Community-acquired pneumonia. This disease can be defined as an acute lower respiratory tract infection not acquired in a hospital or a long-term care facility. MedDRA version: 9.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia
Conditions
Interventions
Product Name: Faropenem medoxomil
Product Code: REP319740
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Faropenem medoxomil
CAS Number: 141702-36-5
Current Sponsor code: REP319740
Conce
Sponsors
Replidyne, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female 18 years of age or older 2. Subjects with fever documented within the past 24 hours (PO >38oC/100.4oF; Axillary >37.5oC/99.5oF; TM or Rectal >38.5oC/101.2oF) 3. Subjects who can produce an adequate (i.e., sputum Gram stain with >25 PMNs/LPF and 20 breaths per minute [bpm] but = 30), particularly if progressive in nature • Pleuritic chest pain • Auscultatory findings on pulmonary examination of rales/rhonchi and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony) 6. Subjects who are able to take oral medication 7. If female of childbearing potential, the subject must: • have maintained her normal menstrual pattern during the 3 months prior to trial entry, AND • have taken hormonal contraceptives for at least 1 month prior to trial entry, or agree to use spermicide and barrier methods or have been using another acceptable method of contraception and agree to continue with the same method during the trial, AND • have had a negative urine ß- subunit hCG pregnancy test sensitive to at least 50 µU/mL of ß- hCG immediately prior to trial entry NOTE: Female subjects who have a positive pregnancy test and become pregnant during the trial must be promptly withdrawn from the trial 8. Read and sign ICF and, if applicable, any local data privacy requirements. By signing the ICF, the subject agrees to release any medical records pursuant to all current local data privacy requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of hypersensitivity to faropenem medoxomil or clarithromycin or a history of an anaphylactic reaction to ß-lactams (e.g., penicillins, cephalosporins or carbapenems) or allergy to the macrolide family of antimicrobials 2. Subjects with a positive urinary antigen test for L. pneumophila at the Pre Therapy visit (Visit 1) 3. Subjects with one (1) or more of the following: • Respiratory rate of > 30 bpm • Systolic blood pressure (SBP) 20 mg/day of prednisone or equivalent for more than 3 months before trial entry) • Splenectomized subjects or subjects with known hyposplenia or asplenia 11. Subjects who have been treated (> 24 hours) with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than IP during the trial period 12. Subjects who require parenteral antimicrobial therapy for the treatment of pneumonia 13. Subjects who have been hospitalized for > 48 hours for any cause within two weeks prior to trial entry 14. Subject has known renal insufficiency (calculated Creatinine Clearance [CrCl] < 30 mL/min) and/or severe hepatic insufficiency (Childs-Pugh Class C) 15. Subjects with life expectancy < 3 months 16. Subjects who have been previously treated under this Protocol 17. Subjects who are pregnant and/or breastfeeding 18. Subjects who have received any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the trial period) 19. Employees and/or family members of the Investigator or trial center with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To demonstrate the efficacy of faropenem medoxomil by establishing its non- inferiority to clarithromycin, in terms of clinical response rate, in the treatment of patients with CAP (community-acquired pneumonia) in the ITT (Intent to Treat) and modified Intent to Treat subjects mITT (modified Intent to Treat) populations - To evaluate the safety and tolerability profile of faropenem medoxomil 600 mg PO BID for 10 days in patients with CAP (community-acquired pneumonia);Secondary Objective: • To demonstrate the efficacy of faropenem medoxomil by establishing its non-inferiority to clarithromycin, in terms of clinical response rate, in the treatment of subjects with CAP in the CE and ME Populations • To demonstrate the efficacy of faropenem medoxomil by establishing its non-inferiority to clarithromycin, in terms of bacteriological response rate, in the treatment of subjects in the mITT and ME (Microbiologically Evaluable) Populations ;Primary end point(s): The primary analyses will be the comparison of the clinical response rates of faropenem medoxomil to clarithromycin at the Test-of-Cure visit in the ITT (Intent to Treat ) and mITT (modified Intent to Treat) Populations. A comparison of the incidence of adverse events for faropenem medoxomil and clarithromycin in the Intent-to-Treat (safety) Population. | — |
Countries
Germany
Outcome results
None listed