Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions

NCT03014687 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: PHX-16-0134-30-12
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Keywords

transsphenoidal surgery

Outcome Measures

Primary Outcomes (2)

• Change in quality of life from baseline - Anterior Skull Base Nasal Inventory 12 (ASK Nasal-12)

  Completed by subject in clinic or by phone interview. Assesses urge to blow nose; post-nasal discharge; thick nasal discharge; headaches; nose makes whistling sound; nasal crusting; trouble breathing through nose during day; trouble breathing through nose during night; not breathing equally in both nostrils; sense of smell; sense of taste; and, overall functioning of nose.Rating choices include no problem 0; very minor problem 1; minor problem 2; moderate problem 3; moderately severe problem 4; and, severe problem 5. Subject also selects the 5 symptoms/items listed that impact life the most.

  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)

  Completed by subject in clinic or by phone interview. Assesses need to blow nose; nasal blockage; sneezing; runny nose; cough; post-nasal discharge; thick nasal discharge; ear fullness; dizziness; ear pain; facial pain/pressure; decreased sense of smell/taste; difficulty falling asleep; waking up at night; lack of a good night's sleep; wake up tired; fatigue; reduced productivity; reduced concentration; frustrated/restless/irritable; sad; and, embarrassed. Rating choices include no problem 0; very mild problem 1; mild or slight problem 2; moderate problem 3; severe problem 4; problem as bad as it can be 5. Subject also selects the 5 symptoms/items listed that impact life the most.

  1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery

Secondary Outcomes (7)

• Incidence of Acute Bacterial Sinusitis

  1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery

• Changes in endoscopic appearances using Postoperative Debridement Scoring Sheet (modified Lund-Kennedy score)

  1-2 and 3-4 weeks post-surgery

• Sinusitis and antibiotic resistance as evidenced by nasal congestion

  1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery

• Sinusitis and antibiotic resistance as evidenced by purulent discharge

  1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery

• Sinusitis and antibiotic resistance as evidenced by pressure

  1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery

Study Arms (2)

Standard Nasal Care

PLACEBO COMPARATOR

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.

Drug: Placebo

Standard Nasal Care + Oral Antibiotics

EXPERIMENTAL

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.

Drug: Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole

Interventions

Placebo DRUG

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.

Also known as: inert substance

Standard Nasal Care

Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole DRUG

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.

Also known as: Omnicef, Bactrim DS™ cephalosporin intolerant patients

Standard Nasal Care + Oral Antibiotics

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
• 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

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Thomas Jefferson University: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Barrow Brain and Spine

Phoenix, Arizona, 85013, United States

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Trimethoprim; Sulfamethoxazole; Cefdinir

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Cephalosporins; beta-Lactams; Lactams; Thiazines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrew Little, MD

  Barrow Brain and Spine

  STUDY CHAIR

• James Evans, MD

  Thomas Jefferson University

  STUDY CHAIR

Central Study Contacts

Heidi Jahnke, RN, MSN

CONTACT

602-406-6976; heidi.jahnke@dignityhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 9, 2017
• Study Start: July 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)