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

History of Changes

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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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 ]

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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

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

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

Other Adverse Events

	IV Only	IV and Oral Abx
Total, other (not including serious) adverse events
# participants affected / at risk	0/0	0/0

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

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