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Trial record 45 of 231 for:    clindamycin

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

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ClinicalTrials.gov Identifier: NCT00352612
Recruitment Status : Completed
First Posted : July 14, 2006
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Collaborators:
Thrasher Research Fund
Johns Hopkins University
Information provided by (Responsible Party):
Aaron Chen, Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Staphylococcal Infection
Abscess
Staphylococcal Skin Infection
Folliculitis
Interventions Drug: clindamycin
Drug: cephalexin
Enrollment 200
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cephalexin Clindamycin
Hide Arm/Group Description patients who received cephalexin those who received clindamycin
Period Title: Overall Study
Started 100 100
Completed 100 100
Not Completed 0 0
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description cephalexin arm clindamycin arm Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
<=18 years
100
 100.0%
100
 100.0%
200
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
55
  55.0%
60
  60.0%
115
  57.5%
Male
45
  45.0%
40
  40.0%
85
  42.5%
1.Primary Outcome
Title Clinical Improvement at the 48-72 Hour Clinical Follow-up
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cephalexin Clindamycin
Hide Arm/Group Description:
those patients who received cephalexin
those patients who received clindamycin
Overall Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
94 97
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cephalexin Clindamycin
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Cephalexin Clindamycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cephalexin Clindamycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cephalexin Clindamycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aaron Chen
Organization: Johns Hopkins University
Phone: 4109556143
EMail: achen33@jhmi.edu
Layout table for additonal information
Responsible Party: Aaron Chen, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00352612     History of Changes
Other Study ID Numbers: NA_00003301
First Submitted: July 13, 2006
First Posted: July 14, 2006
Results First Submitted: April 10, 2012
Results First Posted: May 13, 2013
Last Update Posted: May 13, 2013