Study design
Multicentre cohort study, carried out in 4 hospitals in the Basque
public network, which evaluated complications after one year in patients
who had previously been included in a randomized clinical trial on the
duration of antibiotic treatment in patients admitted for CAP. In the
clinical trial intervention group, antibiotic treatment was prescribed
for a minimum of 5 days and was suspended if for 48 hours the
temperature was ≤ 37.8ºC and there was no more than 1 sign of clinical
instability as defined by Halm’s clinical stability criteria (heart rate
<100, respiratory rate <24, axillary temperature
<37.2C, systolic blood pressure> 90, saturation
and O2> 90%, good level of consciousness and tolerance of
the oral route) 5. In the control group, the doctor
decided on the duration of the antibiotic treatment. In a slight
variance from established norms, the doctor him/herself chose the type
of antibiotic. The follow-up period of the original clinical trial
patients was 30 days, while the present study extended the follow-up
period from 30 days to one year.
All patients were informed about the study and asked to give their
informed consent. The project was approved by the Basque Country Ethics
Committee (2011-001067-51).