and hygiene education compared to abscess surgery and hygiene education followed by decolonization) for Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to determine which is the more effective treatment. The investigators focus on patient centered outcomes as described by the families of MRSA infected patients. Such outcomes are likely to include quality of life, side effects, and school and work attendance. The hypothesis is that treatment with decolonization will decrease the rate of SSTI recurrence and improve overall patient centered outcomes. The rationale is that negative outcomes such as recurrence may be avoided through the use of readily available prevention strategies, but that it is important to determine how burdensome those prevention strategies are for patients and families.
Treatment of MRSA SSTI usually involves abscess surgery (incision and drainage), but recurrence of infection can be as high as 72%. Decolonization protocols are, therefore, sometimes recommended to eradicate the bacteria and decrease recurrence. These measures can be burdensome for the patient, consisting of regular bleach baths or chlorhexidine body washes, and/or daily nasal antibiotics. The Infectious Disease Society of America supports decolonization, but acknowledges that the recommendations are based on limited, non-MRSA specific data. One small, randomized controlled trial of children with Staphylococcus aureus infection (MRSA and non MRSA) has shown a short lasting effect (4 months) on skin colonization (presence of bacteria on the skin), and an even shorter lasting effect (1 month) on SSTI recurrence. The effect of decolonization on patient-centered outcomes such as quality of life and school attendance has not been assessed.
In this study, the investigators intend to compare therapies (abscess surgery and hygiene education compared to abscess surgery and hygiene education followed by decolonization) for Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to determine which is the more effective treatment. The investigators focus on patient centered outcomes as described by the families of MRSA infected patients. Such outcomes are likely to include quality of life, side effects, and school and work attendance. The hypothesis is that treatment with decolonization will decrease the rate of SSTI recurrence and improve overall patient centered outcomes. The rationale is that negative outcomes such as recurrence may be avoided through the use of readily available prevention strategies, but that it is important to determine how burdensome those prevention strategies are for patients and families.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R24HS022434-01 | NIH | None | https://reporter.nih.gov/quic… | View |