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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
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

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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
e-mail: sspeter@cmh.edu



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