None listed
Conditions
Interventions
GROUP 1 Type of group
This group is treated with Faropenem Medoxomil 600 mg PO, BID + Telithromycin Placebo 400 mg PO QD
This group is treated with Faropenem Medoxomil Placebo 300 mg PO, BID + Telithromycin Placebo 400 mg PO QD
Sponsors
REPLYDINE INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 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 g) The women subjects who will be pregnant during their participation should be withdrawn from the trial immediately.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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation in which it will be defined: 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. 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. Measure:Clinical response rates of faropenem medoxomil with placebo during the visit of the Healing Test. Timepoints:Days 8-12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation in which it will be defined: 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. 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. Measure:Clinical response rates of faropenem medoxomil with telithromycin during the visit of the Healing Test. Timepoints:Days 8-12. ; Outcome name:Specifically, Gastrointestinal Disorder events with MedDRA Preferred Terms will be evaluated, including nausea, vomiting, diarrhea, loose stools, aggravated diarrhea, hemorrhagic diarrhea, diarrhea not otherwise specified, liquid stools. Measure:Incidence of adverse events of faropenem medoxomil and telithromycin. Timepoints:Days 3 to 5 in office visit, 2 to 5 through telephone contact, 8 to 12 (healing test) and 19 to 33 (Long-term follow-up). ; Outcome name:The clinical response is measured by clinical signs and symptoms, purulence and sputum volume. Measure: 695/5000 1) Clinical response in the Visit of the TOC in the population with Intent to Treat (ITT). 2) Clinical Response in Telephone Contact During Therapy between the treatment groups in the clinically evaluable population. 3) Clinical response in the Long-Term Follow-up Visit after the Therapy in the clinically evaluable population. 4) Microbiological response in the population visit of the Healing Test microbiologically valid. Timepoints:Visit of the TOC: Days 8-12. Telephone contact during therapy: Days 2-5. Long-term follow-up visit: days 19-33 | — |
Countries
Bulgaria, Italy, Latovia, Peru
Outcome results
None listed