GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe).Workpackage 10: Antibiotic Trial One

Primary outcome parameters.

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 to 4 when symptoms are rated as

the worst problem by patients. Before day 2 antibiotics will have little chance

to provide benefit, and after day 4 on average symptoms are less than a

moderate problem.

Other outcome parameters:

Resource use data from the societal perspective will be documented - based on

review of the clinical notes. We will also collect quality of life outcomes for

use of economic evaluation (the EQ5D will be filled in at the end of each week

of the symptom diary)