None listed
Conditions
Interventions
Group 1 Type of group
NXL103, 500 mg twice a day for 7 days.
Group name:Group 3 Type of group
Amoxicillin, 1000 mg three times a day for 7 days.
Sponsors
NOVEXEL S.A.,
Eligibility
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cure: All signs and symptoms related to infection disappeared or improved or returned to the state prior to infection and the results of chest radiography showed improvement or lack of progression of all abnormalities present in the baseline assessment Measure:Clinical result in the Cure Test Visit (TDC) held on Days 14-21 Timepoints:Days 14-21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The bacteriological result per subject is evaluated blindly. It is based on the result of asylated pathogen in the initial visit (considered causative) and in the isolation of any new pathogen during the course of treatment or the post-treatment period. Measure:Bacteriological result in the TDC and remote post-treatment. Timepoints:Days 14-21 ; Outcome name:Cure: All signs and symptoms related to infection disappeared or improved or returned to the state prior to infection and the results of chest radiography showed improvement or lack of progression of all abnormalities present in the baseline assessment Measure:Clinical result in the remote post-treatment Timepoints:Days 28 and 35 | — |
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed