AntibioticsPhase 4POETNCT03014687
Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions
A Phase 4 study testing Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole in people with Antibiotics and Pituitary Adenoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Antibiotics, Pituitary Adenoma
- What is being tested?
- Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to Jul 2019
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barrow Brain and Spine
Phoenix, Arizona, 85013
Heidi Jahnke, RN,MSN, 602-406-6976, heidi.jahnke@dignityhealth.org
Andrew Little, MD
About this study
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
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.
Read the detailed description
Transsphenoidal surgery is the standard of care for most symptomatic pituitary adenomas. Since transsphenoidal surgery exploits the nasal passage to reach the sella turcica and pituitary gland, the technique causes disruption of sinonasal function and temporarily impacts sinonasal quality of life. Disrupted sinonasal function is a primary source of postoperative morbidity following transsphenoidal surgery. Common sinonasal complications include sinusitis, synechiae formation, nasal obstruction and crusting. The development of postoperative sinusitis is specifically associated with decreased sinonasal function after surgery. Because the nasal cavity is a contaminated surgical field, practitioners routinely prescribe a course of oral postoperative antibiotics for 7-14 days (in addition to standard prophylactic perioperative intravenous antibiotics) with the intention of improving nasal functional outcomes. To date, no studies have examined whether the administration of oral antibiotics following transsphenoidal surgery improves sinonasal healing. This question has been studied in a closely-related field, functional endoscopic sinus surgery (FESS). A meta-analysis of clinical trial data obtained in FESS indicated that current literature does not support the use of oral antibiotics to reduce infection, improve symptoms scores, or improve endoscopic findings. Furthermore, there is the potential for antibiotic-related adverse events including the emergence of bacterial resistance, Clostridium difficile infection, and allergic reactions to the medication. Despite the lack of supporting evidence in FESS, prophylactic antibiotic use for improving sinonasal healing is still common in pituitary surgery. The investigators propose to study whether prophylactic oral antibiotics following transsphenoidal surgery improve sinonasal quality of life, reduce sinusitis incidence, and promote mucosal healing following endoscopic transsphenoidal surgery.
- Conditions
- Antibiotics, Pituitary Adenoma
- Being tested
- Placebo, Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole
- Keywords
- transsphenoidal surgery
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called inert substance
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/sulfamethoxazoleDrug
Also called Omnicef, Bactrim DS™ cephalosporin intolerant patients
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Secondary outcomes (7)
Incidence of Acute Bacterial Sinusitis
Incidence includes 3 or more of: i. Nasal congestion by patient report or physical exam, ii. Purulent nasal discharge by patient report or physical exam, iii. Facial pressure or pain or headache by patient report, iv. Antibiotics prescribed by a provider for the purpose of treating sinusitis.
Measured: 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)
Postoperative nasal endoscopy findings graded by surgeon. Grading includes Polyps = none 0; middle meatus 1; beyond middle meatus 2. Discharge = none 0; clear and thin 1; thick and purulent 2. Edema = none 0; mild 1; moderate 2; severe 3. Scarring = none 0; mild 1; moderate 2; severe 3. Crusting = none 0; mild 1; moderate 2; severe 3.
Measured: 1-2 and 3-4 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced by nasal congestion
Cultures and sensitivities when nasal congestion noted by patient report or physical exam.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced by purulent discharge
Cultures and sensitivities when purulent nasal discharge noted by patient report or physical exam.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced by pressure
Cultures and sensitivities when facial pressure noted by patient report.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced by pain
Cultures and sensitivities when facial pain noted by patient report.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced headache
Cultures and sensitivities when headache noted by patient report.
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start1 Jul 2017
- Primary completionJan 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntibioticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, The Cleveland Clinic
- Responsible party
- Principal investigator, Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Andrew Little, MD, Study chair, Barrow Brain and SpineJames Evans, MD, Study chair, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014687
- Sponsor's protocol ID
- PHX-16-0134-30-12
- Acronym
- POET
- Status last verified
- Aug 2018
- First submitted
- 4 Jan 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03014687
- Acronym / sponsor ID
- POET / PHX-16-0134-30-12
- Conditions
- Antibiotics, Pituitary Adenoma
- Keywords
- transsphenoidal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Thomas Jefferson University, The Cleveland Clinic
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Transsphenoidal surgery is the standard of care for most symptomatic pituitary adenomas. Since transsphenoidal surgery exploits the nasal passage to reach the sella turcica and pituitary gland, the technique causes disruption of sinonasal function and temporarily impacts sinonasal quality of life. Disrupted sinonasal function is a primary source of postoperative morbidity following transsphenoidal surgery. Common sinonasal complications include sinusitis, synechiae formation, nasal obstruction and crusting. The development of postoperative sinusitis is specifically associated with decreased sinonasal function after surgery. Because the nasal cavity is a contaminated surgical field, practitioners routinely prescribe a course of oral postoperative antibiotics for 7-14 days (in addition to standard prophylactic perioperative intravenous antibiotics) with the intention of improving nasal functional outcomes. To date, no studies have examined whether the administration of oral antibiotics following transsphenoidal surgery improves sinonasal healing. This question has been studied in a closely-related field, functional endoscopic sinus surgery (FESS). A meta-analysis of clinical trial data obtained in FESS indicated that current literature does not support the use of oral antibiotics to reduce infection, improve symptoms scores, or improve endoscopic findings. Furthermore, there is the potential for antibiotic-related adverse events including the emergence of bacterial resistance, Clostridium difficile infection, and allergic reactions to the medication. Despite the lack of supporting evidence in FESS, prophylactic antibiotic use for improving sinonasal healing is still common in pituitary surgery. The investigators propose to study whether prophylactic oral antibiotics following transsphenoidal surgery improve sinonasal quality of life, reduce sinusitis incidence, and promote mucosal healing following endoscopic transsphenoidal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Nasal Care | Placebo comparator | Drug: PlaceboOne 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. |
| Standard Nasal Care + Oral Antibiotics | Experimental | Drug: Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazoleOne 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. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: inert substancePO 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. | Drug | Standard Nasal Care |
| Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazoleAlso: Omnicef, Bactrim DS™ cephalosporin intolerant patientsOral 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. | Drug | Standard Nasal Care + Oral Antibiotics |
Primary outcome
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
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.
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
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.
7 secondary outcomes
Incidence of Acute Bacterial Sinusitis
Time frame: 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)
Time frame: 1-2 and 3-4 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced by nasal congestion
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced by purulent discharge
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced by pressure
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced by pain
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Sinusitis and antibiotic resistance as evidenced headache
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, and 12 weeks post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Little, MD study chair
Barrow Brain and Spine
James Evans, MD study chair
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole in people with Antibiotics and Pituitary Adenoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Jahnke, RN, MSN (602-406-6976, heidi.jahnke@dignityhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.