| October 17, 2007 |
| October 18, 2007 |
| November 2007 |
| |
| Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry. [ Time Frame: within the first 3 weeks after enrolment ] |
| Same as current |
| Complete list of historical versions of study NCT00545961 on ClinicalTrials.gov Archive Site |
- 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) [ Time Frame: within the first three weeks after enrolment ]
- number of days the child is using the following symptomatic drugs (pain killers, nasal vasoconstrictors, nasal corticosteroids, asthma drugs, antihistamines) [ Time Frame: within the first three weeks after the enrolment ]
- number of days the child is not at school and that the parents are not at work [ Time Frame: within the first three weeks after enrolment ]
|
| Same as current |
| |
| Middle Meatal Bacteriology During Acute Respiratory Infection in Children |
| 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. |
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.
In 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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Acute Respiratory Infection
- Sinusitis
|
- Drug: placebo
- Drug: amoxicillin clavulanate acid
|
- Placebo Comparator: placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug
- Active Comparator: amoxicillin-clavulanate acid
|
| |
| |
| Not yet recruiting |
| 120 |
| December 2009 |
|
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 Institute´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
|
| Both |
| 6 Years to 13 Years |
| No |
|
|
| Finland |
| |
| NCT00545961 |
|
| Diary nr 41/2007 |
| Oulu University Hospital |
|
| Principal Investigator: |
Jukka-Pekka Kuusiniemi, MD |
Dept of Otolaryngology, Seinäjoki Central Hospital, Finland |
|
| Principal Investigator: |
Eeva Löfgren, MD |
Dept of Otolaryngology, Kokkola Central Hospital, Finland |
|
| Principal Investigator: |
Anna Marttila, MD |
Dept of Otolaryngology, University of Oulu, Finland |
|
| Study Director: |
Olli-Pekka Alho, professor |
Dept of Otolaryngology, University of Oulu, Finland |
|
| Study Director: |
Aila Kristo, MD |
Dept of Otolaryngology, University of Oulu, Finland |
|
| Principal Investigator: |
Ulla Lantto, MD |
Dept of Otolaryngology, University of Oulu, Finland |
|
|
| Oulu University Hospital |
| October 2007 |