Abscess, Folliculitis, Staphylococcal Infection, Staphylococcal Skin Infection
Conditions
Keywords
clinical trial, randomized, blinded, controlled
Brief summary
The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA). The investigators hypothesize that treatment with cephalexin, a penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is most often susceptible.
Detailed description
Community-associated methicillin resistant Staphylococcus Aureus (CA-MRSA) infections have increased significantly over the past decade. Nearly every major region of the country has reported infections with this organism, with some areas reporting a prevalence as high as 80%. Epidemiologic evidence points to the emergence of a new strain of MRSA within the community, with unique genetic and clinical characteristics that differentiate it from traditional hospital-associated MRSA (HA-MRSA). Unlike HA-MRSA, these CA-MRSA are often susceptible in vitro to multiple antibiotic classes (other than penicillins and cephalosporins), and often cause significant, deep-seated abscesses in healthy individuals without any known risk factors for healthcare contact. Prior to awareness of this disease, many clinicians were using penicillin and cephalosporin antibiotics for empiric treatment of cutaneous abscesses, yet widespread treatment failures in the face of increasing CA-MRSA infections did NOT occur. During a one-year retrospective study in pediatric patients at our institution, we found that nearly 50% of CA-MRSA abscesses were treated with inappropriate antibiotics by susceptibility profiles without any significant adverse outcomes. Many clinicians are now confronted with the dilemma of whether to change empiric antibiotic therapy to other classes to which CA-MRSA would be expected to be susceptible; the most common choices including clindamycin, trimethoprim-sulfamethoxazole (TMP-SMX), or vancomycin. Unfortunately, each of these antibiotics has problems of its own in terms of increased cost, poor palatability of pediatric liquid formulation, poorer side effect profile, or necessity of IV infusion, and at this time the optimal, empiric antibiotic treatment for presumed CA-MRSA skin and soft tissue infections is unclear. The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by CA-MRSA. We hypothesize that treatment with cephalexin, a penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is most often susceptible.
Interventions
DRUGcephalexin
cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
DRUGclindamycin
clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days
Sponsors
Thrasher Research Fund
Johns Hopkins University
Aaron Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Children between the ages of 6 months and 18 years of age (inclusive) * Suspected purulent staphylococcal skin or soft tissue infection * No hospitalization within the previous 14 days * Must have reliable means of follow-up contact (e.g. working phone) * Outpatient management in the judgement of treating physician
Exclusion criteria
* Hospitalization on initial visit * Voluntary withdrawal by the treating physician in order to dictate the antibiotic being used * Patients with a history of hypersensitivity to or intolerance of cephalexin (or other beta lactams) or clindamycin. * Patients with altered immunity (inherited or acquired) * Patients with skin infections related to surgical wounds or hardware. * Patients currently on antibiotic therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement at the 48-72 Hour Clinical Follow-up | 48-72 hour clinical follow-up | Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 cephalexin arm | 100 |
| Group 2 clindamycin arm | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 100 Participants | 100 Participants | 200 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 55 Participants | 60 Participants | 115 Participants |
| Sex: Female, Male Male | 45 Participants | 40 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Clinical Improvement at the 48-72 Hour Clinical Follow-up
Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement.
Time frame: 48-72 hour clinical follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cephalexin | Clinical Improvement at the 48-72 Hour Clinical Follow-up | 94 participants |
| Clindamycin | Clinical Improvement at the 48-72 Hour Clinical Follow-up | 97 participants |