Genomics to combat resistance against antibiotics for community-acquired lower respiratory tract infection (LRTI) in Europe (GRACE) work package 10: Antibiotic Trial One
Phase 3
Completed
- Conditions
- ower respiratory tract infection (LRTI)RespiratoryUnspecified acute lower respiratory infection
- Registration Number
- ISRCTN52261229
- Lead Sponsor
- niversity of Southampton (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
1. Aged 18 and over, either sex
2. Acute or worsened cough is the main presentation suggesting LRTI, less than 28 days duration
3. Not been included earlier in the current GRACE trial
4. Able to fill out study materials
5. Immunocompetent
6. Not been on antibiotic treatment in previous month
7. First consultation for this illness episode
Exclusion Criteria
1. Allergic to penicillin
2. History/physical examination suggestive of community acquired pneumonia (CAP)
3. Pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Deterioration of illness: return to doctor with worsening signs, or admission to hospital within 4 weeks of first consultation, measured at one year<br>2. Symptom severity and duration, duration of symptoms rated moderately bad until symptoms clear, measured by symptom diary (with construct validity), measured at one year
- Secondary Outcome Measures
Name Time Method 1. Resource use data, assessed by a review of clinical notes measured at two years<br>2. Quality of life outcomes for use of economic evaluation (EQ5D), measured at two years<br><br>Added 25/11/2014:<br>3. Antibacterial resistance in oropharyngeal streptococci measured before, immediately after and four weeks after the interventions in five networks in the third inclusion period