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Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT01825408
Recruitment Status : Completed
First Posted : April 5, 2013
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Adam Zanation, MD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sinusitis
Interventions Drug: Doxycycline
Drug: Azithromycin
Drug: Augmentin
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxycycline, 3 Weeks Doxycycline, 6 Weeks Azithromycin, 3 Weeks Azithromycin, 6 Weeks
Hide Arm/Group Description

Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 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 patients with chronic sinusitis with nasal polyps.

Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 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 patients with chronic sinusitis with nasal polyps.

Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.

Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.

Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Period Title: Overall Study
Started 7 7 14 12
Completed 7 7 14 12
Not Completed 0 0 0 0
Arm/Group Title Doxycycline, 3 Weeks Doxycycline, 6 Weeks Azithromycin, 3 Weeks Azithromycin, 6 Weeks Total
Hide Arm/Group Description

Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 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 patients with chronic sinusitis with nasal polyps.

Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 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 patients with chronic sinusitis with nasal polyps.

Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.

Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.

Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Total of all reporting groups
Overall Number of Baseline Participants 7 7 14 12 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants 12 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  85.7%
7
 100.0%
11
  78.6%
9
  75.0%
33
  82.5%
>=65 years
1
  14.3%
0
   0.0%
3
  21.4%
3
  25.0%
7
  17.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants 12 participants 40 participants
Female
3
  42.9%
2
  28.6%
8
  57.1%
8
  66.7%
21
  52.5%
Male
4
  57.1%
5
  71.4%
6
  42.9%
4
  33.3%
19
  47.5%
1.Primary Outcome
Title Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy
Hide Description Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.
Time Frame 4-5 weeks after starting antibiotics
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline, 3 Weeks Azithromycin, 3 Weeks
Hide Arm/Group Description:

Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 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 patients with chronic sinusitis with nasal polyps.

Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.

Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Overall Number of Participants Analyzed 7 14
Measure Type: Count of Participants
Unit of Measure: Participants
Sinus Surgery Recommended
7
 100.0%
8
  57.1%
Sinus Surgery NOT Recommended
0
   0.0%
6
  42.9%
2.Primary Outcome
Title Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy
Hide Description Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.
Time Frame 7-8 weeks after initiating antibiotics
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline, 6 Weeks Azithromycin, 6 Weeks
Hide Arm/Group Description:

Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 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 patients with chronic sinusitis with nasal polyps.

Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.

Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Overall Number of Participants Analyzed 7 12
Measure Type: Count of Participants
Unit of Measure: Participants
Sinus Surgery Recommended
5
  71.4%
8
  66.7%
Sinus Surgery NOT Recommended
2
  28.6%
4
  33.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxycycline, 3 Weeks Doxycycline, 6 Weeks Azithromycin, 3 Weeks Azithromycin, 6 Weeks
Hide Arm/Group Description

Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 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 patients with chronic sinusitis with nasal polyps.

Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 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 patients with chronic sinusitis with nasal polyps.

Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.

Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.

Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.

Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration

All-Cause Mortality
Doxycycline, 3 Weeks Doxycycline, 6 Weeks Azithromycin, 3 Weeks Azithromycin, 6 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Doxycycline, 3 Weeks Doxycycline, 6 Weeks Azithromycin, 3 Weeks Azithromycin, 6 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%)   0/14 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxycycline, 3 Weeks Doxycycline, 6 Weeks Azithromycin, 3 Weeks Azithromycin, 6 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   1/7 (14.29%)   0/14 (0.00%)   1/12 (8.33%) 
Gastrointestinal disorders         
Diarrhea  0/7 (0.00%)  1/7 (14.29%)  0/14 (0.00%)  1/12 (8.33%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Adam Zanation
Organization: UNC Department of Otolaryngology
EMail: adam_zanation@med.unc.edu
Layout table for additonal information
Responsible Party: Adam Zanation, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01825408     History of Changes
Other Study ID Numbers: 12-2377
First Submitted: March 18, 2013
First Posted: April 5, 2013
Results First Submitted: February 16, 2017
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017