PER-009-22尚未招募3 期
A Phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of AB MOKS Forte coated tablet compared to amoxicillin 1g, 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):
- •B7 Dysnea. F0
- •B7 Tos new or increased. F0
- •B7 Production of purulent sputum. F0
- •Chest pain due to pneumonia. 4. Have at least 2 of the following
- •abnormalities in vital signs: F0
- •B7 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) . F0
- •B7 Hypotension (systolic arterial pressure < 90
- •B7 Tachycardia (heart rate > 100 beats/min.). F0
- •B7 Tachypnea
- •(respiratory rate > 20 breaths/min.). 5. Have at least another clinical sign or
- •bacterial pneumonia laboratory test: F0
- •B7 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). F0
- •B7 Halls of
- •auscultation and/or percussion compatible with pneumonia (for example,
- •crackles, egophonia, matidez). F0
- •B7 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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