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.
- Conditions
- J988 Other specified respiratory disordersOther specified respiratory disordersJ988
- Registration Number
- PER-009-22
- Lead Sponsor
- MEDIFARMA S A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without startig enrollment
- Sex
- All
- Target Recruitment
- 0
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):
F0
B7 Dysnea. F0
B7 Tos new or increased. F0
B7 Production of purulent sputum. F0
B7
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
mmHg). F0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of clinical<br>response with clinical<br>parameters of<br>symptom intensity<br> NAME OF THE RESULT: Clinical Cure Testing<br>(TOC)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: 10 days of treatment
- Secondary Outcome Measures
Name Time Method