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Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis

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ClinicalTrials.gov Identifier: NCT00462020
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : January 16, 2012
Last Update Posted : January 16, 2012
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Perforated Appendicitis
Interventions Drug: 5 days of IV antibiotics (ceftriaxone and metronidazole)
Drug: Home with oral antibiotics when eating (ampicillin/clavulanic acid)
Enrollment 150

Recruitment Details All patients with perforated appendicitis were recruited for this study.
Pre-assignment Details  
Arm/Group Title IV Only IV and Oral Abx
Hide Arm/Group Description 5 days of IV antibiotics after appendectomy home on oral antibiotics to complete 7 days of treatment when tolerating PO's
Period Title: Overall Study
Started 52 50
Completed 52 50
Not Completed 0 0
Arm/Group Title IV Only IV and Oral Abx Total
Hide Arm/Group Description 5 days of IV antibiotics after appendectomy home on oral antibiotics to complete 7 days of treatment when tolerating PO's Total of all reporting groups
Overall Number of Baseline Participants 52 50 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 102 participants
<=18 years
52
 100.0%
50
 100.0%
102
 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%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 50 participants 102 participants
9.7  (4.2) 10.1  (4.6) 9.9  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 102 participants
Female
20
  38.5%
23
  46.0%
43
  42.2%
Male
32
  61.5%
27
  54.0%
59
  57.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 50 participants 102 participants
52 50 102
1.Primary Outcome
Title Abscess After Appendectomy
Hide Description [Not Specified]
Time Frame 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Only IV and Oral Abx
Hide Arm/Group Description:
5 days of IV antibiotics after appendectomy
home on oral antibiotics to complete 7 days of treatment when tolerating PO's
Overall Number of Participants Analyzed 52 50
Measure Type: Number
Unit of Measure: number of patients
10 10
2.Secondary Outcome
Title Length of Stay, Charges, Adverse Events
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Only IV and Oral Abx
Hide Arm/Group Description 5 days of IV antibiotics after appendectomy home on oral antibiotics to complete 7 days of treatment when tolerating PO's
All-Cause Mortality
IV Only IV and Oral Abx
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Only IV and Oral Abx
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Only IV and Oral Abx
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Shawn D. St. Peter, MD
Organization: Children's Mercy Hospital
Phone: 816-983-6479
Responsible Party: Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00462020     History of Changes
Other Study ID Numbers: 07 02 031
First Submitted: April 16, 2007
First Posted: April 18, 2007
Results First Submitted: December 12, 2011
Results First Posted: January 16, 2012
Last Update Posted: January 16, 2012