A Phase III randomized, double-blind, parallel-group study to evaluate the efficacy and safety of AB MOKS Powder Suspension administered every 8 hours compared to amoxicillin (Amoxil® 250 mg/5ml Powder for Oral Suspension) for 7 days in the treatment of outpatient community-acquired pneumonia in children.

Phase 3

• Conditions: J998 Respiratory disorders in other diseases classified elsewhere; Respiratory disorders in other diseases classified elsewhere; J998

• Registration Number: PER-011-22
• Lead Sponsor: MEDIFARMA S A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-29
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Without startig enrollment
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Confirmed diagnosis of non-serious community-acquired pneumonia (subject with fever, cough, and tachypnea).
2. Age = 2 years =7 years
3. Signed and dated written informed consent in accordance with GCP guidelines and local law.

Exclusion Criteria

1. Subject diagnosed with pneumonia who presents any of the following severity criteria:
-Moderate to severe respiratory distress
• RR>50 breaths/minute for children.
• Suprasternal, intercostal retractions
• Rales or crackles
• Nasal flaring
• Freediving
-Cyanosis
-Tachycardia (=140 bpm from 3 to 5 years, >120 bpm from 5 years and older)
-Hypoxemia (sustained oxygen saturation <92 percent in room air at sea level)
-Signs of dehydration
-Capillary refill = 2 seconds
2. Research subject who is allergic to one of the components of AB-MOKS powder for suspension (amoxicillin or ambroxol).
3. History of sensitivity to multiple allergens.
4. Gastrointestinal conditions or a history of antibiotic-associated colitis: Penicillins can cause pseudomembranous colitis.
5. Infectious mononucleosis.
6. History of peptic ulcer, since mucolytic agents can disrupt the gastric mucosal barrier.
7. Signs of liver disease, defined by serum ALT (SGPT), AST (SGOT), or alkaline phosphatase levels greater than 3 x the upper limit of normal (ULN) as determined during the screening and/or preparatory period.
8. Renal failure, with creatinine clearance less than 30ml/min.
9. Gastrointestinal surgery that can induce chronic malabsorption.
10. Medical history of cancer.
11. Blood dyscrasias or any other disorder causing hemolysis or unstable red blood cells (shortened half-life) (eg malaria, babesiosis, hemolytic anemia).
12. Current treatment with aminoglycosides and penicillins.
13. Current treatment chloramphenicol, erythromycins, sulfonamides or tetracyclines
14. Current treatment with Allopurinol
15. Current treatment with antitussives
16. Current treatment with methotrexate
17. Current treatment with probenecid
18. Any ongoing condition or condition that may result in decreased compliance with study procedures or study drug administration, at the discretion of the Investigator.
19. Administration of an investigational drug from another clinical study within 30 days prior to administration of the study drug in this study, or participation in the follow-up period of another study (participation in observational studies is allowed).
20. Any other clinical condition that, in the investigator's opinion, would jeopardize the safety of the research subject while participating in this clinical study.

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: Day 5 to 10 of the end of treatment