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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN52261229 |
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Date of registration:
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16/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Genomics to combat resistance against antibiotics for community-acquired lower respiratory tract infection (LRTI) in Europe (GRACE) work package 10: Antibiotic Trial One
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Scientific title:
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Genomics to combat Resistance against Antibiotics for Community-acquired lower respiratory tract infection (LRTI) in Europe (GRACE) work package 10: Antibiotic Trial One - a randomised placebo-controlled double-blind trial |
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Date of first enrolment:
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15/11/2007 |
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Target sample size:
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3000 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN52261229 |
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Study type:
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Interventional |
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Study design:
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Randomised placebo-controlled double-blind trial (Treatment)
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Phase:
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Phase III
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Netherlands
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Poland
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Slovakia
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Slovenia
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Paul
Little |
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Address:
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Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
SO16 5ST
Southampton
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Name:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lower respiratory tract infection (LRTI)
Respiratory
Unspecified acute lower respiratory infection
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Intervention(s)
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1. Amoxicillin capsule, gastroenteral use, 3 g a day for 7 days
2. Placebo
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Primary Outcome(s)
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1. Deterioration of illness: return to doctor with worsening signs, or admission to hospital within 4 weeks of first consultation, measured at one year
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
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Secondary Outcome(s)
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1. Resource use data, assessed by a review of clinical notes measured at two years
2. Quality of life outcomes for use of economic evaluation (EQ5D), measured at two years
Added 25/11/2014:
3. Antibacterial resistance in oropharyngeal streptococci measured before, immediately after and four weeks after the interventions in five networks in the third inclusion period
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Secondary ID(s)
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GRACE WP10 Protocol v4.1 18/09/2007; GRACE WP10 Protocol v4.2 21/4/2009 (to extend the study with additional networks and a third inclusion period and, only in five networks in the third inclusion period, with an additional objective with associated samples)
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2007-001586-15
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Source(s) of Monetary Support
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Sixth Framework Programme
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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