Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-05 @ 1:44 AM
Study NCT ID:
NCT00545961
Status:
UNKNOWN
Last Update Posted:
2007-10-19
First Post:
2007-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Middle Meatal Bacteriology During Acute Respiratory Infection in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D000096825', 'term': 'Rhinosinusitis'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-10-18', 'studyFirstSubmitDate': '2007-10-17', 'studyFirstSubmitQcDate': '2007-10-17', 'lastUpdatePostDateStruct': {'date': '2007-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.', 'timeFrame': 'within the first 3 weeks after enrolment'}], 'secondaryOutcomes': [{'measure': 'duration (days)and severity (grade mild, severe) of different symptoms (clear nasal discharge, coloured nasal discharge, nasal obstruction, cough, throat pain, ear ache, fever, headache, diarrhea)', 'timeFrame': 'within the first three weeks after enrolment'}, {'measure': 'number of days the child is using the following symptomatic drugs (pain killers, nasal vasoconstrictors, nasal corticosteroids, asthma drugs, antihistamines)', 'timeFrame': 'within the first three weeks after the enrolment'}, {'measure': 'number of days the child is not at school and that the parents are not at work', 'timeFrame': 'within the first three weeks after enrolment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['respiratory infection', 'sinusitis', 'rhinosinusitis', 'children', 'middle meatal specimens', 'respiratory track bacteria', 'amoxicillin-clavulanate', 'pneumococci', 'haemophilus', 'moraxella'], 'conditions': ['Acute Respiratory Infection', 'Sinusitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether the children with respiratory infection and the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus benefit from antimicrobial treatment.', 'detailedDescription': 'Acute sinusitis is one of the most common disease in children requiring antimicrobial treatment. The diagnosis and treatment outcomes of acute sinusitis are contradictory, and better diagnostic criteria are needed. In adults with acute maxillary sinusitis, bacterial culture results obtained from the nasal middle meatus are comparable to those obtained from sinus puncture and aspiration. In children, the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus during respiratory infection predicts longer duration of signs and symptoms of common cold.\n\nIn this randomized placebo-controlled study, the effect of the antimicrobial treatment (amoxicillin-clavulanate) is examined in children with pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus during respiratory infection. The duration of the symptoms and speed of recovery is recognized by daily symptom-diary, the results are compared between the treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute respiratory infection with nasal symptoms (nasal obstruction or discharge)\n* seeking medical help from health centre for the respiratory symptoms\n* pathogenic bacteria (S pneumoniae, H influenzae or M catarrhalis) identified from right or left nasal middle meatus in the endoscopically taken swab culture sampling taken by a study investigator (all microbiological analyses are done by the National Public Health Institute´s microbiological laboratory in Oulu)\n\nExclusion Criteria:\n\n* otitis, tonsillitis or other disease requiring antimicrobial treatment\n* respiratory infection within 4 weeks of screening\n* antimicrobial treatment within 4 weeks of screening\n* allergy to penicillin or amoxicillin'}, 'identificationModule': {'nctId': 'NCT00545961', 'briefTitle': 'Middle Meatal Bacteriology During Acute Respiratory Infection in Children', 'organization': {'class': 'OTHER', 'fullName': 'Oulu University Hospital'}, 'officialTitle': 'Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study', 'orgStudyIdInfo': {'id': 'Diary nr 41/2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'amoxicillin-clavulanate acid', 'interventionNames': ['Drug: amoxicillin clavulanate acid']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Ora-Plus (registered trademark) mixture'], 'description': 'mixture, 0.28125 ml/kg twice a day for 7 days', 'armGroupLabels': ['1']}, {'name': 'amoxicillin clavulanate acid', 'type': 'DRUG', 'otherNames': ['Clavurion mixture (Orion Oy)'], 'description': 'mixture 0.28125 ml / kg twice a day for 7 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kokkola', 'country': 'Finland', 'contacts': [{'name': 'Eeva Löfgren, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Keski-pohjanmaan keskussairaala', 'geoPoint': {'lat': 63.83847, 'lon': 23.13066}}, {'city': 'Oulu', 'country': 'Finland', 'contacts': [{'name': 'Aila Kristo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anna Marttila, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ulla Lantto, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Seinäjoki', 'country': 'Finland', 'contacts': [{'name': 'Jukka-Pekka Kuusiniemi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Etelä-Pohjanmaan Keskussairaala', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}], 'centralContacts': [{'name': 'Aila A Kristo, MD', 'role': 'CONTACT', 'email': 'aila.kristo@ppshp.fi', 'phone': '+35883153492'}, {'name': 'Olli-Pekka Alho, MD', 'role': 'CONTACT', 'email': 'olli-pekka.alho@oulu.fi', 'phone': '+35883153473'}], 'overallOfficials': [{'name': 'Jukka-Pekka Kuusiniemi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Otolaryngology, Seinäjoki Central Hospital, Finland'}, {'name': 'Eeva Löfgren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Otolaryngology, Kokkola Central Hospital, Finland'}, {'name': 'Anna Marttila, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}, {'name': 'Olli-Pekka Alho, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}, {'name': 'Aila Kristo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}, {'name': 'Ulla Lantto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Otolaryngology, University of Oulu, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oulu University Hospital', 'class': 'OTHER'}}}}