patients between 18-65 years with lower respiratory tract infection and radiologically confirmed diagnosis of pneumonia
Conditions
Interventions
Trade Name: Penilevel
Pharmaceutical Form: Capsule
INN or Proposed INN: PHENOXYMETHYLPENICILLIN POTASSIUM
CAS Number: 132-98-9
Current Sponsor code: 660837
Concentration unit: IU international unit(s)
Sponsors
IDIAP Jordi Gol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 18 years to 65 years (inclusive). Signs and symptoms of lower respiratory tract infection. Radiological confirmation of the diagnosis of pneumonia or not radiological confirmation but the patient has the following symptoms: high fever (> 38.5 ° C), cough and purulent sputum and auscultation of crackles in a pulmonary focus, the researcher undertakes to confirm after inclusion pneumonia with mandatory radiological study. 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 168 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42
Exclusion criteria
Exclusion criteria: ? Impaired consciousness: confused state, delirium, drowsiness, stupor or coma, at medical discretion ? Respiratory rate> 30 breaths / minute ? Heart rate> 125 beats / minute ? Systolic blood pressure 40 ° C ? Bronchial Asthma ? Pregnancy or breastfeeding ? Comorbidity significant: renal failure, liver cirrhosis, heart failure, chronic obstructive pulmonary disease, ischemic heart disease, stroke and / or diabetes mellitus type 1 ? Important alteration in chest radiography: alveolar infiltrates in more than one lobe or bilateral pleural effusion or pulmonary cavitation ? Problems in order to meet the treatment at home: sociopathy or psychiatric problems, drug and alcohol addiction, or a family environment unsuitable ? Lack of tolerance to oral therapy: presence of nausea and vomiting, gastrectomy, post-surgery or frank diarrhea ? Immunosuppression: chronic HIV infection, transplant, neutropenic, or patients receiving immunosuppressive ? active Neoplasia ? Terminal illness ? Hospitalisation in the last month ? Taking antibiotics in the two weeks prior to the inclusion ? Difficulty to attend follow-up visits ? Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of phenoxymethylpenicillin (penicillin V) high-dose antibiotic treatment in non-severe pneumonia treated in the community versus high-dose amoxicillin considering clinical cure within two weeks;Secondary Objective: To evaluate the radiological healing and clinical cure in both treatment groups at four weeks of antibiotic treatment instituted. To evaluate the adverse effects on patients treated with both treatment groups;Primary end point(s): Clinical resolution at 14 days (visit 2 monitoring), defined as disappearance of fever, disappearance or improvement of cough, improvement of general condition and disappearance or reduction of auscultation of crackles, so no need to add any other treatment antimicrobial. Any other clinical outcome does not obey the above definition is considered treatment failure;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30 days;Secondary end point(s): Effectiveness month after initiation of antibiotic treatment (visit 3 tracking). It is considered the same definition as in the primary and will be defined by the researcher at visit 3 tracking based on medical history and physical examination. ? Resolution radiological month after initiation of antibiotic treatment (visit 3-up), defined by the investigator and / or radiologist as complete or partial resolution of pulmonary condensation image. ? total clinical resolution at 14 days (visit 2-up), defined as complete resolution of signs and symptoms related to acute infection so that it is not necessary to add any antimicrobial treatment. ? total clinical resolution a month after starting antibiotic treatment (visit 3 tracking). It will be defined by the researcher at visit 3 tracking based on medical history and physical examination. | — |
Countries
Spain
Contacts
Public ContactRosa Morros
IDIAP Jordi Gol
Outcome results
None listed