DOUBLE-BLIND, MULTICENTER, MULTINATIONAL, RANDOMIZED, DOUBLE-SIMULATED, THREE-PARALLEL GROUP, STUDY INTENDED TO COMPARE THE EFFICACY, SAFETY AND TOLERANCE OF NXL103 ADMINISTERED BY ORAL ROUTE (500 MG TWICE A DAY) IN FRONT OF NXL103 ADMINISTERED BY ROAD ORAL (600 MG TWICE A DAY) AGAINST ORAL AMOXICILLIN (1000 MG THREE TIMES A DAY) IN THE TREATMENT OF PNEUMONIA ACQUIRED IN THE COMMUNITY IN ADULTS

Not Applicable

• Conditions: -J129 Viral pneumonia, unspecified; Viral pneumonia, unspecified; J129

• Registration Number: PER-066-07
• Lead Sponsor: OVEXEL S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Only patients with mild to moderately severe pneumonia will be included in this study (the inclusion and exclusion criteria are designed to include only subjects with pneumonia with a CURB-65 score of 0 or 1).
• Informed consent of all subjects must be obtained prior to enrolling in the study.
• Adult male subjects between 18 and 70 years of age, female subjects have been postmenopausal for at least 1 year or are surgically unable to procreate.
• Subjects with acute NAC diagnosis
• Hospitalized (for study purposes or as local practice) or outpatients
• Subjects to whom samples must be taken for bacteriological documentation within 24 hours prior to enrollment.

Exclusion Criteria

• Subjects with severe NAC, defined as those requiring either hospitalization in an intensive care unit (ICU), parenteral antibiotic treatment
• Subjects with respiratory tract infections attributable to a source other than bacterial infections acquired in the community
• Subjects with any pulmonary disease, condition or concomitant complications that may confuse the interpretation or evaluation of the efficacy or safety of the drug
• Subjects with neoplastic lung disease (lung cancer) or other malignancy with pulmonary metastases, and / or requirement for chemotherapeutic intervention for these or other neoplasms.
• Subjects who are receiving other medications, including other systemic antimicrobial agents, or who have other disease conditions or infections that may interfere with the evaluation of the efficacy or safety of the drug.
• Subjects who have received treatment with other antibiotics for more than 24 hours in the 7 days prior to enrollment in the study.
• Subjects treated with azithromycin or dirithromycin, ceftriaxone, quinolones, amoxicillin and amoxicillin / clavulanic acid in the 7 days prior to enrollment.
• Subjects with a microbiologically documented infection with a pathogen known to be resistant to study medication before inclusion in it.
• Subjects with known or suspected hypersensitivity, or a serious adverse reaction known or suspected to the study medication, to macrolide antibiotics or to b-lactam antibiotics.
• Subjects receiving treatment with probenecid.
• Subjects who are going to need during the treatment of the study drugs that are known to have interactions with drugs contraindicated with the study medication and / or the macrolides in general
• Subjects with prolonged QTc syndrome, confirmed, sick sinus syndrome, bradycardia (heart rate <50 beats / minute), or severe hypokalemia.
• Subjects who have received any investigational drug in the month prior to entering the study or who have scheduled that type of treatment during the study period.
• Subjects with a fatal progressive disease; Life expectancy <3 months.
• Subjects with any concomitant condition, including cardiovascular, neurological, clinically relevant endocrine, or other important systemic disease that may hinder the implementation of the protocol or the interpretation of the study results.
• Subjects with a recent history (within the previous 3 months) of drug or alcohol abuse.
• Subjects with impaired hepatic function
• Subjects with altered renal function, observed by a creatinine clearance <50 mL / min (creatinine clearance can be estimated with the formula).
• Pregnant or lactating woman.
• Immunocompromised subjects
• Subjects with a mental condition that makes the subject unable to understand the nature, scope and possible consequences of the study.
• Subject who can not comply with the protocol (eg, non-cooperative attitude, inability to return to follow-up visits, and improbability of completing the study).

Study & Design

• Study Type: Interventional
• Study Design: Not specified