The aim of this study is to determine the optimal anatomical sample site for the evaluation of CT viability by comparing the total CT load (as determined by route NAAT) and viable CT load (by V-PCR) from different anatomical sample sites.
ID
Source
Brief title
Condition
- Chlamydial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is assessment of the viable CT concentration
(viable load) at any of the anatomical sample locations.
Other parameters used in this study as determinants to understand the endpoint
are:
-CT detection by commercial NAAT (standard routine care; CT positive Yes/No)
-CT DNA concentration (total CT load)
-CT detection by culture (reference method for viable CT detection; Viable CT
Yes/No)
For exploratory descriptive analysis we will investigate associated factors
from self-reported questionnaire data (e.g. demographics, sexual behaviour,
symptoms, etc.). These questionnaires are completed by patients as part of the
standard routine care.
Secondary outcome
Not applicable.
Background summary
The introduction of nucleic acid amplification tests (NAATs) have
revolutionized our ability to diagnose Chlamydia trachomatis (CT). In some
cases, however, assessment of CT viability is needed * a feature that has been
lost with the expanded use of molecular diagnostic techniques * to gain more
insight in the clinical diagnostic impact of NAAT. Recently, alternative
methods to assess the CT viability have become available (e.g. viability-PCR;
V-PCR) and demonstrated high amounts of dead bacteria in self-collected swab
samples (i.e., vaginal and anal swabs). Further research is needed to assess
the impact on V-PCR results of anatomical sample sites (i.e., vaginal vs.
cervical and anal vs. rectal swabs) which may vary in the amount of viable
organisms.
Study objective
The aim of this study is to determine the optimal anatomical sample site for
the evaluation of CT viability by comparing the total CT load (as determined by
route NAAT) and viable CT load (by V-PCR) from different anatomical sample
sites.
Study design
Explorative cross-sectional study. At the treatment visit, CT positive women
are asked to undergo a speculum examination (after written informed consent) to
obtain clinician-collected cervical and vaginal swab samples. Furthermore,
clinician-collected swabs will be collected from alternate anatomical locations
(i.e., oral, anal, and the perineum). Additionally, after written informed
consent, patients undergo a proctoscopic examination to obtain swab samples
from the rectum. Swab samples from each anatomical site will be evaluated for
CT positivity by routine NAAT and for the total and viable CT load by V-PCR.
For exploratory descriptive analysis we will investigate associated factors
from coded self-reported questionnaire data (e.g. demographics, sexual
behaviour, symptoms, etc.). These questionnaires are completed by patients as
part of the standard routine care.
Study burden and risks
There are no direct benefits for the patients who participate as the results of
the swabs are not reported to them individually. They participate
altruistically to help science to improve CT control and help inform guideline
optimization. The burden for participating patients lies in the discomfort a
gynaecological speculum examination and optionally a proctoscopy might entail.
These procedures pose minimal risk, rarely cause pain, and are mostly done
within 10 minutes, so duration is quite short and therefore acceptable for
participating patients although some discomfort is not excluded. These
procedures are part of the regular health care procedure in certain conditions
(symptomatic patients) but here patients are asked to participate fully
voluntary within a setting they already know (after all they are already an STI
clinic patient) and they are familiar with the guiding, comforting and
trustworthy STI physicians and nurses. Speculum examination including sample
collection will take about 15 minutes. An experienced study clinician will
collect 10 swab samples (2 oral, 2 cervical, 2 vaginal, 2 anal, and 2 from the
perineum; total 15 minutes). Futhermore, after additional written informed
consent, two rectal swabs will be collected by the same experienced study
clinician during proctoscopic examination of the rectum which will take about
10 minutes. Patients will participate individually and fully voluntary after
reading the patient information about the study and after signing written
informed consent. No specific subgroups are targeted in this study other than
CT positive women attending the STI clinic. Epidemiologic and laboratory data
analysis will be performed on coded data and data will not be traceable to
individuals. Results will not be available for the patients. Patients only will
benefit indirectly because of potential optimization of future STI patient care
and improved CT control. Results from this study might have public health
impact.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: women, age 18 years or older, genital or anorectal CT diagnosis, and signed written informed consent.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: concurrently infected with Neisseria gonorrhoea (i.e., having an oral, vaginal or anal infection), previously diagnosed HIV or Syphilis, recent (<1 month) use of any antibiotics with some effect on chlamydia trachomatis (excluding e.g. frequently used metronidazole and nitrofurantoine), and being pregnant.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67843.068.18 |