NCT00299455

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

2.8 years

First QC Date

March 3, 2006

Last Update Submit

February 10, 2009

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

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

    During the first 8 days of follow-up

Secondary Outcomes (8)

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

    Duration of study

  • Time to resolution of acute inflammatory signs of middle ear

    Duration of study

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

    First 7 days of follow-up

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

    First 7 days of follow-up

  • Compare the incidence of adverse events accompanying the 2 treatment regimens

    Duration of study

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.

Drug: amoxicillin-clavulanate

2

PLACEBO COMPARATOR

Reconstituted placebo in 2 divided doses for 7 days.

Drug: Placebo

Interventions

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.

1
PlaceboDRUG

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

2

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Acute otitis media
  • Age 6 - 35 mo

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics, Turku University Hospital

Turku, 20521, Finland

Location

Unknown Facility

Turku, Finland

Location

Related Publications (6)

  • 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.

    PMID: 30572868DERIVED

  • 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.

    PMID: 28340091DERIVED

  • 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.

    PMID: 26651157DERIVED

  • 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.

    PMID: 26183005DERIVED

  • 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.

    PMID: 21226577DERIVED

  • 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.

    PMID: 20368317DERIVED

MeSH Terms

Conditions

Otitis Media

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Aino Ruohola, MD, PhD

    Pediatrician

    PRINCIPAL INVESTIGATOR

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

March 3, 2006

First Posted

March 6, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

FI(2)