Middle Meatal Bacteriology During Acute Respiratory Infection in Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Oulu University Hospital.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Oulu University Hospital
Information provided by:
Oulu University Hospital
ClinicalTrials.gov Identifier:
NCT00545961
First received: October 17, 2007
Last updated: October 18, 2007
Last verified: October 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Respiratory Infection Sinusitis |
Drug: placebo Drug: amoxicillin clavulanate acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study |
Resource links provided by NLM:
Further study details as provided by Oulu University Hospital:
Primary Outcome Measures:
- Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry. [ Time Frame: within the first 3 weeks after enrolment ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug
|
Drug: placebo
mixture, 0.28125 ml/kg twice a day for 7 days
Other Name: Ora-Plus (registered trademark) mixture
|
|
Active Comparator: 2
amoxicillin-clavulanate acid
|
Drug: amoxicillin clavulanate acid
mixture 0.28125 ml / kg twice a day for 7 days
Other Name: Clavurion mixture (Orion Oy)
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 6 Years to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545961
Contacts
| Contact: Aila A Kristo, MD | +35883153492 | aila.kristo@ppshp.fi |
| Contact: Olli-Pekka Alho, MD | +35883153473 | olli-pekka.alho@oulu.fi |
Locations
| Finland | |
| Keski-pohjanmaan keskussairaala | Not yet recruiting |
| Kokkola, Finland | |
| Sub-Investigator: Eeva Löfgren, MD | |
| Oulu University Hospital | Not yet recruiting |
| Oulu, Finland | |
| Principal Investigator: Aila Kristo, MD | |
| Sub-Investigator: Anna Marttila, MD | |
| Sub-Investigator: Ulla Lantto, MD | |
| Etelä-Pohjanmaan Keskussairaala | Not yet recruiting |
| Seinäjoki, Finland | |
| Sub-Investigator: Jukka-Pekka Kuusiniemi, MD | |
Sponsors and Collaborators
Oulu University Hospital
Investigators
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00545961 History of Changes |
| Other Study ID Numbers: | Diary nr 41/2007 |
| Study First Received: | October 17, 2007 |
| Last Updated: | October 18, 2007 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by Oulu University Hospital:
|
respiratory infection sinusitis rhinosinusitis children middle meatal specimens |
respiratory track bacteria amoxicillin-clavulanate pneumococci haemophilus moraxella |
Additional relevant MeSH terms:
|
Respiratory Tract Infections Sinusitis Infection Respiratory Tract Diseases Paranasal Sinus Diseases Nose Diseases Otorhinolaryngologic Diseases Amoxicillin Amoxicillin-Potassium Clavulanate Combination |
Clavulanic Acids Clavulanic Acid Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012
