NCT03014687 Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
| NCT ID | NCT03014687 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | St. Joseph's Hospital and Medical Center, Phoenix |
| Condition | Antibiotics |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2017-07-01 |
| Primary Completion | 2019-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 116 participants in total. It began in 2017-07-01 with a primary completion date of 2019-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Andrew Little, MD
STUDY CHAIR
Barrow Brain and Spine
Frequently Asked Questions
Who can join the NCT03014687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 84 Years, studying Antibiotics. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03014687 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03014687 currently recruiting?
Yes, NCT03014687 is actively recruiting participants. Contact the research team at heidi.jahnke@dignityhealth.org for enrollment information.
Where is the NCT03014687 trial being conducted?
This trial is being conducted at Phoenix, United States.
Who is sponsoring the NCT03014687 clinical trial?
NCT03014687 is sponsored by St. Joseph's Hospital and Medical Center, Phoenix. The principal investigator is Andrew Little, MD at Barrow Brain and Spine. The trial plans to enroll 116 participants.