Clinical trial NCT03609099: Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response
Official title: Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Community-acquired Pneumonia
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
name: Miquel Ferrer - Investigator Coordinator
First posted: 2018-08-01
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes older than 18 years
* Hospitalized patients diagnosed with CAP: appearance of a new radiological infiltrate plus the presence of at least two of the following signs or symptoms: fever (\> 38 ° C), cough, expectoration, chest pain, dyspnea or tachypnea, and signs of occupation of the alveolar space.
* That they present a PSI score class IV or V.
* Patients who have received adequate antibiotic treatment according to clinical guidelines (SEPAR, ATS) ((1,8,19)) from the first hour of admission to the emergency room.
* Patients who reach clinical stability: temperature ≤37.2 ºC, heart rate ≤100 beats / min, respiratory rate ≤24 breaths / min, systolic blood pressure\> 90 mmHg; oxygen saturation\> 90%; or oxygen blood pressure\> 60 mmHg (15) before the fourth day.
* Signature of informed consent.

Exclusion Criteria:

* Immunosuppression: Co infection with HIV and presence of AIDS, treatment with neutropenic effect or have received immunosuppressive treatment for any reason. Patients that are in chronic use of corticosteroids as prednisone or its equivalent with \> 10 mg / day for 14 days.
* Patients hospitalized in the previous 14 days.
* Patients with pleural effusion
* Suspected multiresistant germs of any cause.
* Hypersensitivity or alterations in the tendons associated with the fuoroquinolones.
* Pregnancy or lactation.

Primary outcomes:
measure: Rate of treatment failure
timeFrame: during the 30 days after the day of hospital admission
Secondary outcomes:
measure: Length of hospital stay
timeFrame: up to 2 years
measure: Antibiotic-free days
timeFrame: Up to 28 days
measure: Proportion of adverse events
timeFrame: Up to 28 days
measure: Proportion of serious adverse events
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
state: Bizkaia
city: València
country: Spain
facility: Hospital Universitario La Fe
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
Study officials:
References: