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Acute Otitis MediaPhase 4NCT00299455

Amoxicillin Clavulanate in Treatment of Acute Otitis Media

A Phase 4 study testing amoxicillin-clavulanate in people with Acute Otitis Media, run by University of Turku at 2 sites in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). Read more about this study

Who is it for?
Ages 6 to 35 months
Conditions the study is for
Acute Otitis Media
What is being tested?
amoxicillin-clavulanate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
2 sitesFinland
Study dates
Mar 2006to Mar 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 35 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Acute otitis media
  • Age 6 - 35 mo

Who cannot join

  • Spontaneous perforation of the tympanic membrane and drainage
  • Systemic or nasal corticosteroid therapy within 3 preceding days
  • Antihistamine therapy with 3 preceding days
  • Oseltamivir therapy within 3 preceding days
  • Allergy to amoxicillin/penicillin
  • Tympanostomy tube present in tympanic membrane
Show all 13Show fewer
  • Clinical evidence of infection requiring systemic antimicrobial treatment
  • Documented Ebstein Barr virus infection within 7 preceding days
  • Down syndrome or other condition to affect middle ear infections
  • Known immunodeficiency
  • Vomiting or another symptom to violate per oral dosage
  • Poor parental co-operation due to language or other reasons
  • Use of any investigational drugs during the 4 preceding weeks

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

  • Department of Pediatrics, Turku University Hospital

    Turku, 20521

  • Study site

    Turku

Other trials in Finland

About this study

Official title: Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children

This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.

Being tested
amoxicillin-clavulanate, Placebo
Medical subject headings
Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • amoxicillin-clavulanateDrug

    Amoxicillin clavulanate 40 mg/kg/day divided into two daily doses for 7 days. Capsules will be produced by pulverizing amoxicillin clavulanate tablets (Augmentin 875 mg; manufacturer Glaxo SmithKline Beecham; ATC Code: J01CR02) and mixing that with lactose monohydrate. Each capsule will contain Augmentin tablet powder 68 mg and lactose monohydrate 572 mg. This means amoxicillin 40 mg and clavulanate 5,7 mg respecting the dose per 2 kg.

  • PlaceboDrug

    Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

Study groups in NCT00299455
Study groupRoleWhat they receive
1ExperimentalReconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
Receives: Drug: amoxicillin-clavulanate
2Placebo comparatorReconstituted placebo in 2 divided doses for 7 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo

    Measured: During the first 8 days of follow-up

Secondary outcomes (8)

  1. Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo

    Measured: Duration of study

  2. Time to resolution of acute inflammatory signs of middle ear

    Measured: Duration of study

  3. Compare the 2 treatment groups regarding the doses of analgesic medication and number of days analgesics are administered by children's parents

    Measured: First 7 days of follow-up

  4. Compare the 2 treatment groups regarding the number of days with absenteeism from day care and/or parental absenteeism from work

    Measured: First 7 days of follow-up

  5. Compare the incidence of adverse events accompanying the 2 treatment regimens

    Measured: Duration of study

  6. Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1

    Measured: Duration of study

  7. Time to relapse of acute otitis media

    Measured: Study days 9-17

  8. Time to first reinfection of acute otitis media

    Measured: From study day 18 to the end of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionDec 2008
  4. Study completionMar 2009 (estimated)

Resources

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
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00299455
Sponsor's protocol ID
RRR-60
Status last verified
Feb 2009
First submitted
3 Mar 2006
Last updated
11 Feb 2009
Results posted
No
Data monitoring committee
No

Publications

  • Bjorn H, Shaikh N, Laine MK, Kurs-Lasky M, Timmins H, Jalava J, Huovinen P, Lindholm L, Ruohola A, Hoberman A, Tahtinen PA. Pathogens in the Nasopharynx Before and After Antibiotic Treatment for Acute Otitis Media. Pediatr Infect Dis J. 2026 Aug 10. doi: 10.1097/INF.0000000000005346. Online ahead of print.

    PubMed 42572144

  • Uitti JM, Salantera S, Laine MK, Tahtinen PA, Ruohola A. Adaptation of pain scales for parent observation: are pain scales and symptoms useful in detecting pain of young children with the suspicion of acute otitis media? BMC Pediatr. 2018 Dec 20;18(1):392. doi: 10.1186/s12887-018-1361-y.

    PubMed 30572868

  • Ruohola A, Laine MK, Tahtinen PA. Effect of Antimicrobial Treatment on the Resolution of Middle-Ear Effusion After Acute Otitis Media. J Pediatric Infect Dis Soc. 2018 Feb 19;7(1):64-70. doi: 10.1093/jpids/pix008.

    PubMed 28340091

  • Laine MK, Tahtinen PA, Ruuskanen O, Loyttyniemi E, Ruohola A. Can trained nurses exclude acute otitis media with tympanometry or acoustic reflectometry in symptomatic children? Scand J Prim Health Care. 2015;33(4):298-304. doi: 10.3109/02813432.2015.1118835. Epub 2015 Dec 14.

    PubMed 26651157

  • Erkkola-Anttinen N, Laine MK, Tahtinen PA, Ruohola A. Parental role in the diagnostics of otitis media: can layman parents use spectral gradient acoustic reflectometry reliably? Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1516-21. doi: 10.1016/j.ijporl.2015.06.040. Epub 2015 Jul 6.

    PubMed 26183005

  • Tahtinen PA, Laine MK, Huovinen P, Jalava J, Ruuskanen O, Ruohola A. A placebo-controlled trial of antimicrobial treatment for acute otitis media. N Engl J Med. 2011 Jan 13;364(2):116-26. doi: 10.1056/NEJMoa1007174.

    PubMed 21226577

  • Laine MK, Tahtinen PA, Ruuskanen O, Huovinen P, Ruohola A. Symptoms or symptom-based scores cannot predict acute otitis media at otitis-prone age. Pediatrics. 2010 May;125(5):e1154-61. doi: 10.1542/peds.2009-2689. Epub 2010 Apr 5.

    PubMed 20368317

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing amoxicillin-clavulanate in people with Acute Otitis Media, run by University of Turku at 2 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 2 inclusion and 13 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 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo (time frame: During the first 8 days of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00299455, which also lists 7 linked publications.

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 11 Feb 2009; AzTrials last refreshed its copy on 8 Nov 2026.

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