Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00261105
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2005-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telithromycin in Respiratory Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106791', 'term': 'telithromycin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-24', 'studyFirstSubmitDate': '2005-12-01', 'studyFirstSubmitQcDate': '2005-12-01', 'lastUpdatePostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Outcome (Global Assessment by the participating physicians)', 'timeFrame': 'During the Study Conduct'}], 'secondaryOutcomes': [{'measure': 'Rate at which additional antibacterials were prescribed to treat the primary infection', 'timeFrame': 'During the study conduct'}, {'measure': 'Rate of hospitalisation due to a complication of the primary infection', 'timeFrame': 'During the study conduct'}, {'measure': 'Assessment of chest X-ray and sinus X-ray if available.', 'timeFrame': 'During the study conduct'}, {'measure': 'Adverse Event (AE) and Serious Adverse Event (SAE) reported', 'timeFrame': 'from the inform consent signed up to the end of the study'}]}, 'conditionsModule': {'conditions': ['Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n* The primary objective of the study is to evaluate clinical efficacy i.e. to show that with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community acquired respiratory tract infections: community acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in outpatients.\n\nSecondary Objectives:\n\nThe secondary objectives are to:\n\n* Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which additional antibacterials were prescribed to treat the primary infection; the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data, chest X-ray and sinus X-ray if available.\n* Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral Conditions\n\n* Outpatients\n* Fulfillment of clinical diagnostic criteria for one of the following indications:\n\n * Mild to moderate Community Acquired Pneumonia (CAP)\n * Acute bacterial Exacerbation of Chronic Bronchitis (AECB)\n * Acute Sinusitis (AS)\n\nFor CAP\n\nThe Criteria to be fulfilled are:\n\n* New onset of at least two of the following:\n\n * Cough\n * Production of purulent sputum\n * Auscultatory findings compatible with pneumonia, e.g. rales, evidence of pulmonary consolidation\n * Dyspnea or tachypnea\n * Fever\n * Elevated total white blood cell count \\> 10 000/mm3 or \\>15% bands regardless of total count\n* Chest X-ray findings supporting a clinical diagnosis of bacterial pneumonia (e.g. new infiltrate)\n\nFor AECB\n\nThe Criteria to be fulfilled are:\n\n* Chronic bronchitis defined as cough and excessive sputum production for more than 2 consecutive years and on most days in a 3-month consecutive period.\n* Exacerbation defined by:\n\n * Increase in sputum purulence, or\n * Increase in sputum volume, or\n * Increase in dyspnea\n\nFor AS\n\nThe criteria to be fulfilled are:\n\nAt least two of the major or one major and two minor factors listed below, for more than one week and less than 4 weeks:\n\n* Major factors:\n\n * Facial pressure and/or pain\n * Facial congestion or fullness\n * Nasal obstruction\n * Nasal purulence or postnasal discharge\n * Hyposmia or anosmia\n * Fever\n* Minor factors:\n\n * Headache\n * Halitosis\n * Fatigue\n * Dental pain\n * Cough\n * Ear pain, pressure or fullness\n\nExclusion Criteria:\n\nGeneral Conditions\n\nSubjects presenting with any of the following will not be included in the study:\n\n* Treatment required during the study with ergot alkaloid derivatives, pimozide, astemizole, terfenadine, cisapride, simvastatin, atorvastatin and lovastatin, and the oral use of the benzodiazepines midazolam, triazolam and alprazolam.\n* History of congenital or family history of long QT syndrome (if not excluded by ECG) or known acquired QT interval prolongation.\n* Known hypersensitivity to telithromycin or to macrolide antibiotics.\n* Hospital acquired infections (hospitalization for more than 72 hours within 7 days of study entry).\n* Pregnant or breast-feeding women. For the women of childbearing potential it is left to the investigators discretion to establish a lack of pregnancy, e.g. with contraceptive use, menstrual pattern, urinary pregnancy test.\n* Subjects with severely impaired renal function (creatinine clearance \\<30 ml/min).\n* Subjects that had received anti-bacterials for more than 24 hours within 7 days prior to enrollment in the study, unless the treatment has failed.\n* Subjects receiving medications, including other anti-microbials or anti-cancer drugs, that could interfere with the evaluation.\n* Microbiologically documented infection with a pathogen known prior to inclusion to be resistant to the study medications.\n* Infection, other than the primary infection for which the subject is being included in the study that requires use of other systemic anti-bacterial drug.\n* Splenectomised subjects.\n* Use of Ketek® (telithromycin) or participation in a study using Ketek® (telithromycin) in the previous 30 calendar days.\n* Subjects that have received any investigational drug within 4 weeks of enrollment in the study.\n* No subject will be allowed to enroll in this study more than once.\n\nFor CAP\n\nAdditional exclusion criteria are:\n\n* Severe pneumonia defined by any one of the following:\n\n * Judged as needing Intensive Care Unit admission.\n * Need of parenteral antibiotic treatment (if the attending physician wants to prescribe a parenteral treatment for adherence reasons or local prescription habits this is accepted, provided that the patient does not have a severe pneumonia).\n * Acute respiratory failure or requirement for mechanical ventilation.\n * Altered mental status resulting from the infective process.\n * Resting respiratory rate \\> 30 breaths/min.\n * Chest X-ray showing increase in opacity by \\> 50% within 48 hours of current evaluation.\n* Total white blood cell count \\< 4 000/mm3.\n* Aspiration pneumonia.\n* Pneumonia suspected to be non-bacterial (due to fungus or viral).\n* Subjects suffering from severe bronchiectasis (production of more than 125 mL of sputum/day), cystic fibrosis, active tuberculosis, pulmonary infarction or embolism, bronchial obstruction, lung cancer or lung metastasis, lung abscess, extra-pulmonary extension (like meningitis, septic arthritis, endocarditis).\n\nFor AECB\n\nAdditional exclusion criteria are:\n\n* Need of parenteral antibiotic treatment (if the attending physician wants to prescribe a parenteral treatment for adherence reasons or local prescription habits this is accepted, provided that the patient does not have a severe infection).\n* Acute respiratory failure (respiratory distress, hypercarbia, worsening hypoxemia) or requirement for mechanical ventilation.\n* Severe bronchiectasis, cystic fibrosis, active tuberculosis, pulmonary infarction or embolism, bronchial obstruction, lung cancer or lung metastasis, lung abscess.\n\nFor AS\n\nAdditional exclusion criteria are:\n\n* Need of immediate surgery for the treatment of AS.\n* Chronic sinusitis (symptoms lasting more than 4 weeks).\n* Recurrent sinusitis (4 or more episodes of sinusitis requiring antibiotic therapy in the previous 12 months).\n* Nosocomial acquired sinusitis.\n* Cystic fibrosis, immotile cilia syndrome.\n* Obstructive lesions in nasopharynx (e.g. polyps, tumor).\n* Use of nasal, nasogastric or nasotracheal catheters.'}, 'identificationModule': {'nctId': 'NCT00261105', 'briefTitle': 'Telithromycin in Respiratory Tract Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open, Multicenter, Non-comparative, Phase IV Trial of Efficacy and Safety of Ketek(Telithromycin) 800mg', 'orgStudyIdInfo': {'id': 'HMR3647A_4026'}}, 'armsInterventionsModule': {'interventions': [{'name': 'telithromycin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Won-Sik Lee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}