Non-inferiority, multicenter, prospective double-blind, randomized clinical trial of two parallel groups. The randomization between the 2 study groups will be carried out according to a scheme generated by a computer program, in blocks of 6 and stratified by centers. The antibiotic treatment will be evaluated during 5 days compared to the usual antibiotic treatment for more than 7 days in patients with community-acquired pneumonia with a Pneumonia Severity Index IV-V severity score who present an adequate response in the first 4 days of hospital antibiotic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
424
400 mg / day once a day oral treatment during 3 days.
once a day oral treatment during 3 days.
Hospital de Mataró
Mataró, Barcelona, Spain
RECRUITINGHospital Galdakao-Usansolo
Galdakao, Bizkaia, Spain
RECRUITINGHospital Universitario La Fe
Valencia, Valencia, Spain
RECRUITINGHospital Clínic i Provincial de Barcelona
Barcelona, Spain
RECRUITINGHospital Universitario Virgen de Valme
Seville, Spain
RECRUITINGRate of treatment failure
Treatment failure is defined as the appearance of any of the following manifestations: death from any cause, hospital readmission for any cause or restart of antibiotic treatment for any reason.
Time frame: during the 30 days after the day of hospital admission
Length of hospital stay
Time frame: up to 2 years
Antibiotic-free days
Antibiotic-free days are defined as the number of days alive and free of antibiotics
Time frame: Up to 28 days
Proportion of adverse events
Time frame: Up to 28 days
Proportion of serious adverse events
Time frame: Up to 28 days
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