Using oral antibiotics after pituitary surgery to improve nasal outcomes
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Impact of Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
Run by St. Joseph's Hospital and Medical Center, Phoenix · NCT03014687 · Data updated 2026-11-12
This study is testing if taking oral antibiotics after pituitary surgery can help improve healing in the nose and reduce sinus problems for patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | St. Joseph's Hospital and Medical Center, Phoenix Academic / other |
| Locations | 1 site (Phoenix, Arizona) |
| Status | Recruiting |
| Started | July 1, 2017 |
| Main results expected | January 2019 |
| Study ends | July 2019 |
| Registry record updated | August 15, 2018 |
| Trial ID | NCT03014687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 85 undergoing endoscopic surgery for nonfunctioning pituitary adenomas, acromegaly, or prolactinoma.
✕Probably not a fit
Patients with a history of chronic sinusitis, active sinusitis, or those who have had previous sinus surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether administering oral antibiotics after endoscopic transsphenoidal surgery for pituitary adenomas can enhance sinonasal healing, reduce the incidence of postoperative sinusitis, and improve nasal symptoms. The research involves a randomized controlled trial comparing the effects of oral antibiotics (cefdinir or trimethoprim/sulfamethoxazole) against a placebo. The study aims to address the gap in knowledge regarding the efficacy of postoperative antibiotics in this specific surgical context, as previous studies in related fields have shown mixed results. Participants will be monitored for sinonasal function and quality of life using validated scales.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and quality of life for patients undergoing pituitary surgery.
How similar studies have gone: Previous studies in related fields, such as functional endoscopic sinus surgery, have not supported the use of oral antibiotics for improving outcomes, indicating this study's approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient undergoing endoscopic surgery for resection of pituitary tumors for nonfunctioning adenoma, acromegaly, or prolactinoma * Adults \>18 and \<85 years of age * English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales * Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable Exclusion Criteria: * Anaphylaxis/intolerance to the study drugs * Cirrhosis, hepatitis * Any solid organ transplant or bone marrow transplant. And any patient felt to be immunocompromised by the investigators * Renal failure on dialysis * Any subject who is unwilling or unable to sign informed consent for the study * Pregnancy * Incarcerated patients * Cushing's disease * Rathke's Cleft cyst or pituitary cyst * History of chronic sinusitis * Anticipated use of nasal splints * Anticipated use of nasal septal flap * Active sinusitis * Nasal polyps * Previous sinus surgery * Concurrent antibiotics for another indication (i.e., urinary tract infection) * Immunodeficiency
Where it's running
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Barrow Brain and Spine
Phoenix, Arizona, United States Recruiting
Study contacts
- Study coordinator: Heidi Jahnke, RN, MSN
- Email: heidi.jahnke@dignityhealth.org
- Phone: 602-406-6976
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.