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Standard Nasal Care + Oral Antibiotics for Antibiotics (POET Trial)

Phase 4
Recruiting
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Awards & highlights

POET Trial Summary

To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection (sinusitis), and helps mucosal healing in the nasal passages.

Eligible Conditions
  • Antibiotics
  • Pituitary Adenomas

POET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12)
Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22)
Secondary outcome measures
Changes in endoscopic appearances using Postoperative Debridement Scoring Sheet (modified Lund-Kennedy score)
Incidence of Acute Bacterial Sinusitis
Sinusitis and antibiotic resistance as evidenced by nasal congestion
+4 more

POET Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard Nasal Care + Oral AntibioticsExperimental Treatment1 Intervention
One dose of preoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg) will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Participants will receive 1 dose only of postoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg [cephalosporin allergic patients]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Oral antibiotics will commence on the morning of postoperative day 1; this group will receive oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.
Group II: Standard Nasal CarePlacebo Group1 Intervention
One dose of preoperative intravenous (iv) antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Postoperative antibiotics: Study participants will receive one dose only of postoperative intravenous antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg [cephalosporin allergic patients]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Placebo PO BID (twice daily) will commence on the morning of postoperative day 1 and continue for 7 days.

Find a Location

Who is running the clinical trial?

St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,501 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
445 Previous Clinical Trials
145,873 Total Patients Enrolled
The Cleveland ClinicOTHER
1,030 Previous Clinical Trials
1,365,442 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
Pam Dewey 2017. "Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03014687.
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