Community Acquired Pneumonia MedDRA version: 20.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Actira
Product Name: Moxifloxacin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Moxifloxacin
CAS Number: 151096-09-2
Current Sponsor code: Moxifloxacin
Other descriptive nam
Sponsors
Fundació Clínic per la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 212
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 5-day antibiotic treatment compared to the usual treatment for more than 7 days in terms of treatment failure, during the 30 days after the day of hospital admission, in patients with Community Acquired Pneumonia with a PSI IV-V severity score that present an adequate initial response according to the criteria of Halm et al (clinical stability before the 4th day after admission).;Secondary Objective: 1. To evaluate the efficacy of 5-day antibiotic treatment compared to the usual treatment for more than 7 days in terms of time of hospital stay and antibiotic-free days during the first 30 days after hospital admission in the same selected population 2. To evaluate the safety of antibiotic treatment for 5 days compared to the usual treatment for more than 7 days in the same selected population;Primary end point(s): Rate of treatment failure during the first 30 days after hospital admission: - Death for any reason during the first 30 days after hospital admission. - Hospital re-admission for any reason during the first 30 days after the day of hospital admission. - Restart antibiotic treatment for any reason during the first 30 days after hospital admission.;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Length of hospital stay Antibiotic-free days Adverse events (AE) Serious adverse events (SAE);Timepoint(s) of evaluation of this end point: 60 days | — |
Countries
Spain
Contacts
Public ContactAdrian Ceccato
Fundació Clínic per la Recerca Biomèdica
Outcome results
None listed