Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00462020
First received: April 16, 2007
Last updated: December 12, 2011
Last verified: December 2011
Results First Received: December 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients with perforated appendicitis were recruited for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none

Reporting Groups
  Description
IV Only 5 days of IV antibiotics after appendectomy
IV and Oral Abx home on oral antibiotics to complete 7 days of treatment when tolerating PO's

Participant Flow:   Overall Study
    IV Only     IV and Oral Abx  
STARTED     52     50  
COMPLETED     52     50  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IV Only 5 days of IV antibiotics after appendectomy
IV and Oral Abx home on oral antibiotics to complete 7 days of treatment when tolerating PO's
Total Total of all reporting groups

Baseline Measures
    IV Only     IV and Oral Abx     Total  
Number of Participants  
[units: participants]
  52     50     102  
Age  
[units: participants]
     
<=18 years     52     50     102  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  9.7  ± 4.2     10.1  ± 4.6     9.9  ± 4.4  
Gender  
[units: participants]
     
Female     20     23     43  
Male     32     27     59  
Region of Enrollment  
[units: participants]
     
United States     52     50     102  



  Outcome Measures

1.  Primary:   Abscess After Appendectomy   [ Time Frame: 1 month ]

2.  Secondary:   Length of Stay, Charges, Adverse Events   [ Time Frame: 1 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
none  


Results Point of Contact:  
Name/Title: Shawn D. St. Peter, MD
Organization: Children's Mercy Hospital
phone: 816-983-6479
e-mail: sspeter@cmh.edu


No publications provided


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
Study First Received: April 16, 2007
Results First Received: December 12, 2011
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board