Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Orathai Piboonpocanun, Mahidol University Identifier:
First received: July 22, 2009
Last updated: September 8, 2014
Last verified: September 2014

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

Condition Intervention
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:

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: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: azithromycin
azithrimycin 3 days/week
Drug: azithromycin
azithromycin 3 days/week
Other Name: treatment
Placebo Comparator: placebo
placebo 3 days/week
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00944515

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Orathai - Piboonpocanun, MD Siriraj Hospital, Mahidol University
  More Information

No publications provided

Responsible Party: Orathai Piboonpocanun, Department of Pediatrics, Faculty of medicine, Siriraj hospital, Mahidol University Identifier: NCT00944515     History of Changes
Other Study ID Numbers: 394/2551(EC4)
Study First Received: July 22, 2009
Last Updated: September 8, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:

Additional relevant MeSH terms:
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on February 26, 2015