DO GENITOURINARY MYCOPLASMA SPECIES CAUSE DISEASE?
Research type
Research Study
Full title
ARE MYCOPLASMA SPECIES ASSOCIATED WITH DISEASE IN THE GENITOURINARY SYSTEM OF MALE AND FEMALE PATIENTS ATTENDING SEXUAL HEALTH CLINICS OR ARE THEY BACTERIAL COMMENSALS?
IRAS ID
253889
Contact name
Lucy Jones
Contact email
Sponsor organisation
Cwm Taf UHB
Clinicaltrials.gov Identifier
NOT APPLICABLE, NOT APPLICABLE
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The purpose of this study is to determine if the presence of Mycoplasma and Ureaplasma bacteria caused clinical signs and symptoms in participants of the MYCO WELL D-ONE study (IRAS: 230693). The secondary objective of the study is to determine if there are any clinical parameters and sexual behaviours that are associated with Mycoplasma and Ureaplasma infection.
Mycoplasmas and Ureaplasmas are bacteria that are increasingly thought to be associated with disease. The British Association for Sexual Health and HIV has recently published that non-gonococcal urethritis may be caused by Mycoplasmas and Ureaplasmas and have recently issued new clinical guidelines for the detection and management of these infections in sexually active patients. Mycoplasma has been associated with recurrent bacterial vaginosis, pelvic inflammatory disease and preterm birth. Recent advances in medical diagnostics for detection of Mycoplasma show that the prevalence of Mycoplasma infection may be increasing in the UK. The alleged burden of genitourinary disease associated with these infections is, however, a much debated issue as there have been very few large, research studies in the UK that have determined whether Mycoplasma and Ureaplasma are present as commensals or as pathogens.
We evaluated a novel near-patient diagnostic, MYCO WELL D-ONE, on 1000 patients attending sexual health clinics in the UK (IRAS reference: 230693). The MYCO WELL D-ONE test detects the presence of Mycoplasma spp and Ureaplasma spp and determines the antimicrobial resistance of these bacteria. MYCO WELL D-ONE is a very good diagnostic tool for the detection of Mycoplasma spp. and Ureaplasma spp and determination of antimicrobial resistance
We would like to examine if positive Mycoplasma and Ureaplasma test results were associated with disease in participants of this study and assess if there are any clinical parameters that are associated with this.REC name
West of Scotland REC 5
REC reference
18/WS/0208
Date of REC Opinion
7 Nov 2018
REC opinion
Favourable Opinion