Middle Meatal Bacteriology During Acute Respiratory Infection in Children

NCT00545961 | Unknown Phase 4

• 1 other identifier: Diary nr 41/2007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Respiratory Infection; Sinusitis

Keywords

respiratory infection; sinusitis; rhinosinusitis; children; middle meatal specimens; respiratory track bacteria; amoxicillin-clavulanate; pneumococci; haemophilus; moraxella

Outcome Measures

Primary Outcomes (1)

• Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.

  within the first 3 weeks after enrolment

Secondary Outcomes (3)

• 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

Study Arms (2)

1

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

Drug: placebo

2

ACTIVE COMPARATOR

amoxicillin-clavulanate acid

Drug: amoxicillin clavulanate acid

Interventions

placebo DRUG

mixture, 0.28125 ml/kg twice a day for 7 days

Also known as: Ora-Plus (registered trademark) mixture

1

amoxicillin clavulanate acid DRUG

mixture 0.28125 ml / kg twice a day for 7 days

Also known as: Clavurion mixture (Orion Oy)

2

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oulu University Hospital: lead

Study Sites (3)

Keski-pohjanmaan keskussairaala

Kokkola, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Etelä-Pohjanmaan Keskussairaala

Seinäjoki, Finland

Location

MeSH Terms

Conditions

Sinusitis; Respiratory Tract Infections; Rhinosinusitis; Haemophilus Infections

Condition Hierarchy (Ancestors)

Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Olli-Pekka Alho, professor

  Dept of Otolaryngology, University of Oulu, Finland

  STUDY DIRECTOR

• Aila Kristo, MD

  Dept of Otolaryngology, University of Oulu, Finland

  STUDY DIRECTOR

• Ulla Lantto, MD

  Dept of Otolaryngology, University of Oulu, Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aila A Kristo, MD

CONTACT

+35883153492; aila.kristo@ppshp.fi

Olli-Pekka Alho, MD

CONTACT

+35883153473; olli-pekka.alho@oulu.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 18, 2007
• Study Start: November 1, 2007
• Study Completion: December 1, 2009
• Last Updated: October 19, 2007

Record last verified: 2007-10

Locations

FI (3)