PER-010-22尚未招募3 期
A Phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of AB MOKS coated tablet compared to amoxicillin tablets 500 mg, two tablets administered every 8 hours orally for 10 days, in the treatment of outpatient community-acquired pneumonia.
MEDIFARMA S A0 个研究点目标入组 0 人开始时间: 2023年12月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Being a man or woman mayor aged =18 years.
- •2. Informed consent signed and closed in accordance with GCP guidelines and local legislation.
- •3. Have an acute illness (duration =7 days) with at least 3 of the following symptoms compatible with an infection of the lower respiratory tract (new):
- •? Tos new or increased.
- •? Production of purulent sputum.
- •? Chest pain due to pneumonia.
- •4. Have at least 2 of the following abnormalities in vital signs:
- •? Fever (body temperature > 38.0 °C measured orally or equivalent temperature of an alternative body spot) or hypothermia (body temperature < 35.0 °C measured orally or equivalent temperature of an alternative body spot) .
- •? Hypotension (systolic arterial pressure < 90 mmHg).
- •? Tachycardia (heart rate > 100 beats/min.).
- •? Tachypnea (respiratory rate > 20 breaths/min.).
- •5. Have at least another clinical sign or bacterial pneumonia laboratory test:
- •? Hypoxemia (decir, O2 saturation < 90% with ambient air or when supplemental oxygen is received according to the subject's initial requirements or PaO2 < 60 mmHg).
- •? Halls of auscultation and/or percussion compatible with pneumonia (for example, crackles, egophonia, matidez).
- •? Leukocyte count (RL) > 10,000 cells/mm3 or < 4,500 cells/mm3 or > 15% of inmature neutrophils (band forms), regardless of the total RL.
- •6. Have pneumonia documented by radiography within 48 hours prior to enrollment (decir, infiltrates in a lobular or multilobular distribution) or diffuse opacities on a chest X-ray or CT scan compatible with acute bacterial pneumonia).
- •7. Have a risk class of I or II, according to the Equipo de Investigacion de Results de la pneumonia (PORT, Pneumonia Patient Outcomes Research Team, see Annex 1) and/or be a suitable candidate for treatment with oral antibiotics of outpatient management as a treatment for the current episode of NAC.
- •8. Women in fertile age must comply with using an effective MAC.
排除标准
- •1. Having received more than a single dose of a fast-acting antibacterial treatment by mouth or i.v. for the NAC in the 72 hours before the randomization.
- •2. Require concomitant systemic antibacterial treatment, possibly effective against NAC pathogens.
- •3. Having been hospitalized for 2 or more days within the 90 days prior to the onset of symptoms, or having lived in an asylum or in a long-term health center within the 30 days prior to the onset of symptoms.
- •4. Have to suspect or confirm CANC caused by a pathogen known to be resistant to amoxicillin (for example, MRSA, Pseudomonas aeruginosa, any pathogen of the enterobacteriaceae family) or attributable to different etiologies (such as those caused by fungi or viruses or mycobacteria).
- •5. Check for confirmation of pleural empyema (does not include sterile paraneumonic effusions).
- •6. Have a history of liver, hematologic or immune disease.
- •7. Clinically unstable heart disease, which includes: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia or permanent pacemaker.
- •8. Known to have severe immunosuppression, which includes but is not limited to the administration of corticosteroid treatment (=20 mg of prednisone/day or the equivalent of >4 weeks) in the previous 8 weeks; bone marrow or solid organ transplantation within the previous 12 months; or receiving cytotoxic chemotherapy.
- •9. Have participated in a study with the administration of an agent or device in the investigation phase within 30 days or = 5 half-lives of terminal elimination of the drug in the previous investigation phase.
- •10. Hypersensitivity to penicillins and other structurally related antibiotics.
- •11. AB-MOKSH hypersensitivity to ambroxol
- •12. Gastrointestinal disorders or history of antibiotic-associated colitis: Penicillins can cause pseudomembranous colitis.
- •13. Infectious mononucleosis.
- •14. History of peptic ulcer, since mucolytic agents can alter the gastric mucosal barrier.
- •15. Signs of liver disease, defined by serum levels of ALT (SGPT), AST (SGOT), or alkaline phosphatase greater than 3 x the upper limit of normal value (ULN) as determined during the selection and/or preparatory period .
- •16. Renal failure, with creatinine clearance less than 30ml/min.
- •17. Gastrointestinal surgery that can induce chronic malabsorption.
- •18. Medical history of cancer (except basal cell carcinoma) and/or treatment for cancer within the previous 5 years.
- •19. Blood disorders or any other disorder causing hemolysis or unstable red blood cells (half-life shortening) (for example, malaria, babesiasis, hemolytic anemia).
- •20. Medication treatment to treat obesity within the 3 months prior to informed consent or any other treatment at the time of selection (for example, surgery, aggressive diet regimen, etc.) that produce an unstable body weight.
- •21. Current treatment with aminoglycosides and penicillins.
- •22. Current treatment chloramphenicol, erythromycins, sulfonamides or tetracyclines
- •23. Current treatment with Allopurinol
- •24. Current treatment with antitussives
- •25. Current treatment with methotrexate
- •26. Current treatment with probenecid
- •27. Embarrassment and lactation
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