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Beta-lactamase inhibitor

Treatment A for Respiratory Infection

Phase 3
Waitlist Available
Led By Ellen R Wald, MD
Research Sponsored by Nader Shaikh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 to 11, where day 1 is day of enrollment
Awards & highlights

Study Summary

This trial is testing whether some kids with sinus infections can be treated without antibiotics.

Eligible Conditions
  • Respiratory Infection
  • Sinus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 to 11, where day 1 is day of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 to 11, where day 1 is day of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
Secondary outcome measures
The Distribution of Children Compliant With Study Medication
The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up
The Distribution of Children Experiencing Treatment Failure (TF)
+2 more
Other outcome measures
The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment AActive Control1 Intervention
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
Group II: Treatment BPlacebo Group1 Intervention
Placebo made to match the study antibiotic will be taken bid orally for 10 days

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,484,722 Total Patients Enrolled
Nader ShaikhLead Sponsor
2 Previous Clinical Trials
658 Total Patients Enrolled
Ellen R Wald, MDPrincipal InvestigatorUniversity of Wisconsin, American Family Children's Hospital
10 Previous Clinical Trials
2,453 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to people who are octogenarians or above?

"Based on the inclusion criteria outlined for this clinical trial, the minimum age requirement for participants is 2 years old, with an upper limit of 11 years old."

Answered by AI

Are there any available positions for willing test subjects in this experiment?

"This particular clinical trial has wrapped up recruitment, with the study's first posting on February 1, 2016 and most recent update on October 10, 2022. There are, however, 147 other studies currently recruiting patients with sinusitis and 60 trials for Treatment A that are still looking for participants."

Answered by AI

How many men and women will be participating in this clinical trial?

"This particular study is no longer recruiting patients. The trial began on February 1st, 2016 and the most recent update was on October 10th, 2022. However, there are 147 other trials for sinusitis and 60 for Treatment A that are still looking for volunteers."

Answered by AI

If this isn't the first time Treatment A has been tested, where can I find information about its previous successes or failures?

"Treatment A was first researched in 2011 by the Department of Pediatrics at Daping Hospital. So far, 18515 trials have completed, with 60 more currently active. Many of these active studies are happening in Gresham, Oregon."

Answered by AI

Is it permissible to market Treatment A in the United States?

"There is some evidence from previous trials to support the efficacy of Treatment A, and it has undergone multiple rounds of testing to ensure its safety. Therefore, our team has given it a score of 3."

Answered by AI

In how many hospitals is this trial being conducted?

"Currently, this study is being conducted at 4 sites. 2 of these sites are in Gresham and Bardstown, with the other 2 located in Pittsburgh and other cities. If you are interested in participating, please select the site that is closest to your location to minimize travel."

Answered by AI

What is the primary reason why Treatment A is used?

"Treatment A is effective against communicable diseases, bronchitis, upper respiratory tract infection, and septicemia."

Answered by AI

Are there specific inclusionary criteria for this trial?

"In this particular trial, 688 children aged 2-11 that suffer from sinusitis are being enrolled. Most importantly, potential candidates must have a baseline score of 9 or higher on the Pediatric Rhinosinusitis Symptom Scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Nader Shaikh 2016. "Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02554383.
~56 spots leftby Apr 2025
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