Assess the optimal duration of pneumonia antibiotic treatment

Phase 1

Conditions: Community Acquired Pneumonia
MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2017-001406-15-ES

Lead Sponsor: Fundació Clínic per la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 424

Inclusion Criteria

1) Hospitalized patients diagnosed with Community Acquired Pneumonia: appearance of a new radiological infiltrate plus the presence of at least two of the following signs or symptoms: fever (> 38 ºC), cough, expectoration, chest pain, dyspnea or tachypnea, and signs of occupation of the alveolar space.
2) A PSI score class IV or V.
3) Patients who have received adequate antibiotic treatment according to clinical guidelines from the first hour of emergency room admission.
4) Patients who achieve 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.
5) Signature of informed consent.
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 212
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 212

Exclusion Criteria

1) Immunosuppression: Coinfection with HIV and presence of AIDS, neutropenic or have received immunosuppressive treatment for any cause. Patients with chronic use of corticosteroids (prednisone or its equivalent)> 10 mg / day for 14 days.
2) Patients hospitalized in the previous 14 days.
3) Suspected multi-resistant germs of any cause.
4) Hypersensitivity or alterations in the tendons associated with the fuoroquinolones.
5) Pregnancy or lactation