Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
| Status: | Completed |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2013 |
| End Date: | April 2013 |
| Contact: | Emily Cohn, BSPH |
| Email: | emily_cohn@med.unc.edu |
| Phone: | 9193570977 |
A Randomized Cohort Trial Evaluating Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics
as part of maximal medical therapy for treating chronic sinusitis and thus preventing
patients from having to have sinus surgery. The hypothesis is that in the context of maximal
medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at
successfully treating chronic sinusitis.
as part of maximal medical therapy for treating chronic sinusitis and thus preventing
patients from having to have sinus surgery. The hypothesis is that in the context of maximal
medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at
successfully treating chronic sinusitis.
OVERVIEW This is a prospective randomized cohort study assessing duration of antibiotics (3
vs 6 weeks) as part of maximal medical therapy for chronic rhinosinusitis. Up to 100
subjects will be prospectively enrolled from patients visiting the Department of
Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals.
INITIAL CLINIC VISIT At the time of a clinical visit, the attending otolaryngologists will
identify their patients with chronic rhinosinusitis (CRS) who are appropriate for maximal
medical treatment, including antibiotics. They will introduce the study to these patients
and invite them to learn more about it.
If the patient is interested in learning more about the study, the study coordinators will
be contacted to provide additional information and, if the patient would like to participate
in the study, provide informed consent.
If the patient is a premenopausal woman, she will be asked if she is pregnant or
breastfeeding.
If she is either of these, she will be excluded from the study. All remaining women will
receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will
be excluded from the study. Thus, for premenopausal female patients, a negative urine
pregnancy test is necessary for inclusion in the study. These women will be informed that
they should use an effective method of birth control during the study:
- Combined oral contraceptives
- Patch contraceptives
- Vaginal ring contraceptives
- Injectable contraceptives
- Implantable contraceptives
- Intrauterine devices or intrauterine systems
- Tubal ligation
- Barrier methods of contraception (male condom, female condom, cervical cap with
spermicide, or diaphragm with spermicide)
- Vasectomy of your partner in a monogamous relationship
Women enrolled in this study will be informed that if they have a failure of birth control
method during the course of the study or become pregnant during the study, they will be
withdrawn from the study and further treatment will be decided according to the clinical
withdrawn from the study and further treatment will be decided according to the clinical
expertise of the treating otolaryngologist.
- The study coordinators will assign the patients a unique Subject ID that will be used
on all patient forms with the exception of the informed consent documents and HIPAA
authorization forms.
- The patient will fill out a demographics and past medical history form.
- The patient will fill out two quality of life surveys: the Rhinosinusitis Disability
Index (RSDI) and the Chronic Sinusitis Survey (CSS).
- Video recorded nasal endoscopy will be performed by the attending physician. The video
file will be stored initially on a portable storage drive that will contain no patient
identifiers. The file will be identified only with the SubjectID. The patient's face
will not be recorded in the video. The file on the portable storage drive will be
transferred to a password protected computer in the locked office of the principal
investigator.
- Using a random-number generator, the patient will be randomized to receive either 3 or
6 weeks of antibiotics.
- The subject will initially be given a prescription for empiric antibiotics.The choice
of empiric antibiotics will differ based on the patient's nasal polyposis status:
- If the subject has CRS with nasal polyposis (CRSwNP), s/he will be given Doxycycline
100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for either 3 or 6
weeks duration. These patients will also receive a course of Prednisone (30mg x 3d,
20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of
care treatment for CRSwNP.
- If the subject has CRS without Nasal Polyposis (CRSwNP), s/he will be given
Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for
either 3 or 6 weeks duration.
- If purulent nasal discharge is present that is appropriate for culture, the
otolaryngologists will send this for culture and sensitivity analysis, which they would
normally do as part of their routine clinical care. The patients will be informed that
if their culture and sensitivity analysis indicates that they have an infection that
can be treated with a less broad-spectrum antibiotic, then they will be prescribed
culture-directed antibiotics. Otherwise, the patient can continue empiric antibiotics
as previously specified.
