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| Name | Class |
|---|---|
| New York State Department of Health | OTHER_GOV |
| Women & Children's Hospital of Buffalo | OTHER |
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The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.
Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 days of Trimethoprim-Sulfamethoxazole | Active Comparator | Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
|
| 3 days of Trimethoprim-Sulfamethoxazole | Experimental | Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimethoprim-Sulfamethoxazole | Drug | 3 versus 10 days of drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failures | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | up to 2 weeks after surgical drainage |
| Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | up to 2 weeks after surgical drainage |
| Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | up to 2 weeks after surgical drainage |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Skin Infections | Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. | 1 month after surgical drainage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy C Holmes, MD | University at Buffalo | Principal Investigator |
| Howard Faden, MD | University at Buffalo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Children's Hospital of Buffalo | Buffalo | New York | 14222 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19409657 | Background | Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5. | |
| 20346539 | Background | Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 Days | Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
| FG001 | 10 Days | Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 Days | Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
| BG001 | 10 Days | Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Failures | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | Posted | Number | participants | up to 2 weeks after surgical drainage |
|
2.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 Days | Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucy Holmes | University at Buffalo | 716-878-7277 | LHolmes@upa.chob.edu |
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| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D000038 | Abscess |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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| Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus |
Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. |
| 1 month after surgical drainage |
| Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. | 1 month after surgical drainage |
| 26578074 | Derived | Holmes L, Ma C, Qiao H, Drabik C, Hurley C, Jones D, Judkiewicz S, Faden H. Trimethoprim-Sulfamethoxazole Therapy Reduces Failure and Recurrence in Methicillin-Resistant Staphylococcus aureus Skin Abscesses after Surgical Drainage. J Pediatr. 2016 Feb;169:128-34.e1. doi: 10.1016/j.jpeds.2015.10.044. Epub 2015 Nov 11. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Abscess location | Number | participants |
|
| presence of fever | Number | participants |
|
| presence of cellulitis | Number | participants |
|
| Clindamycin administered in ED | Number | participants |
|
| History of abscess | Number | participants |
|
| History of household contact with abscess | Number | participants |
|
| Presence of ≥ 2 Abscesses | Number | participants |
|
| Abscess size | Median | Inter-Quartile Range | cm2 |
|
| Culture results | Number | participants |
|
|
|
|
| Secondary | Recurrent Skin Infections | Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. | Posted | Number | participants | 1 month after surgical drainage |
|
|
|
|
| Primary | Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | Posted | Number | participants | up to 2 weeks after surgical drainage |
|
|
|
|
| Primary | Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | Posted | Number | participants | up to 2 weeks after surgical drainage |
|
|
|
|
| Secondary | Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. | Posted | Number | participants | 1 month after surgical drainage |
|
|
|
|
| Secondary | Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. | Posted | Number | participants | 1 month after surgical drainage |
|
|
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| EG001 | 10 Days | Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day | 0 | 124 | 0 | 124 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |