Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? Protocol for a feasibility study.
Anti-Bacterial Agents
/ therapeutic use
Attitude to Health
Drug Therapy, Combination
Dysuria
/ drug therapy
Feasibility Studies
Female
Hematuria
/ drug therapy
Humans
Nocturia
/ drug therapy
Phytotherapy
Plant Extracts
/ therapeutic use
Polyuria
/ drug therapy
Primary Health Care
Qualitative Research
Urinary Tract Infections
/ complications
Vaccinium macrocarpon
Randomized Controlled Trials as Topic
Cranberry
Urinary tract infection
Vaccinium macrocarpon
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
23 Dec 2019
23 Dec 2019
Historique:
received:
20
08
2019
accepted:
28
10
2019
entrez:
25
12
2019
pubmed:
25
12
2019
medline:
17
9
2020
Statut:
epublish
Résumé
Consultations in primary care for symptoms of urinary tract infections (UTIs) are common and patients are frequently treated with antibiotics. Given increasing antimicrobial resistance, there has been interest in non-antibiotic treatment options for common infections. One such option is the use of cranberry extract to treat symptoms attributable to UTIs. A target of 45 women consulting in primary care, with symptoms suggestive of an uncomplicated UTI for whom the practitioner would normally prescribe antibiotics, will be randomised to receive one of three treatment approaches: (1) immediate prescription for antibiotics; (2) immediate prescription for antibiotics plus a 7-day course of cranberry capsules and (3) cranberry capsules plus a delayed prescription for antibiotics to be used in case their symptoms do not get better, or get worse. Follow-up will be by daily rating of symptoms and recording of treatments used for 2 weeks in an online symptom diary. Interviews will be conducted with around 10-15 study participants, as well as with around 10-15 women who have experienced a UTI but have not been approached to take part in the study. Both groups will be asked about their experience of having a UTI, their thoughts on non-antibiotic treatments for UTIs and their thoughts on, or experience of, the feasibility trial. The primary objective is to assess the feasibility of undertaking a full trial in primary care of the effectiveness of cranberry extract to reduce antibiotic use for symptoms of acute uncomplicated UTI. The secondary objective is to conduct a preliminary assessment of the extent to which cranberry might reduce antibiotic use and symptom burden. This feasibility study with embedded interviews will inform the planning and sample size calculation of an adequately powered trial to definitively determine whether cranberry helps to alleviate the symptoms of acute uncomplicated UTIs in women and whether it can safely reduce antibiotic use. ISRCTN registry, ID: 10399299. Registered on 24 January 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Consultations in primary care for symptoms of urinary tract infections (UTIs) are common and patients are frequently treated with antibiotics. Given increasing antimicrobial resistance, there has been interest in non-antibiotic treatment options for common infections. One such option is the use of cranberry extract to treat symptoms attributable to UTIs.
METHODS
METHODS
A target of 45 women consulting in primary care, with symptoms suggestive of an uncomplicated UTI for whom the practitioner would normally prescribe antibiotics, will be randomised to receive one of three treatment approaches: (1) immediate prescription for antibiotics; (2) immediate prescription for antibiotics plus a 7-day course of cranberry capsules and (3) cranberry capsules plus a delayed prescription for antibiotics to be used in case their symptoms do not get better, or get worse. Follow-up will be by daily rating of symptoms and recording of treatments used for 2 weeks in an online symptom diary. Interviews will be conducted with around 10-15 study participants, as well as with around 10-15 women who have experienced a UTI but have not been approached to take part in the study. Both groups will be asked about their experience of having a UTI, their thoughts on non-antibiotic treatments for UTIs and their thoughts on, or experience of, the feasibility trial. The primary objective is to assess the feasibility of undertaking a full trial in primary care of the effectiveness of cranberry extract to reduce antibiotic use for symptoms of acute uncomplicated UTI. The secondary objective is to conduct a preliminary assessment of the extent to which cranberry might reduce antibiotic use and symptom burden.
DISCUSSION
CONCLUSIONS
This feasibility study with embedded interviews will inform the planning and sample size calculation of an adequately powered trial to definitively determine whether cranberry helps to alleviate the symptoms of acute uncomplicated UTIs in women and whether it can safely reduce antibiotic use.
TRIAL REGISTRATION
BACKGROUND
ISRCTN registry, ID: 10399299. Registered on 24 January 2019.
Identifiants
pubmed: 31870413
doi: 10.1186/s13063-019-3860-z
pii: 10.1186/s13063-019-3860-z
pmc: PMC6929469
doi:
Substances chimiques
Anti-Bacterial Agents
0
Plant Extracts
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
767Subventions
Organisme : NIHR School for Primary Care Research
ID : SPCR-2014-10043 413 and SPCR-2014-10043 417
Organisme : Wellcome Trust
ID : 203921/Z/16/Z
Pays : United Kingdom
Organisme : National Institute for Health Research
ID : Senior Investigator award
Organisme : National Institute for Health Research
ID : Collaboration for Leadership in Applied Health Research
Organisme : National Institute for Health Research
ID : Evidence synthesis working group (project 390)
Organisme : National Institute for Health Research
ID : BRC
Organisme : Oxford Health NHS Foundation Trust
ID : Care Oxford
Organisme : Indena S.p.A
ID : Supplying cranberry capsules
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