- All study participants will also be prescribed standard of care intranasal steroids,
and encouraged to perform BID saline sinus irrigation and use yogurt/over the counter
probiotics to reduce GI side effects of antibiotics.
AFTER THE INITIAL CLINIC VISIT
The study personnel will access the patient's medical record via WebCIS to:
- Record the patient's allergy status, CBC with differential and IgE at the time of the
initial visit. CBC and IgE labs are part of the routine clinical care for CRS. If these
are not obtained during the initial clinic visit, they will be obtained at a later
clinic visit (visit 2 or future pre-operative visit)
- View the patient's pre-treatment sinus CT scan and calculate a blinded Lund-Mackay
score.
4-5 WEEKS AFTER BEGINNING TREATMENT
For subjects randomized to the 3 week antibiotic group, these subjects will been seen in
clinic.
During this visit (study visit #2), subjects will complete the RSDI and CSS. Subjects will
be asked about antibiotic compliance and side effects. Recommendation for sinus surgery will
be evaluated with video-recorded nasal endoscopy and a sinus CT.
For subjects randomized to the 6 week antibiotic group, these subjects will be contacted by
phone by the study coordinator to assess side effects and medication compliance.
7-8 WEEKS AFTER BEGINNING TREATMENT
For subjects randomized to the 6 week antibiotic group, these subjects will been seen in
clinic.
During this visit (study visit #2), subjects will complete the RSDI and CSS. Subjects will
be asked about antibiotic compliance and side effects. Recommendation for sinus surgery will
be evaluated with video-recorded nasal endoscopy and a sinus CT.
At any of these study visits or a potential pre-operative visit, subjects will have blood
drawn to record IgE and CBC with differential. These labs are routinely ordered in CRS both
to characterize the disease and also for pre-operative planning.
All video recorded nasal endoscopies will be blindly scored by Drs. Senior, Ebert, and
Zanation with the Lund-Kennedy scoring system. All sinus CTs will be scored with the
Lund-Mackay scoring system.
vs 6 weeks) as part of maximal medical therapy for chronic rhinosinusitis. Up to 100
subjects will be prospectively enrolled from patients visiting the Department of
Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals.
INITIAL CLINIC VISIT At the time of a clinical visit, the attending otolaryngologists will
identify their patients with chronic rhinosinusitis (CRS) who are appropriate for maximal
medical treatment, including antibiotics. They will introduce the study to these patients
and invite them to learn more about it.
If the patient is interested in learning more about the study, the study coordinators will
be contacted to provide additional information and, if the patient would like to participate
in the study, provide informed consent.
If the patient is a premenopausal woman, she will be asked if she is pregnant or
breastfeeding.
If she is either of these, she will be excluded from the study. All remaining women will
receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will
be excluded from the study. Thus, for premenopausal female patients, a negative urine
pregnancy test is necessary for inclusion in the study. These women will be informed that
they should use an effective method of birth control during the study:
- Combined oral contraceptives
- Patch contraceptives
- Vaginal ring contraceptives
- Injectable contraceptives
- Implantable contraceptives
- Intrauterine devices or intrauterine systems
- Tubal ligation
- Barrier methods of contraception (male condom, female condom, cervical cap with
spermicide, or diaphragm with spermicide)
- Vasectomy of your partner in a monogamous relationship
Women enrolled in this study will be informed that if they have a failure of birth control
method during the course of the study or become pregnant during the study, they will be
withdrawn from the study and further treatment will be decided according to the clinical
withdrawn from the study and further treatment will be decided according to the clinical
expertise of the treating otolaryngologist.
- The study coordinators will assign the patients a unique Subject ID that will be used
on all patient forms with the exception of the informed consent documents and HIPAA
authorization forms.
- The patient will fill out a demographics and past medical history form.
