Acute Sinusitis and Antibiotics

Protocol Description

This study, funded by the National Institutes of Health (NIH), will help determine which children with acute sinusitis can be observed without antibiotics and which children, if any, benefit from immediate antibiotic treatment.

Sinusitis (a sinus infection) is one of the most common illnesses in children. Some children diagnosed as having acute sinusitis may actually have an uncomplicated cold or upper respiratory infection caused by a virus, which cannot be cured with antibiotics. Only when bacteria cause the infection are antibiotics helpful. Without antibiotics, most sinus infections eventually get better. Antibiotics often have side effects, such as diarrhea or allergic reactions, and antibiotics can cause germs in the child’s body to become resistant, making it harder to treat infections in the future. The American Academy of Pediatrics recommends physicians either start children with sinusitis on antibiotics or observe them for a few days before deciding on the need for antibiotics. With this study, researchers hope to define criteria to determine which option is better for which patients.

Benefits

Children in this study will have the benefit of a clinician monitoring their symptoms on a daily basis. If symptoms worsen or do not improve as expected, patients can be evaluated without delay and treated with rescue antibiotics. Parents/guardians will have 24-hour access to study physicians, who will arrange a study visit, usually within 24 hours. There are no charges for study related visits.

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting participants of both genders, ages 2 through 11, who have been diagnosed with acute sinusitis during the respiratory season.
Boys and girls: Ages 2 through 11 years

Requirements

Children enrolled in the study will be randomly selected to take either the antibiotic Augmentin or a placebo for 10 days. The parent/guardian will be required to keep a daily diary of their child’s symptoms, which will be reviewed each day by the study team. There will be a final visit at the end of the treatment period. Extra visits will be scheduled for children who are not improving quickly.
Visits: 2, or more as needed
Duration: Up to 18 days

Status: Open to Enrollment

Source(s) of Support

National Institute of Allergy and Infectious Diseases

Additional Information

• Study Description at National Institutes of Health
• Study Consent Form (PDF)
• General Academic Pediatrics Research

Primary Investigator

Nader Shaikh, MD, MPH

Contact Information

For more information about the study or enrollment, please contact:
412-996-COLD (2653)