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.

Study Overview

• Status: Unknown
• Conditions: Sinusitis; Acute Respiratory Infection
• Intervention / Treatment: Drug: placebo; Drug: amoxicillin clavulanate acid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Kokkola, Finland
    • Keski-Pohjanmaan keskussairaala
  • Oulu, Finland
    • Oulu University Hospital
  • Seinäjoki, Finland
    • Etelä-Pohjanmaan Keskussairaala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Clavurion mixture (Orion Oy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.	within the first 3 weeks after enrolment

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
number of days the child is not at school and that the parents are not at work	within the first three weeks after enrolment

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: October 17, 2007
• First Posted (Estimate): October 18, 2007

Study Record Updates

• Last Update Posted (Estimate): October 19, 2007
• Last Update Submitted That Met QC Criteria: October 18, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: children; respiratory infection; sinusitis; rhinosinusitis; pneumococci; amoxicillin-clavulanate; middle meatal specimens; respiratory track bacteria; haemophilus; moraxella
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Infections; Communicable Diseases; Sinusitis; Respiratory Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: Diary nr 41/2007