Optimized treatment for uncomplicated acute appendicitis - active observation with or without antibiotic treatment. A phase IV consecutive clinical treatment trial.
Phase 1
- Conditions
- Acute appendicitisTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2018-001578-71-SE
- Lead Sponsor
- Göteborgs Universitet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Patients presenting with symptoms of clinical acute appendicitis
Age >18 <60 years
CRP <60mg/L
White blood cell count <13x10e9 /ml
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Evident or suspected pregnancy
Known allergic reaction towards penicillin or similar antibiotics
Precence of intercurrent disease that are judged relevant for the patient
Contraindications of antibiotic treatment (disease, medication or organ dysfunction)
Dyscompliance (lack of id, language understnding etc.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method