Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Full Text View

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 IV

MedlinePlus related topics:

Sinusitis

ChemIDplus related topics:

Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Amoxicillin-potassium clavulanate combination Clavulanic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study

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
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 mixture, 0.28125 ml/kg twice a day for 7 days
2: Active Comparator amoxicillin-clavulanate acid	Drug: amoxicillin clavulanate acid mixture 0.28125 ml / kg twice a day for 7 days

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
	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
	Keski-pohjanmaan keskussairaala	Not yet recruiting
	Kokkola, Finland
	Sub-Investigator: Eeva Löfgren, 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

Study ID Numbers:	Diary nr 41/2007
First Received:	October 17, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00545961
Health Authority:	Finland: National Agency for Medicines

Keywords provided by Oulu University Hospital:

respiratory infection

sinusitis

rhinosinusitis

children

middle meatal specimens

respiratory track bacteria

amoxicillin-clavulanate

pneumococci

haemophilus

moraxella

Study placed in the following topic categories:

Amoxicillin

Otorhinolaryngologic Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Clavulanic Acid

Clavulanic Acids

Sinusitis

Amoxicillin-Potassium Clavulanate Combination

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Communicable Diseases

Molecular Mechanisms of Pharmacological Action

Paranasal Sinus Diseases

Therapeutic Uses

Enzyme Inhibitors

Infection

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Oulu University Hospital
Information provided by:	Oulu University Hospital
ClinicalTrials.gov Identifier:	NCT00545961