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Acute Respiratory Infection | Middle Meatal Bacteriology During Acute Respiratory Infection in Children

Acute Respiratory Infection research study

What is the primary objective of this 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.

Who is eligible to participate?

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 InstituteĀ“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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Respiratory Infection

Sinusitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:placebomixture, 0.28125 ml/kg twice a day for 7 days

Drug:amoxicillin clavulanate acidmixture 0.28125 ml / kg twice a day for 7 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1placebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug

2amoxicillin-clavulanate acid

Study Status

Unknown status

Start Date: November 2007

Completed Date: December 2009

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.

Secondary Outcome: 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)

Study sponsors, principal investigator, and references

Principal Investigator: Jukka-Pekka Kuusiniemi, MD

Lead Sponsor: Oulu University Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00545961

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