Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-03-03 @ 6:29 AM
Study NCT ID:
NCT01075204
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2010-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esther.oppermann@abbott.com', 'phone': '49 511 6750 3954', 'title': 'Esther Oppermann, Clinical Trial Manager', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '10 days', 'eventGroups': [{'id': 'EG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.', 'otherNumAtRisk': 335, 'otherNumAffected': 2, 'seriousNumAtRisk': 335, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 335, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 335, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Fast Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'All symptoms together [N=335]', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}]}]}, {'title': 'Fever response [N=184]', 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}]}]}, {'title': 'Cough response [N=215]', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}]}]}, {'title': 'Sputum response [N=212]', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}]}]}, {'title': 'Dyspnea response [N=62]', 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000'}]}]}, {'title': 'Abnormal breath sounds response [N=47]', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}]}]}, {'title': 'Rhinorrhea response [N=113]', 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}]}]}, {'title': 'Nasal congestion response [N=233]', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-nasal discharge response [N=178]', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}]}]}, {'title': 'Sneezing response [N=87]', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}]}]}, {'title': 'Sore throat response [N=200]', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}]}]}, {'title': 'Painful swallowing response [N=162]', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}]}]}, {'title': 'Itchy watery eye response [N=33]', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'Malaise response [N=68]', 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000'}]}]}, {'title': 'Myalgia response [N=79]', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 5', 'description': "Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment.\n\nData are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants. For the individual symptoms, N indicates the number of participants with that symptom at Baseline and with available recovery data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Treatment failure total', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}]}]}, {'title': 'All symptoms improved but not resolved', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Some symptoms improved and some resolved', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'Some symptoms resolved/improved, others unchanged', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Some symptoms resolved/improved/others worsened', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': 'Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms.\n\nParticipants with treatment failure were further categorized as:\n\n* All symptoms improved but not resolved within the study period;\n* Some symptoms improved and some resolved;\n* Some symptoms resolved or improved while other symptoms did not improve (unchanged);\n* Some symptoms resolved or improved while other symptoms became worse.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Factors Affecting the Speed of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '-0.007', 'groupId': 'OG000'}]}]}, {'title': 'Gender', 'categories': [{'measurements': [{'value': '0.216', 'groupId': 'OG000'}]}]}, {'title': 'Body mass index (BMI)', 'categories': [{'measurements': [{'value': '0.004', 'groupId': 'OG000'}]}]}, {'title': 'Tobacco use', 'categories': [{'measurements': [{'value': '0.419', 'groupId': 'OG000'}]}]}, {'title': 'Steroid use', 'categories': [{'measurements': [{'value': '-0.456', 'groupId': 'OG000'}]}]}, {'title': 'Bronchial asthma', 'categories': [{'measurements': [{'value': '0.140', 'groupId': 'OG000'}]}]}, {'title': 'Allergic rhinitis', 'categories': [{'measurements': [{'value': '19.292', 'groupId': 'OG000'}]}]}, {'title': 'Nasal septum deviation', 'categories': [{'measurements': [{'value': '18.698', 'groupId': 'OG000'}]}]}, {'title': 'Chronic obstructive pulmonary disease (COPD)', 'categories': [{'measurements': [{'value': '19.281', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.334', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Logistic regression: Omnibus Test of Model Coefficients (all the nine variables are considered together).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '9 degrees of freedom.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': 'Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.', 'unitOfMeasure': 'coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment.\n\nIf an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE):\n\nResults in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above.\n\nPlease see Adverse Events section below for more details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '83.28', 'upperLimit': '90.52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': 'Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients.'}, {'type': 'PRIMARY', 'title': 'Classification of Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Fast responders', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Slow responders', 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}]}]}, {'title': 'Failure response', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': "Based on the participant and physician's assessment, overall symptom response was classified as follows:\n\n* Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment.\n* Slow Responders: participants showing clinical recovery between Day 6 \\& Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms).\n* Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Fever Status at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'No fever', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': "Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Cough Status at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'No cough', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': "Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled patients with cough data available.'}, {'type': 'SECONDARY', 'title': 'Sputum Status at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'No sputum', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': "Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled patients with sputum data available.'}, {'type': 'SECONDARY', 'title': 'Dyspnea Status at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No dyspnea', 'categories': [{'measurements': [{'value': '273', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': "Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Abnormal Breathing Sounds Status at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'No abnormal breath sounds', 'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': "Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Rhinorrhea Status at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'No rhinorrhea', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': "Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Post-nasal Discharge Status at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': 'Resolved', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'No post-nasal discharge', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': "Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled patients with post-nasal discharge data available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Compliant With Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'classes': [{'title': '6 days', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': '7 days', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': '8 days', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 days', 'description': 'Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '335'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '335'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Clarithromycin Modified Release', 'description': 'Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.48', 'spread': '12.552', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age data provided for 330 participants.