Abscess, Skin Disease, Bacterial
Conditions
Keywords
Methicillin resistent Staphylococcus aureus, Staphylococcus aureus
Brief summary
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.
Detailed description
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).
Interventions
DRUGTrimethoprim-Sulfamethoxazole
3 versus 10 days of drug
Sponsors
New York State Department of Health
Women & Children's Hospital of Buffalo
Lucy Holmes, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter) * minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient
Exclusion criteria
* patients requiring immediate hospitalization * patients who have received 2 or more doses of antibiotics in the previous 36 hours * patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices * patients with a concurrent, non-abscess infection * patients with an allergy to Trimethoprim-sulfamethoxazole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failures | up to 2 weeks after surgical drainage | 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. |
| Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | up to 2 weeks after surgical drainage | 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. |
| Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | up to 2 weeks after surgical drainage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Skin Infections | 1 month after surgical drainage | 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. |
| Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | 1 month after surgical drainage | 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. |
| Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | 1 month after surgical drainage | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3 Days Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day | 125 |
| 10 Days Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day | 124 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
| Overall Study | Protocol Violation | 3 | 3 |
Baseline characteristics
| Characteristic | 3 Days | 10 Days | Total |
|---|---|---|---|
| Abscess location Abscess above the waist | 37 participants | 30 participants | 67 participants |
| Abscess location Abscess below the waist | 87 participants | 91 participants | 178 participants |
| Abscess location Abscess both locations | 1 participants | 3 participants | 4 participants |
| Abscess size | 6.25 cm2 | 6.25 cm2 | 6.25 cm2 |
| Age, Continuous | 4.5 years | 3.42 years | 4.08 years |
| Clindamycin administered in ED No | 113 participants | 95 participants | 208 participants |
| Clindamycin administered in ED Yes | 12 participants | 29 participants | 41 participants |
| Culture results MRSA | 69 participants | 69 participants | 138 participants |
| Culture results MSSA | 39 participants | 40 participants | 79 participants |
| Culture results No Growth | 3 participants | 1 participants | 4 participants |
| Culture results Other | 14 participants | 14 participants | 28 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 17 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 107 Participants | 208 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of abscess No | 75 participants | 82 participants | 157 participants |
| History of abscess Yes | 50 participants | 42 participants | 92 participants |
| History of household contact with abscess No | 63 participants | 61 participants | 124 participants |
| History of household contact with abscess Yes | 62 participants | 63 participants | 125 participants |
| Presence of ≥ 2 Abscesses No | 114 participants | 117 participants | 231 participants |
| Presence of ≥ 2 Abscesses Yes | 11 participants | 7 participants | 18 participants |
| presence of cellulitis cellulitis | 22 participants | 38 participants | 60 participants |
| presence of cellulitis no cellulitis | 103 participants | 86 participants | 189 participants |
| presence of fever fever | 11 participants | 11 participants | 22 participants |
| presence of fever no fever | 114 participants | 113 participants | 227 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants | 59 Participants | 122 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 55 Participants | 104 Participants |
| Sex: Female, Male Female | 83 Participants | 74 Participants | 157 Participants |
| Sex: Female, Male Male | 42 Participants | 50 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 125 | 0 / 124 |
| serious Total, serious adverse events | 0 / 125 | 0 / 124 |
Outcome results
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.
Time frame: up to 2 weeks after surgical drainage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Days | Treatment Failures | 9 participants |
| 10 Days | Treatment Failures | 4 participants |
p-value: 0.2595% CI: [-1.5, 9.5]Chi-squared
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.
Time frame: up to 2 weeks after surgical drainage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Days | Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | 8 participants |
| 10 Days | Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | 1 participants |
p-value: 0.0395% CI: [2.1, 18.2]Chi-squared
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.
Time frame: up to 2 weeks after surgical drainage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Days | Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | 1 participants |
| 10 Days | Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | 1 participants |
p-value: >0.0595% CI: [-6.9, 7]Chi-squared
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.
Time frame: 1 month after surgical drainage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Days | Recurrent Skin Infections | 21 participants |
| 10 Days | Recurrent Skin Infections | 9 participants |
p-value: 0.0295% CI: [2.1, 19.2]Chi-squared
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.
Time frame: 1 month after surgical drainage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Days | Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | 8 participants |
| 10 Days | Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | 2 participants |
p-value: 0.04695% CI: [0.8, 19.9]Chi-squared
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.
Time frame: 1 month after surgical drainage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 Days | Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | 7 participants |
| 10 Days | Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | 7 participants |
p-value: >0.05Chi-squared