Lower Respiratory Tract Infection MedDRA version: 9.1 Level: LLT Classification code 10008477 Term: Chest infection MedDRA version: 9.1 Level: LLT Classification code 10024968 Term: Lower respiratory tract infection
Conditions
Interventions
Trade Name: Galenamox caps
Pharmaceutical Form: Capsule*
INN or Proposed INN: amoxycillin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form o
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients will be those who are: • Aged 18 years to 59 years and 60 years and over (enrolment will be done in such a way that 1500 patients under 60 and 1500 patients of 60 years and older) • Consulting with acute cough as the main symptom (up to and including 28 days duration) or those in whom the general practitioner suspects the presence of acute lower respiratory tract infection • Immuno-competent (no serious immunological deficiencies) • Consulting for the first time within this illness episode • Able to fill out study materials • Who have provided written, informed consent to participate • Who have not been included earlier in the current GRACE trial, either as a case or a control patient 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have had antibiotics in the previous month (altered flora): patients who are unable to properly consent or fill out the diary (dementia, psychosis, severe depression): and patients who are pregnant; patients who are allergic to penicillin, and those with history/physical examination suggestive of community acquired pneumonia - on ethical grounds; practitioners would be very unlikely to be willing to randomise patients with CAP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: General objective 1. To understand which individuals benefit from antibiotics. To study the clinical effectiveness of antibiotics in community-acquired LRTI by means of a randomised placebo-controlled double-blind trial with patients as unit of randomisation. ;Secondary Objective: Specific objectives 1. To generate the evidence required to contain antibiotic resistance by showing which subgroups of patients benefit and which do not benefit from antibiotics, identified from the observational studies. 2. To assess the role of host and microbial genomics and antibiotic resistance in determining benefit from antibiotics. 3. To estimate the overall benefit from antibiotics and in different age groups (adults and the elderly) and different clinical subgroups (e.g. systemic symptoms, clinical signs). ;Primary end point(s): 1) Deterioration of illness. We will document significant deterioration of illness - which is defined as a return to the doctor with a worsening symptoms, new symptoms, new signs, or requiring admission to hospital within four weeks after the first consultation which has been used as a workable definition in previous studies of respiratory tract infection in the community; this includes pneumonia following uncomplicated community-acquired LRTI, sepsis, acute cerebrovascular and cardiovascular disease, exacerbations of concomitant high-risk disease, or death. 2) Symptom severity and duration. Our other main outcome is based on a symptom diary, which uses a format similar to previous diaries, and is based on the premise that the main outcome should reflect when patients report symptoms are a problem. The diary has construct validity - good correlation with the validated Measure Yourself Medical Outcome Profile - is sensitive to change, and internally reliable (Cronbach’s alpha 0.75 i.e. in optimal range). Our main symptomatic outcomes will be the duration of symptoms rated moderately bad by patients, and the mean diary score for days 2 t | — |
Countries
Slovenia
Outcome results
None listed