Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections

NCT00352612 | Completed Phase 4 Results DMC

• 1 other identifier: NA_00003301
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcal Infection; Abscess; Staphylococcal Skin Infection; Folliculitis

Keywords

clinical trial; randomized; blinded; controlled

Outcome Measures

Primary Outcomes (1)

• 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.

  48-72 hour clinical follow-up

Study Arms (2)

cephalexin

PLACEBO COMPARATOR

Drug: cephalexin

clindamycin

ACTIVE COMPARATOR

Drug: clindamycin

Interventions

clindamycin DRUG

clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days

clindamycin

cephalexin DRUG

cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days

Also known as: keflex

cephalexin

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aaron Chen: lead
• Thrasher Research Fund: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections; Abscess; Staphylococcal Skin Infections; Folliculitis

Interventions

Clindamycin; Cephalexin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Hair Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Aaron Chen
• Organization: Johns Hopkins University

achen33@jhmi.edu

4109556143

Study Officials

• Aaron E Chen, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Study Start: September 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 13, 2013
• Results First Posted: May 13, 2013

Record last verified: 2013-04

Locations

US (1)