Recruiting

Oral Antibiotics

Sponsor:

St. Joseph's Hospital and Medical Center, Phoenix

Code:

NCT03014687

Conditions

Antibiotics

Pituitary Adenoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole

Study Details

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.

Conditions

Antibiotics

Pituitary Adenoma

Study ID

NCT03014687

Start date

Jul 1, 2017

Status verified date

Aug, 2018

Completion date

Jul, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Standard Nasal Care

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.

experimental: Standard Nasal Care + Oral Antibiotics

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.

Interventions

Placebo

PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.

Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole

Oral antibiotics (cefdinir \[Omnicef®\] 300 mg PO BID or trimethoprim/sulfamethoxazole \[Bactrim DS™\] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.

Primary outcome measure

  • Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]
  • Change in quality of life from baseline - Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery ]

Central Contacts and Locations

Central contacts

Locations

Barrow Brain and Spine

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Principal Investigator:

Andrew Little, MD

More Information

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Last update posted

Aug 15, 2018

Last verified

Aug, 2018

Keywords

  • transsphenoidal surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix on 2018-08-15.