Trial Outcomes & Findings for Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis (NCT NCT00462020)

NCT ID: NCT00462020

Last Updated: 2021-02-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2021-02-21

Participant Flow

All patients with perforated appendicitis were recruited for this study.

Participant milestones

Measure	IV Only 5 days of IV antibiotics after appendectomy	IV and Oral Abx home on oral antibiotics to complete 7 days of treatment
Overall Study STARTED	52	50
Overall Study COMPLETED	52	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis

Baseline characteristics by cohort

Measure	IV Only n=52 Participants 5 days of IV antibiotics after appendectomy	IV and Oral Abx n=50 Participants home on oral antibiotics to complete 7 days of treatment when tolerating PO's	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	52 Participants n=5 Participants	50 Participants n=7 Participants	102 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9.7 years STANDARD_DEVIATION 4.2 • n=5 Participants	10.1 years STANDARD_DEVIATION 4.6 • n=7 Participants	9.9 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	27 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	50 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Measure	IV Only n=52 Participants 5 days of IV antibiotics after appendectomy	IV and Oral Abx n=50 Participants home on oral antibiotics to complete 7 days of treatment when tolerating PO's
Abscess After Appendectomy	10 number of patients	10 number of patients

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Measure	IV Only n=52 Participants 5 days of IV antibiotics after appendectomy	IV and Oral Abx n=50 Participants home on oral antibiotics to complete 7 days of treatment when tolerating PO's
Operative Time	41.06 Minutes Standard Deviation 15.36	46.30 Minutes Standard Deviation 19.42

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Measure	IV Only n=52 Participants 5 days of IV antibiotics after appendectomy	IV and Oral Abx n=50 Participants home on oral antibiotics to complete 7 days of treatment when tolerating PO's
Time to Regular Diet	68.00 Hours Standard Deviation 35.06	61.42 Hours Standard Deviation 32.12

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Measure	IV Only n=52 Participants 5 days of IV antibiotics after appendectomy	IV and Oral Abx n=50 Participants home on oral antibiotics to complete 7 days of treatment when tolerating PO's
Length of Stay After Operation	6.06 Days Standard Deviation 2.00	4.48 Days Standard Deviation 2.36

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Measure	IV Only n=52 Participants 5 days of IV antibiotics after appendectomy	IV and Oral Abx n=50 Participants home on oral antibiotics to complete 7 days of treatment when tolerating PO's
Total Healthcare Visits	3.1 Visits Standard Deviation 1.4	3.1 Visits Standard Deviation 1.2

Adverse Events

IV Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IV and Oral Abx

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shawn D. St. Peter, MD

Children's Mercy Hospital

Phone: 816-983-6479

Email: sspeter@cmh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place