Active Ingredients: Amoxicillin
Subject numbers will be assigned sequentially as each subject enters the study. The subjects will be assigned a study drug through a randomisation schedule based on the randomisation plan. Since this is a multicentre study a block procedure will be undertaken for the assignment of each primary care centre participating in the study.
Each container will include 66 pills 60 pills for the treatment plus 6 extra pills.
The study drug, which will be prepared by the Pharmacy Unit of Hospital Universitari Son Espases Palma de Mallorca, Spain and will be labelled with the study number and a unique identification number.
Use of antithermic drugs or analgesics acetaminophen, acetylsalicylic acid or ibuprofen, bronchodilators as well as any medication, except oral systemic antibiotics, that the patient is taking and which have been initiated prior to inclusion in the study will be allowed.
The two medications will be presented as the same type of capsule.
This will ensure that even on opening the container no one will know which medication has been given. Withdrawal Each participant will have the right to withdraw from the study at any time.
In cases of clinical deterioration the medical investigator will implement another antibiotic treatment considering the clinical criteria, withdrawal of consent or loss to follow up.
Ascertainment of visits On fulfilling the inclusion criteria the nature of the study will be explained to the patient and informed consent will be requested. All the eligible patients should have a chest X-ray posteroanterior and lateral projection demonstrating pneumonic infection.
The patients will be randomised to one of the 2 treatment groups and the medication given. They will be dispensed the drugs for ten days.
Table 1 Variables to be collected during the clinical trial Full size table At the first follow-up visit, scheduled at day 3, a worsening of the clinical situation of the patient will be evaluated to determine whether a change in the antibiotic treatment is necessary.
Likewise, compliance and possible secondary effects of the treatment will be evaluated.
At the second follow-up visit, at day 14, the clinical evolution of the signs and symptoms will be evaluated and the need to change the antibiotic treatment in the case of worsening in the clinical manifestations will be determined.
The last follow-up visit, scheduled at day 30, the clinical outcome of the signs and symptoms of the pneumonia will be evaluated and a new chest X-ray will be performed posteroanterior and lateral projection to confirm radiological resolution of the pneumonia.
The medication will be discontinued in the case of clinical failure in follow-up visits 2 and 3 or in the case of significant adverse events.
The variables considered in this trial will be sociodemographic birth date, gender, race and toxic habits smoking and drinking behaviours, present medical history presence and duration of signs and symptoms: fever, cough, expectoration, sputum purulence, diarrhoea, malaise, muscular aches, joint aches, thoracic pain, dyspnoea, respiratory auscultation; and details of any history of high blood pressure, type 2 diabetes mellitus or hypercholesterolemia, physical examination axillary temperature, resting pulse, respiratory rate, blood pressure measurements, oxygen saturation, and auscultation abnormalities and X-ray findings.
Sample size The objective of the study is to demonstrate that penicillin V is not inferior to amoxicillin. To evaluate the comparability of the groups the two groups will be analysed with variables expressed as means and standard deviations for the case of quantitative variables and with proportions in the case of qualitative variables.
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