Are patients experiencing undetected Chlamydia treatment failure?
Research type
Research Study
Full title
Are there patients experiencing undetected treatment failure for Chlamydia trachomatis infection in the NCSP cohort, screened through GP surgeries, in England?
IRAS ID
158701
Contact name
Kevin Dunbar
Contact email
Sponsor organisation
Public Health England
Research summary
The National Chlamydia Screening Program (NCSP) provided 1,782,122 Chlamydia trachomatis tests (from all settings) to 15 to 24 year olds, diagnosing 136,961 cases of chlamydia in 2012 and recommends single dose therapy with azithromycin (1g) as the treatment of choice (in line with current BASHH guidelines). Extended use of single dose antimicrobial treatment as a first line recommended therapy for C. trachomatis has raised concerns regarding the development of antimicrobial resistance in this organism and, whilst stable homotypic resistance has yet to be documented, there have been anecdotal reports of treatment failure.
The Sexually Transmitted Bacteria Reference Unit (STBRU) has been collecting isolates, through GU medicine, from patients who are persistently infected with C. trachomatis since 2008. Enhanced surveillance data collected from these patients has shown that conversely to the normal disease profile, the majority of the patients were symptomatic at initial presentation or went on to develop symptoms after treatment had been initiated. It is not unreasonable to assume that these patients were prompted to return to clinic due to their on-going or developing symptoms. Due to the lack of a recommended test-of-cure for C. trachomatis positive patients up until recently, there is little to no information available about treatment failure within asymptomatic patients (which make up the majority of cases) and this is usually attributed to re-infection.
This study aims to investigate whether there is a reservoir of patients being screened by the NCSP in GPs surgeries in England, who are failing treatment for C. trachomatis infection. As the NCSP provide opportunistic screening the selection bias for symptomatic patients should be removed allowing analysis of patients with asymptomatic infections as well as symptomatic infections. Patients persistently infected with C. trachomatis will be identified using at home, self-collected, test-of-cure packs to be returned to STBRU for nucleic acid amplification testing. Patients will then be recalled for further treatment and culture swab collection. Antimicrobial susceptibility testing will be performed on isolates collected generating vital data about the susceptibility of circulating strains in these patients.
REC name
London - Queen Square Research Ethics Committee
REC reference
14/LO/1621
Date of REC Opinion
29 Sep 2014
REC opinion
Favourable Opinion