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Clinical Trials/EUCTR2011-004495-12-NL
EUCTR2011-004495-12-NL
Active, not recruiting
Phase 1

Antibiotic treatment alone for children with acute appendicitis; a prospective cohort study part of the Antibiotic versus Primary Appendectomy for Children with acute appendicitis; the APAC trial.

VU University Medical center0 sites50 target enrollmentApril 11, 2013
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DrugsAugmentinAmoxicillin / clavulanic acid

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
VU University Medical center
Enrollment
50
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 11, 2013
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
VU University Medical center

Eligibility Criteria

Inclusion Criteria

  • •Written Informed consent obtained
  • •Age 7\-17 years
  • •Radiologically confirmed simple appendicitis, defined as:
  • •a.Clinical findings:
  • •i.Unwell, but not generally ill
  • •ii.Localized tenderness in the right iliac fossa region
  • •iii.Normal/hyperactive bowel sounds
  • •iv.No guarding
  • •v.No mass palpable
  • •b.Ultrasonography:

Exclusion Criteria

  • •The following patients will be excluded from participating in this study:
  • •1\.Patients with severe general illness at time of presentation:
  • •a.Generalized peritonitis defined as:
  • •Diffuse inflammation of the peritoneum with clinical signs consisting of increasing abdominal pain, generalized tenderness, diffuse abdominal rigidity, sinus tachycardia, signs of paralytic ileus
  • •b.Severe sepsis or septic shock, as defined by the international paediatric sepsis consensus conference \[36]. See attachment 1\.
  • •2\.Patients with serious associated conditions or malformations such as:
  • •a.Congenital or acquired cardiac or pulmonary disease with significant hemodynamic consequences
  • •b.Immunodeficiency
  • •c.Malignancy
  • •d.Homozygous sickle cell disease

Outcomes

Primary Outcomes

Not specified

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