Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 10 Days Versus Clarithromycin in the Treatment of Community-Acquired Pneumonia”
- Conditions
- 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: 9.1Level: LLTClassification code 10010120Term: Community acquired pneumonia
- Registration Number
- EUCTR2007-003854-28-DE
- Lead Sponsor
- Replidyne, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 770
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 <10 squamous epithelial cells/LPF) and purulent (i.e., cloudy and discolored) sputum specimen
4.A CXR obtained within 24 hours prior to initiating IP therapy and showing the presence of a new or progressive pulmonary infiltrate(s)
5.The presence of one (1) or more of the following clinical findings:
•New or increased cough
•Dyspnea or tachypnea (RR > 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NOTE:Female subjects who have a positive pregnancy test and become pregnant during the trial must be promptly withdrawn from the trial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
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) < 90 mm Hg or diastolic blood pressure (DBP) < 60 mm Hg
•Altered mental status (e.g., new disorientation to person, place or time, lethargy, stupor, coma)
•Require mechanical ventilation
•Require vasopressors to maintain blood pressure or urinary output
4.Subjects with known bronchial obstruction or a history of post-obstructive pneumonia (does not exclude subjects with COPD)
5.Subjects with known primary or metastatic malignancy in lung and/or pleura within the past 5 years
6.Subjects with known or suspected bronchiectasis, cystic fibrosis, lung abscess, empyema, aspiration pneumonia, acute pulmonary embolism or collagen vascular disease affecting the lungs
7.Subjects with known or suspected HIV infection, opportunistic infections such as toxoplasmosis, cryptococcal meningitis, tuberculosis, histoplasmosis, Pneumocystis jiroveci pneumonia, cytomegalovirus infection, oropharyngeal candidiasis (thrush), cryptosporidiosis, Mycobacterium avium complex infection, Kaposi’s sarcoma
8.Subjects with known underlying condition(s) or disease(s) that would interfere with oral absorption of the IP
9.Subjects residing in a long-term care facility within 4 weeks of the start of the IP (e.g., nursing home, etc.)
10.Immunocompromised subjects, including but not limited to subjects with:
•Known WBC count (< 2000 cells/mm3) or CD4 count of < 200 cells/mm3, or on highly active antiretroviral therapy. An HIV test is not required
•Chronic corticosteroid therapy (> 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method