- The patient will fill out two quality of life surveys: the Rhinosinusitis Disability
Index (RSDI) and the Chronic Sinusitis Survey (CSS).
- Video recorded nasal endoscopy will be performed by the attending physician. The video
file will be stored initially on a portable storage drive that will contain no patient
identifiers. The file will be identified only with the SubjectID. The patient's face
will not be recorded in the video. The file on the portable storage drive will be
transferred to a password protected computer in the locked office of the principal
investigator.
- Using a random-number generator, the patient will be randomized to receive either 3 or
6 weeks of antibiotics.
- The subject will initially be given a prescription for empiric antibiotics.The choice
of empiric antibiotics will differ based on the patient's nasal polyposis status:
- If the subject has CRS with nasal polyposis (CRSwNP), s/he will be given Doxycycline
100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for either 3 or 6
weeks duration. These patients will also receive a course of Prednisone (30mg x 3d,
20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of
care treatment for CRSwNP.
- If the subject has CRS without Nasal Polyposis (CRSwNP), s/he will be given
Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for
either 3 or 6 weeks duration.
- If purulent nasal discharge is present that is appropriate for culture, the
otolaryngologists will send this for culture and sensitivity analysis, which they would
normally do as part of their routine clinical care. The patients will be informed that
if their culture and sensitivity analysis indicates that they have an infection that
can be treated with a less broad-spectrum antibiotic, then they will be prescribed
culture-directed antibiotics. Otherwise, the patient can continue empiric antibiotics
as previously specified.
- All study participants will also be prescribed standard of care intranasal steroids,
and encouraged to perform BID saline sinus irrigation and use yogurt/over the counter
probiotics to reduce GI side effects of antibiotics.
AFTER THE INITIAL CLINIC VISIT
The study personnel will access the patient's medical record via WebCIS to:
- Record the patient's allergy status, CBC with differential and IgE at the time of the
initial visit. CBC and IgE labs are part of the routine clinical care for CRS. If these
are not obtained during the initial clinic visit, they will be obtained at a later
clinic visit (visit 2 or future pre-operative visit)
- View the patient's pre-treatment sinus CT scan and calculate a blinded Lund-Mackay
score.
4-5 WEEKS AFTER BEGINNING TREATMENT
For subjects randomized to the 3 week antibiotic group, these subjects will been seen in
clinic.
During this visit (study visit #2), subjects will complete the RSDI and CSS. Subjects will
be asked about antibiotic compliance and side effects. Recommendation for sinus surgery will
be evaluated with video-recorded nasal endoscopy and a sinus CT.
For subjects randomized to the 6 week antibiotic group, these subjects will be contacted by
phone by the study coordinator to assess side effects and medication compliance.
7-8 WEEKS AFTER BEGINNING TREATMENT
For subjects randomized to the 6 week antibiotic group, these subjects will been seen in
clinic.
During this visit (study visit #2), subjects will complete the RSDI and CSS. Subjects will
be asked about antibiotic compliance and side effects. Recommendation for sinus surgery will
be evaluated with video-recorded nasal endoscopy and a sinus CT.
At any of these study visits or a potential pre-operative visit, subjects will have blood
drawn to record IgE and CBC with differential. These labs are routinely ordered in CRS both
to characterize the disease and also for pre-operative planning.
All video recorded nasal endoscopies will be blindly scored by Drs. Senior, Ebert, and
Zanation with the Lund-Kennedy scoring system. All sinus CTs will be scored with the
Lund-Mackay scoring system.
Inclusion Criteria:
- Diagnosis of chronic rhinosinusitis
- 18 years of age or older
- English speaking
Exclusion Criteria:
- Pregnant or breastfeeding women
- vasculitis
- cystic fibrosis
- primary ciliary dyskinesia
- allergic fungal sinusitis
- gross immunodeficiency
- current use of chemotherapy
- insulin-dependent diabetes mellitus
- recent trial of maximal medical therapy
We found this trial at
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Chapel Hill, North Carolina 27514
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