Sinusitis Clinical Trial
Official title:
Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study
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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 13 Years |
Eligibility |
Inclusion Criteria: - acute respiratory infection with nasal symptoms (nasal obstruction or discharge) - seeking medical help from health centre for the respiratory symptoms - 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 InstituteĀ“s microbiological laboratory in Oulu) Exclusion Criteria: - otitis, tonsillitis or other disease requiring antimicrobial treatment - respiratory infection within 4 weeks of screening - antimicrobial treatment within 4 weeks of screening - allergy to penicillin or amoxicillin |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Keski-pohjanmaan keskussairaala | Kokkola | |
Finland | Oulu University Hospital | Oulu | |
Finland | Etelä-Pohjanmaan Keskussairaala | Seinäjoki |
Lead Sponsor | Collaborator |
---|---|
Oulu University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry. | within the first 3 weeks after enrolment | ||
Secondary | 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) | within the first three weeks after enrolment | ||
Secondary | number of days the child is using the following symptomatic drugs (pain killers, nasal vasoconstrictors, nasal corticosteroids, asthma drugs, antihistamines) | within the first three weeks after the enrolment | ||
Secondary | number of days the child is not at school and that the parents are not at work | within the first three weeks after enrolment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03584178 -
The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT06016335 -
MRI-based Synthetic CT Images of the Head and Neck
|
N/A | |
Active, not recruiting |
NCT02278484 -
Sinus Balloon Dilation in Pediatric Patients
|
N/A | |
Withdrawn |
NCT02071667 -
Association of Periostin Levels and Chronic Sinusitis
|
N/A | |
Completed |
NCT01420471 -
Medicated Punctured-Glove-Finger Spacer Study
|
Phase 4 | |
Completed |
NCT01118312 -
Study of Asthma and Nasal Steroids
|
Phase 4 | |
Completed |
NCT00645762 -
Balloon REmodeling Antrostomy THErapy Study
|
Phase 2 | |
Completed |
NCT01685229 -
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
|
||
Active, not recruiting |
NCT03943121 -
The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
|
N/A | |
Withdrawn |
NCT02900794 -
Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery
|
N/A | |
Terminated |
NCT02630472 -
Topical Irrigation Therapy for CRS
|
Phase 1/Phase 2 | |
Completed |
NCT01442740 -
15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients
|
N/A | |
Completed |
NCT01001039 -
Validation of the Facial and Cephalic Pain Inventory
|
N/A | |
Completed |
NCT01033799 -
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
|
N/A | |
Completed |
NCT00242437 -
Hemostatic Matrix in Endoscopic Sinus Surgery
|
Phase 4 | |
Completed |
NCT00335309 -
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT00236522 -
A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.
|
Phase 3 | |
Completed |
NCT01717274 -
Hot Saline Irrigation Study
|
N/A | |
Completed |
NCT01166945 -
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
|
N/A | |
Completed |
NCT00747747 -
Sinuclean's Treatment Of Sinusitis' Symptoms
|
Phase 4 |