Antibiotic pills after pituitary tumor surgery through the nose and sinuses

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults having endoscopic surgery through the nose to remove a pituitary tumor. It tests whether antibiotic pills after surgery help nose and sinus healing.

Age

Over 18 and under 85 years (record lists 18 to 84 years).

Sex

All sexes can join.

Disease stage

Pituitary tumor that does not make hormones (nonfunctioning adenoma), acromegaly, or prolactinoma, planned for endoscopic surgery.

Earlier treatment

People who had sinus surgery before cannot join. People taking antibiotics for another reason cannot join.

Main reasons for not taking part

• Cushing's disease, Rathke's Cleft cyst or pituitary cyst
• Long-term or current sinus infection, or nasal polyps
• Any organ or bone marrow transplant, or a weak immune system
• Cirrhosis, hepatitis, or kidney failure on dialysis
• Pregnancy, or severe allergy or intolerance to the study drugs

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 84 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• Standard Nasal CarePlacebo, for comparison

  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.

  Treatment: Placebo

• Standard Nasal Care + Oral AntibioticsTreatment being tested

  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.

  Treatment: Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole