drugset / Trial / NCT01356641

Antibiotic Treatment Alone for Acute Simple Appendicitis in Children

NCT01356641

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of life and lower costs have been associated with antibiotic treatment alone. Five clinical trials in selected patients (males, older than 18 years) comparing appendectomy and antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the efficacy of antibiotic treatment alone in children with proven acute appendicitis however is lacking. We propose a prospective cohort study to answer the following questions:

Timeline

Start
2012-09
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 50 mg/kg Intravenous
Subject Amoxicillin Other / unclassified 100 mg/kg Intravenous
Subject Gentamicin Small molecule 7 mg/kg Intravenous
Subject clavulanic acid Small molecule 10 mg/kg Intravenous
Subject clavulanic acid Small molecule 12.5 mg/kg Intravenous

Indications