Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

This study is currently recruiting participants.

Verified July 2011 by Mahidol University

First Received on July 22, 2009. Last Updated on July 21, 2011 History of Changes

Sponsor:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00944515

Purpose

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

Condition	Intervention
Sinusitis	Drug: placebo Drug: azithromycin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children : A Prospective, Randomized, Double-blind, Placebo Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

frequence of acute sinusitis during 12 mouths of study period [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: azithromycin	Drug: azithromycin azithromycin 5 mg/kg/day, 3 days/week Other Name: treatment
Placebo Comparator: placebo	Drug: placebo placebo tablet or syrup 3 days/week Other Name: placebo

Detailed Description:

A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in preventing recurrent acute sinusitis in children

Eligibility

Ages Eligible for Study:	5 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944515

Contacts

Contact: Orathai Piboonpocanun

662-419-8888 ext 5942

jirapongo@yahoo.com

Locations

Thailand
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University	Recruiting
Bangkok, Thailand, 10700
Contact: Orathai Piboonpocanun, Assoc.Prof. 662-419-7000 ext 5942 jirapongo@yahoo.com
Principal Investigator: Orathai Piboonpocanun, Assoc.Prof.

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator:

Orathai - Piboonpocanun, MD

Siriraj Hospital, Mahidol University

More Information

No publications provided

Responsible Party:	Orathai Piboonpocanun, Dept of pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University.
ClinicalTrials.gov Identifier:	NCT00944515 History of Changes
Other Study ID Numbers:	394/2551(EC4)
Study First Received:	July 22, 2009
Last Updated:	July 21, 2011
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

sinusitis
azithromycin

Additional relevant MeSH terms:

Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012