NCT00944515

Brief Summary

The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

6.3 years

First QC Date

July 22, 2009

Last Update Submit

March 15, 2016

Conditions

Sinusitis

Keywords

sinusitisazithromycin

Outcome Measures

Primary Outcomes (1)

  • frequence of acute sinusitis during 12 mouths of study period

    12 months

Study Arms (2)

azithromycin

ACTIVE COMPARATOR

azithrimycin 3 days/week

Drug: azithromycin

placebo

PLACEBO COMPARATOR

placebo 3 days/week

Drug: placebo

Interventions

placeboDRUG

placebo tablet or syrup 3 days/week

placebo
azithromycinDRUG

azithromycin 3 days/week

Also known as: treatment
azithromycin

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children between the age of 5 years and 15 years with the diagnosis of recurrent acute sinusitis who are attending the outpatient pediatric department, pediatric allergy clinic, and the ear, nose, throat clinic.

You may not qualify if:

  • patients who have allergic rhinitis, chronic sinusitis, a history of allergic reactions to azithromycin or macrolides, treatments with immunotherapy or IVIG or gentamycin solution or pneumococcal vaccine during study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Sinusitis

Interventions

AzithromycinTherapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Orathai - Piboonpocanun, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Pediatrics, Faculty of medicine, Siriraj hospital

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)