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2016 ; 16
(1
): 484
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
A randomized controlled study of 5 and 10 days treatment with
phenoxymethylpenicillin for pharyngotonsillitis caused by streptococcus group A -
a protocol study
#MMPMID27618925
Skoog G
; Edlund C
; Giske CG
; Mölstad S
; Norman C
; Sundvall PD
; Hedin K
BMC Infect Dis
2016[Sep]; 16
(1
): 484
PMID27618925
show ga
BACKGROUND: In 2014 the Swedish government assigned to The Public Health Agency
of Sweden to conduct studies to evaluate optimal use of existing antibiotic
agents. The aim is to optimize drug use and dosing regimens to improve the
clinical efficacy. The present study was selected following a structured
prioritizing process by independent experts. METHODS: This phase IV study is a
randomized, open-label, multicenter study with non-inferiority design regarding
the therapeutic use of penicillin V with two parallel groups. The overall aim is
to study if the total exposure with penicillin V can be reduced from 1000 mg
three times daily for 10 days to 800 mg four times daily for 5 days when treating
Streptococcus pyogenes (Lancefield group A) pharyngotonsillitis. Patients will be
recruited from 17 primary health care centers in Sweden. Adult men and women,
youth and children ?6 years of age who consult for sore throat and is judged to
have a pharyngotonsillitis, with 3-4 Centor criteria and a positive rapid test
for group A streptococci, will be included in the study. The primary outcome is
clinical cure 5-7 days after discontinuation of antibiotic treatment. Follow-up
controls will be done by telephone after 1 and 3 months. Throat symptoms,
potential relapses and complications will be monitored, as well as adverse
events. Patients (n?=?432) will be included during 2 years. DISCUSSION: In the
era of increasing antimicrobial resistance and the shortage of new antimicrobial
agents it is necessary to revisit optimal usage of old antibiotics. Old
antimicrobial drugs are often associated with inadequate knowledge on
pharmacokinetics and pharmacodynamics and lack of optimized dosing regimens based
on randomized controlled clinical trials. If a shorter and more potent treatment
regimen is shown to be equivalent with the normal 10 day regimen this can imply
great advantages for both patients (adherence, adverse events, resistance) and
the community (resistance, drug costs). TRIAL REGISTRATION: EudraCT number
2015-001752-30 . Protocol FoHM/Tonsillit2015 date 22 June 2015, version 2.
Approved by MPA of Sweden 3 July 2015, Approved by Regional Ethical Review Board
in Lund, 25 June 2015.
|*Streptococcus pyogenes
[MESH]
|Adolescent
[MESH]
|Adult
[MESH]
|Anti-Bacterial Agents/administration & dosage/*therapeutic use
[MESH]
|Child
[MESH]
|Clinical Protocols
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Male
[MESH]
|Penicillin V/administration & dosage/*therapeutic use
[MESH]
free
free
free
