Acute Respiratory InfectionPhase 4NCT00545961
Middle Meatal Bacteriology During Acute Respiratory Infection in Children
A Phase 4 study testing amoxicillin clavulanate acid in people with Acute Respiratory Infection and Sinusitis, run by Oulu University Hospital at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Acute Respiratory Infection, Sinusitis
- What is being tested?
- amoxicillin clavulanate acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesFinland
- Study dates
- Nov 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Keski-pohjanmaan keskussairaala
Kokkola
Eeva Löfgren, MD
Oulu University Hospital
Oulu
Aila Kristo, MD
Anna Marttila, MD
Etelä-Pohjanmaan Keskussairaala
Seinäjoki
Jukka-Pekka Kuusiniemi, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Infection, Sinusitis
- Being tested
- placebo, amoxicillin clavulanate acid
- Keywords
- respiratory infection, sinusitis, rhinosinusitis, children, middle meatal specimens, respiratory track bacteria, amoxicillin-clavulanate, pneumococci, haemophilus, moraxella
- Medical subject headings
- Sinusitis, Respiratory Tract Infections, Rhinosinusitis, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called Ora-Plus (registered trademark) mixture
mixture, 0.28125 ml/kg twice a day for 7 days
amoxicillin clavulanate acidDrug
Also called Clavurion mixture (Orion Oy)
mixture 0.28125 ml / kg twice a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: placebo |
| 2 | Active comparator | amoxicillin-clavulanate acid Receives: Drug: amoxicillin clavulanate acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.
Measured: 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)
Measured: 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)
Measured: 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
Measured: within the first three weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startNov 2007
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jukka-Pekka Kuusiniemi, MD, Principal investigator, Dept of Otolaryngology, Seinäjoki Central Hospital, FinlandEeva Löfgren, MD, Principal investigator, Dept of Otolaryngology, Kokkola Central Hospital, FinlandAnna Marttila, MD, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandOlli-Pekka Alho, professor, Study director, Dept of Otolaryngology, University of Oulu, FinlandAila Kristo, MD, Study director, Dept of Otolaryngology, University of Oulu, FinlandUlla Lantto, MD, Principal investigator, Dept of Otolaryngology, University of Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545961
- Sponsor's protocol ID
- Diary nr 41/2007
- Status last verified
- Oct 2007
- First submitted
- 17 Oct 2007
- Last updated
- 19 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study
- ClinicalTrials.gov ID
- NCT00545961
- Acronym / sponsor ID
- Diary nr 41/2007
- Conditions
- Acute Respiratory Infection, Sinusitis
- Keywords
- respiratory infection, sinusitis, rhinosinusitis, children, middle meatal specimens, respiratory track bacteria, amoxicillin-clavulanate, pneumococci
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Dec 2009 (estimated)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboplacebo Ora-Plus (registered trademark) mixture with an strawberry sweetening agent to make the placebo mixture similar in appearance and taste to active drug |
| 2 | Active comparator | Drug: amoxicillin clavulanate acidamoxicillin-clavulanate acid |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: Ora-Plus (registered trademark) mixturemixture, 0.28125 ml/kg twice a day for 7 days | Drug | 1 |
| amoxicillin clavulanate acidAlso: Clavurion mixture (Orion Oy)mixture 0.28125 ml / kg twice a day for 7 days | Drug | 2 |
Primary outcome
Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry.
Time frame: within the first 3 weeks after enrolment
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jukka-Pekka Kuusiniemi, MD principal investigator
Dept of Otolaryngology, Seinäjoki Central Hospital, Finland
Eeva Löfgren, MD principal investigator
Dept of Otolaryngology, Kokkola Central Hospital, Finland
Anna Marttila, MD principal investigator
Dept of Otolaryngology, University of Oulu, Finland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amoxicillin clavulanate acid in people with Acute Respiratory Infection and Sinusitis, run by Oulu University Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aila A Kristo, MD (+35883153492, aila.kristo@ppshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry. (time frame: within the first 3 weeks after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2007.