Clarithromycin and endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps: study protocol for the MACRO randomised controlled trial.
Administration, Oral
Anti-Bacterial Agents
/ administration & dosage
Chronic Disease
Clarithromycin
/ administration & dosage
Comparative Effectiveness Research
Drug Administration Schedule
Endoscopy
/ adverse effects
Female
Humans
Male
Multicenter Studies as Topic
Nasal Polyps
/ diagnosis
Nasal Surgical Procedures
/ adverse effects
Pilot Projects
Randomized Controlled Trials as Topic
Rhinitis
/ diagnosis
Sinusitis
/ diagnosis
Time Factors
Treatment Outcome
United Kingdom
chronic rhinosinusitis
clarithromycin
endoscopic sinus surgery
randomised controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
29 Apr 2019
29 Apr 2019
Historique:
received:
27
11
2018
accepted:
21
03
2019
entrez:
1
5
2019
pubmed:
1
5
2019
medline:
18
12
2019
Statut:
epublish
Résumé
Chronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be included in primary medical management, reflecting the lack of evidence in systematic reviews. Insufficient evidence to inform the role of surgery contributes to a fivefold variation in UK intervention rates. The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months. A three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clarithromycin (250 mg) or (3) intranasal medication plus a placebo. Intranasal medication (current standard medical care) is defined as a spray or drops of intranasal corticosteroids and saline irrigations. The primary outcome measure is the SNOT-22 questionnaire, which assesses disease-specific health-related quality of life. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted in at least 16 secondary or tertiary care centres with an internal pilot at six sites for 6 months. The potential cardiovascular side effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through this trial, which may help to reduce unnecessary usage and potential morbidity. If ESS is shown to be clinically effective and cost-effective, the trial may encourage earlier intervention. In contrast, if it is shown to be ineffective, then there should be a significant reduction in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with CRS and design the ideal patient pathway across primary and secondary care. ISRCTN36962030 . Registered on 17 October 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Chronic rhinosinusitis (CRS) is a common source of ill health; 11% of UK adults reported CRS symptoms in a worldwide population study. Guidelines are conflicting regarding whether antibiotics should be included in primary medical management, reflecting the lack of evidence in systematic reviews. Insufficient evidence to inform the role of surgery contributes to a fivefold variation in UK intervention rates. The objective of this trial is to establish the comparative effectiveness of endoscopic sinus surgery (ESS) or a prolonged course of antibiotics (clarithromycin) in adult patients with CRS in terms of symptomatic improvement and costs to the National Health Service compared with standard medical care (intranasal medication) at 6 months.
METHODS/DESIGN
METHODS
A three-arm parallel-group trial will be conducted with patients who remain symptomatic after receiving appropriate medical therapy (either in primary or secondary care). They will be randomised to receive: (1) intranasal medication plus ESS, (2) intranasal medication plus clarithromycin (250 mg) or (3) intranasal medication plus a placebo. Intranasal medication (current standard medical care) is defined as a spray or drops of intranasal corticosteroids and saline irrigations. The primary outcome measure is the SNOT-22 questionnaire, which assesses disease-specific health-related quality of life. The study sample size is 600. Principal analyses will be according to the randomised groups irrespective of compliance. The trial will be conducted in at least 16 secondary or tertiary care centres with an internal pilot at six sites for 6 months.
DISCUSSION
CONCLUSIONS
The potential cardiovascular side effects of macrolide antibiotics have been recently highlighted. The effectiveness of antibiotics will be established through this trial, which may help to reduce unnecessary usage and potential morbidity. If ESS is shown to be clinically effective and cost-effective, the trial may encourage earlier intervention. In contrast, if it is shown to be ineffective, then there should be a significant reduction in surgery rates. The trial results will feed into the other components of the MACRO research programme to establish best practice for the management of adults with CRS and design the ideal patient pathway across primary and secondary care.
TRIAL REGISTRATION
BACKGROUND
ISRCTN36962030 . Registered on 17 October 2018.
Identifiants
pubmed: 31036048
doi: 10.1186/s13063-019-3314-7
pii: 10.1186/s13063-019-3314-7
pmc: PMC6489242
doi:
Substances chimiques
Anti-Bacterial Agents
0
Clarithromycin
H1250JIK0A
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
246Subventions
Organisme : Medical Research Council
ID : MR/K006584/1
Pays : United Kingdom
Organisme : Department of Health
ID : NIHR-RP-011-045
Pays : United Kingdom
Organisme : Department of Health
ID : RP-PG-0614-20011
Pays : United Kingdom
Organisme : Programme Grants for Applied Research
ID : RP-PG-0614-20011
Investigateurs
Neil Med
(N)
Keith Boland
(K)
Jane Woods
(J)
Teresa Ferreira
(T)
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