EUCTR2017-001406-15-ES
Active, not recruiting
Phase 1
Adequate duration of antibiotic treatment in community acquired pneumonia categorized by pneumonia severity index (PSI)
Fundació Clínic per la Recerca Biomèdica0 sites424 target enrollmentApril 9, 2018
ConditionsCommunity Acquired PneumoniaMedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsActira
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Community Acquired Pneumonia
- Sponsor
- Fundació Clínic per la Recerca Biomèdica
- Enrollment
- 424
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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