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}, {'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2010-02-23', 'resultsFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-20', 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Fast Recovery', 'timeFrame': 'Day 1 to Day 5', 'description': "Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment.\n\nData are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom."}, {'measure': 'Percentage of Participants With Clinical Success', 'timeFrame': '10 days', 'description': 'Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.'}, {'measure': 'Classification of Overall Response', 'timeFrame': '10 days', 'description': "Based on the participant and physician's assessment, overall symptom response was classified as follows:\n\n* Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment.\n* Slow Responders: participants showing clinical recovery between Day 6 \\& Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms).\n* Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms)."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Treatment Failure', 'timeFrame': '10 days', 'description': 'Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms.\n\nParticipants with treatment failure were further categorized as:\n\n* All symptoms improved but not resolved within the study period;\n* Some symptoms improved and some resolved;\n* Some symptoms resolved or improved while other symptoms did not improve (unchanged);\n* Some symptoms resolved or improved while other symptoms became worse.'}, {'measure': 'Factors Affecting the Speed of Recovery', 'timeFrame': '10 days', 'description': 'Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': '10 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment.\n\nIf an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE):\n\nResults in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above.\n\nPlease see Adverse Events section below for more details.'}, {'measure': 'Fever Status at End of Study', 'timeFrame': '10 days', 'description': "Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period."}, {'measure': 'Cough Status at End of Study', 'timeFrame': '10 days', 'description': "Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period."}, {'measure': 'Sputum Status at End of Study', 'timeFrame': '10 days', 'description': "Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period."}, {'measure': 'Dyspnea Status at End of Study', 'timeFrame': '10 days', 'description': "Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period."}, {'measure': 'Abnormal Breathing Sounds Status at End of Study', 'timeFrame': '10 days', 'description': "Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period."}, {'measure': 'Rhinorrhea Status at End of Study', 'timeFrame': '10 days', 'description': "Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period."}, {'measure': 'Post-nasal Discharge Status at End of Study', 'timeFrame': '10 days', 'description': "Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period."}, {'measure': 'Percentage of Participants Compliant With Treatment', 'timeFrame': '10 days', 'description': 'Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory Tract Infection', 'Clarithromycin', 'Recovery'], 'conditions': ['Respiratory Tract Infection']}, 'descriptionModule': {'briefSummary': 'The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Assignment to clarithromycin therapy falls within current clinical practice and was not decided in advance by this protocol. Study participants were selected from patients seen at the primary care clinic, with a preliminary clinical diagnosis of an upper or lower respiratory tract infection who were considered for antibiotic treatment and prescribed clarithromycin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, equal to or more than 18 years years of age\n* Patients with respiratory tract infections, including any of the following:\n\n * Acute tracheitis, acute tracheobronchitis\n * Acute sinusitis\n * Chronic sinusitis\n * Acute tonsillopharyngitis\n * Acute bronchitis\n * Mild community-acquired pneumonia\n * Acute exacerbation of chronic bronchitis\n\nExclusion Criteria:\n\n* Known hypersensitivity to or previously intolerant of macrolides.\n* Illness severe enough to warrant hospitalization or parenteral therapy.\n* Concomitant use of any of the following medications:\n\n * Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.\n * Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.\n * Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir.\n* Severe immunodeficiency and chronic disease conditions.\n* Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm).\n* Mental condition rendering the subject unable to understand the nature of the study.'}, 'identificationModule': {'nctId': 'NCT01075204', 'acronym': 'CLOSER', 'briefTitle': 'Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)', 'orgStudyIdInfo': {'id': 'P11-989'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clarithromycin modified release', 'description': 'Patients with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.', 'interventionNames': ['Drug: clarithromycin modified release 500 mg']}], 'interventions': [{'name': 'clarithromycin modified release 500 mg', 'type': 'DRUG', 'otherNames': ['Clarithromycin Modified Release 500 mg (Klacid XL)'], 'description': 'clarithromycin modified release 500 mg for 7 days', 'armGroupLabels': ['Clarithromycin modified release']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 50162', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 50215', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 50225', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 50235', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 50236', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 50237', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 51204', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 51205', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Helwan', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 50213', 'geoPoint': {'lat': 29.84144, 'lon': 31.30084}}, {'city': 'Tanta', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 51206', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'city': 'Tanta', 'country': 'Egypt', 'facility': 'Site Ref # / Investigator 51207', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'zip': '21461', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Site Ref # / Investigator 22543', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Mohamed Tahoun, Bachelor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Laboratories - Saudi Arabia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eilaf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}