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New treatment option for Antibiotics
Official title Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
ClinicalTrials.gov ID: NCT03014687
What this study is testing
What is Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole?
Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for antibiotics.
Also referred to as Omnicef, Bactrim DS™ cephalosporin intolerant patients.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 84
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.