A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis
- Conditions
- -J441 Chronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute exacerbation, unspecifiedJ441
- Registration Number
- PER-046-06
- Lead Sponsor
- REPLYDINE INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
a) Outpatients men and women who were not pregnant> 35 years of age with significant COPD, chronic cough and sputum production and acute exacerbation of chronic bronchitis.
b) Ex-smokers or smokers and / or present an obstruction in the
air flow.
c) Present a clinical diagnosis of AECB defined as.
d) The patient must provide a purulent or mucopurulent sputum by deep expectoration for a culture and susceptibility test on the day of enrollment in the study.
e) If a woman, the subject must: 1) Be postmenopausal for at least 1 year, or 2) Have had a hysterectomy and / or bilateral oophorectomy, or 3) Have had a bilateral tubal ligation or otherwise be disabled to get pregnant.
f) If the subject is of fertile potential, they must: 1) Have maintained their normal menstrual pattern during the 3 months prior to admission to the study AND 2) have taken hormonal contraceptives for at least 1 month before entering the study, or agree to use a spermicide and barrier methods or use another acceptable method of contraception and agree to continue its use during the study AND 3) Have had a pregnancy test of subunit B of hCG negative.
g) The women subjects who will be pregnant during their participation should be withdrawn from the trial immediately.
h) Read and sign the Informed Consent and, if applicable, the California Bill of Rights.
i) The subject is an appropriate candidate for oral antibacterial therapy.
a) History of hypersensitivity to faropenem medoxomil or to any of the components of the product or a history of an anaphylactic reaction to beta-lactamases.
b) History of hypersensitivity to telithromycin or to any member of the macrolide antimicrobial agents.
c) Chest x-ray and other radiographic documentation of an underlying pneumonia.
d) Known malignancy of the active thoracic or pulmonary cavity within the last 5 years.
e) Known concurrent active medical charts that could interfere with the effectiveness evaluation.
f) Neutropenia, or CD4 count <200 cells / mm3 or under highly active antiretroviral therapy (HAART). An HIV test is not necessary.
g) Need for hospitalization or administration of intravenous antibiotics because of the present exacerbation.
h) Hospitalization for any reason within the two weeks prior to admission to the study, for ≥ 48 hours.
i) Any previous treatment of a systemic antibacterial agent within the last 2 weeks.
j) Subjects under concomitant therapy with one or more of the following medications: Class lA or Class III antiarrhythmic agents, HMG-CoA reductase inhibitors, rifampin, phenytoin, carbamazepine, phenobarbital, cisapride, pimozide, ergotamine or dihydroergotamine.
k) Subjects with heart failure under treatment with metoprolol.
l) Subjects with severe renal insufficiency and / or liver failure
severe
m) Prior treatment under this Protocol.
n) The subject is pregnant or breast-feeding.
o) Have received an experimental drug or medical device within the last 30 days.
p) Employees and / or family members of the researcher or study center with direct participation in the proposed study or another study under the direction of that researcher or study center.
q) Patients with a family or personal history of QTc prolongation or proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, or clinically significant bradycardia.
r) Patients with myasthenia gravis.
s) Patients with a history of hepatitis / jaundice associated with the use of telithromycin (KETEK)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation in which it will be defined:<br>1) Clinical cure: Resolution or improvement in the signs and symptoms with return of the subject to the base state. No additional antimicrobial therapy is necessary for AECB.<br>2) Clinical failure: the symptoms of the subject did not improve or worsened in such a way that it is necessary to provide an additional or alternative therapy for the AECB.<br>Measure:Clinical response rates of faropenem medoxomil with placebo during the visit of the Healing Test.<br><br>Timepoints:Days 8-12.<br>
- Secondary Outcome Measures
Name Time Method