Pacientes de 18 a 65 años que presentan bronquitis aguda con esputo purulento MedDRA version: 9.1 Level: LLT Classification code 10000687 Term: Acute bronchitis
Conditions
Interventions
Product Name: Amoxicillin and clavulanic acid
Pharmaceutical Form: Tablet
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787780
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Institut Català de la Salut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 15 to 65, without significant comorbidities, who present a respiratory tract infection of less than one week, with cough as the fundamental symptom and presence of purulent sputum and at least another symptom of respiratory tract, such as dyspnea, wheezing, thoracic disconfort, and/or pain, that cannot be explained by another disease such as pneumonia. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Radiological sign of pneumonia 2. Signs of severe infection: confusion, respiratory rate over 25 bretahs/minute, heart rate over 120 beats/minute 3. History of digestive bleeding or intolerance to anti-inflammatory treatment 4. Hypersensitivity to betalactams or intolenace to amoxicillin and clavulanic acid 5. Pregnancy 6. Antibiotic or anti-inflammatory drugs taken over the last two weeks 7. Significant comorbidities associated, such as asthma, chronic obstructive pulmonary disease, immunodepression and immunosupressive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical effectiveness of an non-steroidal anti-inflammatory treatment for 10 days compared with an antibiotic regimen (amoxicillin and clavulanic acid) and placebo;Secondary Objective: 1. To assess the speed of resolution of symptoms among patients with acute bronchitis allocated to the three regimens 2. Assess the resolution of peak-flow measurement among patients with acute bronchitis allocated to the three regimens 3. To determine the role of C-reactive protein level on the resoluction of symptoms and signas and comprove if differences among the three regimens are observed depending on the CRP level 4. To assess the side effects of the three regimens;Primary end point(s): Clinical outcome: - success: complete resolution of symptoms and signs associated with acute bronchitis - improvement: incomplete resolution of symptoms and signs associated with acute bronchitis - failure: worsening of symptoms that make necessary the administration of an appropriate treatment | — |
Countries
Spain
Outcome results
None listed