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Middle Meatal Bacteriology During Acute Respiratory Infection in Children
This study is not yet open for participant recruitment.
Study NCT00545961   Information provided by Oulu University Hospital
First Received: October 17, 2007   Last Updated: October 18, 2007   History of Changes

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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
Contact: Aila A Kristo, MD +35883153492 aila.kristo@ppshp.fi
Contact: Olli-Pekka Alho, MD +35883153473 olli-pekka.alho@oulu.fi
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP